Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Despite being a relatively quiet year for 

 in terms of groundbreaking new research, the 

 has been very active over the last 12 months, with new approvals and revisions to old therapies. Hormone replacement therapy (HRT) for both men and women has evolved significantly after a long period of stagnation, and everything from growth hormone deficiency (GHD) to adrenal insufficiency has seen major new therapeutic options added to their treatment repertoires.

With the end of the year rapidly approaching, the editorial team at 

 has collected 9 of the most impactful headlines across hormonal disorders from 2025. Catch up on any news you may have missed below.


FDA Approves Lonapegsomatropin-tcgd (Skytrofa), Formerly TransCon hGH, for Adult Growth Hormone Deficiency

On July 28, 2025, the FDA approved lonapegsomatropin-tcgd for adult GHD, based on data from the phase 3 foresiGHt clinical trial. The somatropin prodrug achieved superiority in trunk fat reductions and body lean mass increase from baseline when compared to placebo. Additionally, lonapegsomatropin-tcgd appeared safe and well-tolerated for the duration of the trial, with no discontinuations related to the study drug.


FDA Approves Paltusotine (Palsonify) As First Once-Daily, Oral Acromegaly Treatment

On September 25, 2025, Crinetics Pharmaceuticals announced the FDA’s approval of paltusotine for first-line treatment of adults with acromegaly who had an inadequate response to surgery or who are unable to undergo surgery. The selectively targeted somatostatin receptor type 2 agonist is now the first once-daily oral treatment approved for this condition – the approval was based on data from the phase 3 PATHFNDR-1 and PATHFNDR-2 trials. In both, paltusotine displayed rapid onset, reliable biochemical control, and sustained efficacy for the duration.


FDA Approves Hydrocortisone Oral Solution for Adrenal Insufficiency

On May 28, 2025, the FDA approved hydrocortisone oral solution for pediatric patients ≥5 years with adrenocortical insufficiency, addressing administration and dosing accuracy in patients who may have difficulty swallowing pills or with special administration needs. Adrenal insufficiency is a rare but serious condition, decreasing the production of aldosterone and cortisol via reduced adrenal gland function and potentially leading to high morbidity and mortality. This new treatment provides an additional option to meet the needs of both clinicians and patients.


FDA initiates removal of boxed warnings, requests updated labeling for menopausal hormone therapy

On November 10, 2025, the FDA and the US Department of Health and Human Services announced their plan to revise safety labeling for menopausal hormone therapy, also known as hormone replacement therapy. After reevaluating data from the original Women’s Health Initiative (WHI) trial, which was conducted in the 1990s, both agencies determined that the substantially older patient group from WHI does not properly represent the average age of menopause onset in the US. To this end, the FDA requested several labeling changes, including the removal of language in boxed warnings related to cardiovascular disease, breast cancer, and dementia, as well as adding WHI data for women aged 50-59 years.


FDA issues labeling changes for testosterone products following TRAVERSE, postmarket studies

On March 3, 2025, the FDA issued a class-wide labeling change for testosterone products, based on new findings from the phase 4 TRAVERSE trial and from required postmarket ambulatory blood pressure monitoring studies. These postmarket trials resulted in suggestions to add product-specific information on increased blood pressure and a new warning about increased blood pressure for testosterone products without a current warning, while TRAVERSE led to the FDA suggesting retaining “limitation of use” language for age-related hypogonadism and removing language from the boxed warning related to increased risk of adverse cardiovascular outcomes, as well as posting the results of TRAVERSE on the products directly.


Mohit Khera, MD, recaps key takeaways from FDA panel on TRT for men

 in December of 2025 to address the recent FDA panel on labeling of testosterone replacement therapy (TRT) for men. The panel was a turning point in TRT, marking the beginning of the FDA revisiting historical and long-standing perspectives on testosterone. Key points from the panel included outdated label language and reconsidering testosterone’s classification as a Schedule III controlled substance.


Crinecerfont Shows Lasting Efficacy in Treating Adult CAH, with Richard Auchus, MD, PhD

Data from year 1 of the phase 3 CAHtalyst clinical trial, investigating crinecerfont in adult patients with congenital adrenal hyperplasia, were presented at ENDO 2025, showing the drug’s efficacy in reducing excessive adrenal androgen production and thereby reducing the amount of glucocorticoid treatment necessary to return patients to equilibrium. CAHtalyst compared crinecerfont to placebo, with the former providing a 27.3% reduction in glucocorticoid doses compared to 10.3% in the latter.


Karyn S. Eilber, MD, shares her reaction to genitourinary syndrome of menopause guidelines

The 2025 American Urological Association Annual Meeting saw the release of the “Genitourinary Syndrome of Menopause: AUA/SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction/American Urogynecologic Society) Guideline,” which described in detail the symptoms and physical changes caused by declining estrogen and androgen concentrations in the genitourinary tract during menopause. Karen Eilber, MD, discusses the importance of a full, complete diagnosis of these symptoms so that treatment strategies can be undertaken in the future.


Diabetes Dialogue: CATALYST Trial, Mifepristone, and Hypercortisolism in T2D, with John Buse, MD, PhD

In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, spoke with John Buse, MD, PhD, about the phase 4 CATALYST trial, which suggests that mifepristone substantially improves glycemic control, reduces body weight, and lowers waist circumference in patients with hypercortisolism and difficult-to-control 

. While part 1 of the trial saw patients undergo dexamethasone suppression testing to identify hypercortisolism, part 2 randomized 136 patients to either mifepristone or placebo for 24 weeks. Despite the drug’s proven efficacy, however, 49% of patients discontinued therapy, compared to 18% in placebo.

Articles

The FDA has been active in approving and revising therapies for hormonal disorders, including new treatments for growth hormone deficiency, acromegaly, and adrenal insufficiency. Notable approvals include lonapegsomatropin-tcgd for adult GHD, paltusotine for acromegaly, and a hydrocortisone oral solution for pediatric adrenal insufficiency. The FDA has also initiated changes in labeling for menopausal hormone therapy and testosterone products. Additionally, clinical trials like CAHtalyst and CATALYST have shown promising results for congenital adrenal hyperplasia and hypercortisolism in type 2 diabetes, respectively.

Catch up on the most impactful headlines in hormonal disorders from all of 2025 with our Year in Review.

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Hormonal Disorders in 2025: Year in Review

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

After years of limited therapeutic movement, 2025 marked a notable inflection point in fibromyalgia research and clinical care. The condition—long characterized by central sensitization, nonrestorative sleep, and persistent pain—has remained one of the most challenging chronic syndromes to manage, with few effective options and frequent reliance on multimodal, trial-and-error strategies. This year brought renewed attention to fibromyalgia through regulatory action, late-stage trial data, and growing interest in neuromodulatory and nonpharmacologic approaches.

At the center of this shift was the FDA approval of TNX-102 SL (Tonmya) in August 2025, the first new fibromyalgia therapy approved in more than 15 years. Targeting nonrestorative sleep rather than pain alone, the sublingual, non-opioid therapy reflects an evolving understanding of fibromyalgia biology and opened the door to a broader conversation about mechanism-driven treatment. Subsequent phase 3 data readouts reinforced its efficacy and safety profile, while clinician commentary highlighted both its promise and its limitations within real-world, multimodal care.

Beyond pharmacotherapy, 2025 also delivered important insights from trials of neuromodulation and supportive interventions, including rTMS, TENS combined with physical therapy, and a sobering negative study of low-dose naltrexone. Together, these developments underscore a year defined not by a single breakthrough, but by incremental progress across multiple fronts—pointing toward a future of more personalized, mechanism-specific, and integrated fibromyalgia management.

FDA Approves TNX-102 SL, First New Fibromyalgia Therapy in 15 Years

On August 15, the FDA approved TNX-102 SL (Tonmya), the first new fibromyalgia therapy in more than 15 years, offering a novel sublingual, non-opioid approach that targets nonrestorative sleep to improve pain and other core symptoms. Approval was based on the phase 3 RESILIENT trial, where the drug showed significant pain reduction as early as week 1 along with improvements in sleep and fatigue.

TNX-102 SL Data Supports Recent Fibromyalgia Approval

New phase 3 data from the RESILIENT and RELIEF trials, presented at PAINWEEK 2025, confirmed that TNX-102 SL (Tonmya) significantly reduced pain in fibromyalgia compared with placebo, supporting its recent FDA approval as the first new treatment for the condition in over 15 years. At Week 14 in RESILIENT, patients receiving TNX-102 SL had a mean weekly pain score of 4.1 versus 4.7 with placebo, with all six secondary endpoints also met. The therapy was well-tolerated, with low discontinuation rates and no unexpected safety signals.

TMS Reduces Pain, Yields Functional Improvements in Women With Fibromyalgia

A clinical study demonstrated that M1-repetitive transcranial magnetic stimulation (rTMS) significantly reduced fibromyalgia pain for up to eight weeks, with sustained functional improvements lasting 16 weeks. The findings support rTMS as a noninvasive neuromodulatory option for fibromyalgia management.

TENS With Physical Therapy Meaningfully Reduced Fibromyalgia Movement-Evoked Pain

Adding transcutaneous electrical nerve stimulation (TENS) to routine physical therapy significantly reduced movement-evoked pain, fatigue, and resting pain in people with fibromyalgia, with benefits persisting for at least 6 months in a real-world clinical setting. Presented at ACR Convergence 2025, the pragmatic FM-TIPS trial supports TENS as a safe, accessible, and durable adjunct to physical therapy for fibromyalgia management.

Low-Dose Naltrexone Shows No Significant Effects in People With Fibromyalgia

Low-dose naltrexone did not improve pain outcomes in women with fibromyalgia compared with placebo in the randomized FINAL trial, reinforcing prior findings that LDN lacks efficacy for average pain intensity. Although an exploratory signal was observed in conditioned pain modulation, investigators concluded the difference was likely spurious and not linked to meaningful pain improvement, underscoring the need for adequately powered studies before clinical adoption.

Reframing Fibromyalgia Care in 2025: Restricted Impact of TNX-102 SL’s Approval

The FDA approval of TNX-102 SL in August 2025 marked the first new fibromyalgia drug approval in more than 15 years, introducing a sleep-targeted, non-opioid approach aimed at addressing nonrestorative sleep as a core driver of symptoms. Clinicians view the therapy as a meaningful but incremental advance that may benefit selected patients when integrated into multimodal care, rather than a standalone solution for this complex, heterogeneous condition.

Johnson V. FDA Approves TNX-102 SL, First New Fibromyalgia Therapy in 15 Years. Article. HCPLive. August 15, 2025. https://www.hcplive.com/view/fda-approves-tnx-102-sl-first-new-fibromyalgia-therapy-in-15-years

Johnson V. TNX-102 SL Data Supports Recent Fibromyalgia Approval. Article. HCPLive. September 12, 2025. https://www.hcplive.com/view/tnx-102-sl-data-supports-recent-fibromyalgia-approval

Johnson V. TMS Reduces Pain, Yields Functional Improvements in Women With Fibromyalgia. Article. HCPLive. March 24, 2025. https://www.hcplive.com/view/tms-reduces-pain-yields-functional-improvements-fibromyalgia

Johnson V. TENS With Physical Therapy Meaningfully Reduced Fibromyalgia Movement-Evoked Pain. Article. HCPLive. October 27, 2025. https://www.hcplive.com/view/tens-pt-meaningfully-reduced-fibromyalgia-movement-evoked-pain

Johnson V. Low-Dose Naltrexone Shows No Significant Effects in People With Fibromyalgia. Article. HCPLive. April 16, 2025. https://www.hcplive.com/view/low-dose-naltrexone-no-significant-effects-fibromyalgia

Johnson V. taVNS Reduces Pain, Improves Mood in Fibromyalgia Patients. Article. HCPLive. December 19, 2025. https://www.hcplive.com/view/tavns-reduces-pain-improves-mood-fibromyalgia-patients

Mease PJ, Zangoglia N, Sharobeem A. Reframing Fibromyalgia Care in 2025: Restricted Impact of TNX-102 SL’s Approval. Article. December 30, 2025. https://www.hcplive.com/view/reframing-fibromyalgia-care-2025-restricted-impact-tnx-102-sl-approval

In 2025, fibromyalgia research and treatment saw significant advancements, highlighted by the FDA approval of TNX-102 SL (Tonmya), the first new therapy in over 15 years. This sublingual, non-opioid medication targets nonrestorative sleep, reflecting a shift towards mechanism-driven treatments. Clinical trials confirmed its efficacy and safety, while neuromodulation techniques like rTMS and TENS showed promise in pain reduction. However, low-dose naltrexone failed to demonstrate significant benefits. These developments suggest a future of more personalized and integrated fibromyalgia management, though challenges remain.

The fibromyalgia year in review highlights FDA approvals, data, and advances in 2025.

Fibromyalgia

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Fibromyalgia in 2025: Year in Review

Emerging Innovations in Post-Event Lipid Management for ASCVD

The panelists conclude by examining emerging innovations in post-event lipid management aimed at improving outcomes for patients with ASCVD. They highlight a shift toward earlier initiation of intensive LDL-C lowering—beginning during hospitalization or soon after discharge—to prevent recurrent events during the period of highest vulnerability. The experts discuss the growing use of siRNA-based therapies such as inclisiran and the development of next-generation PCSK9-targeting agents that combine potency with simplified dosing schedules to improve adherence. They also note increasing interest in combination approaches, including pairing statins with bempedoic acid or PCSK9-directed therapies for sustained LDL-C control. The conversation underscores the importance of integrating lipid management into hospital discharge planning and ensuring seamless transitions to outpatient care. The panelists express optimism that continued innovation—coupled with improved access and education—will help clinicians achieve earlier, more durable LDL-C reduction and ultimately reduce recurrent ASCVD events.

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Experts discuss groundbreaking innovations in cardiovascular disease prevention, highlighting personalized medicine and new therapies for effective treatment.

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Sustaining Long-Term Adherence to PCSK9 Therapy in ASCVD

The panelists discuss strategies to improve long-term adherence to PCSK9-targeting therapies among patients with ASCVD. They note that while these agents are highly effective, adherence often declines after the first year due to cost, complex refill processes, and perceived lack of symptoms once LDL-C levels normalize. The experts emphasize that successful long-term use depends on simplifying care pathways, such as incorporating pharmacy-led coordination, automated refill reminders, and structured follow-up visits. They highlight the advantage of siRNA-based therapies like inclisiran, which require administration only twice per year, reducing the burden of self-injection and improving persistence. The panelists also stress the importance of patient education—helping individuals understand that LDL-C reduction is a lifelong goal, not a short-term fix. By combining streamlined delivery models, consistent communication, and shared accountability among the care team, clinicians can sustain adherence and maximize the benefits of PCSK9 therapy in ASCVD management.

Engaging patients in their treatment journey enhances adherence to therapies, ultimately improving health outcomes and managing cholesterol effectively.

 care has existed in a therapeutic holding pattern. Clinicians have relied on a small group of FDA-approved medications—duloxetine, milnacipran, and pregabalin—alongside off-label agents, nonpharmacologic strategies, and trial-and-error symptom management. While these approaches have helped subsets of patients, they have fallen short for many others, leaving fibromyalgia one of the most challenging chronic pain syndromes to manage in routine clinical practice.

That landscape shifted in August 2025, when the US Food and Drug Administration approved TNX-102 SL (Tonmya) for the treatment of adults with fibromyalgia, marking the first new drug approved for the indication in more than 15 years.

 The decision introduced not only a new therapeutic option, but also a different conceptual target: nonrestorative sleep, long recognized as a core driver of fibromyalgia symptoms but rarely addressed directly by approved therapies.

The approval arrives amid a broader transformation in pain medicine. Earlier in 2025, the FDA approved 

, a non-opioid pain signal inhibitor, as the first new drug class for acute pain in more than 2 decades.

 Together, these approvals signal renewed momentum in novel, non-opioid pain innovation, yet they also highlight how much work remains, particularly for complex, heterogeneous conditions like fibromyalgia.

Insights from clinicians across rheumatology, rehabilitation, and integrative pain care suggest that TNX-102 SL may meaningfully expand the fibromyalgia toolkit—but that its impact will depend on access, patient selection, expectations, and how it is integrated into broader, multimodal care strategies.

Targeting Nonrestorative Sleep in Fibromyalgia

Fibromyalgia is defined not by structural damage or overt inflammation, but by central nervous system dysregulation—a constellation of altered pain processing, sleep disruption, fatigue, and cognitive symptoms. This complexity has made it resistant to single-target pharmacologic solutions. The pain experienced in fibromyalgia cannot be fully explained by peripheral injury or inflammatory disease activity. Even in patients with well-controlled autoimmune or musculoskeletal disease, fibromyalgia symptoms may persist, reflecting what pain researchers now classify as nociplastic pain that is driven by altered neural processing rather than tissue damage. Sleep disturbance is a central part of this phenomenon.

TNX-102 SL is a sublingual formulation of cyclobenzaprine, designed to optimize overnight pharmacokinetics and target sleep-related mechanisms without residual daytime effects. Unlike oral cyclobenzaprine, the sublingual formulation bypasses first-pass hepatic metabolism, reducing formation of long-lived metabolites and allowing for a more controlled overnight exposure.

The FDA approval was based on data from the phase 3 RESILIENT trial, which demonstrated statistically significant improvements in daily pain scores, sleep disturbance, fatigue, and sleep quality compared with placebo. The study included 457 patients with fibromyalgia receiving TNX-102 SL 5.6 mg administered before bedtime (n = 231) or placebo (n = 226). Participants were mostly female (n = 436; 95.4%) and were mostly White/Caucasian (n = 386; 84.5%). They had a mean duration of 9.2 years of fibromyalgia disease (standard deviation [SD], 9.0) and a mean 5.9 (SD, 1.1) numeric rating scale (NRS) pain score at baseline. Investigators found that TNX-102 SL demonstrated a highly statistically significant improvement in the primary endpoint of statistically significantly reducing daily NRS pain scores compared with placebo starting at week 1 and continuing until Week 14 (P <.0001), with an effect size of 0.38.

Importantly, improvements were observed early and sustained across the study period, supporting the concept that targeting sleep physiology can influence core fibromyalgia symptoms. From a clinical perspective, this represents a meaningful shift. Rather than treating pain as an isolated symptom, TNX-102 SL aligns with a growing recognition that sleep dysfunction is a central driver of fibromyalgia, not merely a secondary complaint.

“I am aware that some rheumatologists have commented that it will just be an expensive version of generic, oral cyclobenzaprine, but the fact that it was able to show statistical separation from placebo and has a unique mechanism of action that yields more enduring effect during the nighttime’s sleep cycles, and that its bioavailability is greater, all add up to our wanting to use it,” Philip Mease, MD, director of Rheumatology Research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, told 

However, clinicians caution against viewing the approval as a cure or a comprehensive solution. Fibromyalgia remains a heterogeneous condition, and sleep-targeted therapy alone is unlikely to address all contributing mechanisms in every patient.

TNX-102 SL as a Tool, Not a Transformation for Fibromyalgia

Clinicians anticipate that TNX-102 SL will be used primarily in patients with persistent symptoms despite prior therapy, particularly those in whom sleep disruption is prominent and limiting. For patients who have cycled through existing approved medications or experienced waning benefit over time, a new mechanism of action offers a rationale for re-engagement with pharmacologic care.

“Especially with the patients who are dealing with high levels of pain and really limitations to function, where even conservative management we can only get so far, that's when the medical management really can make a big difference,” Nicole Zangoglia, PT, DPT, a physical therapist with a concierge practice, said.

At the same time, clinicians emphasize that real-world uptake will hinge on insurance coverage, prior authorization requirements, and patient cost-sharing. As with many specialty medications, administrative barriers could limit access, blunting the drug’s real-world impact despite positive trial data.

“Assuming that the cost to the patient will not be exorbitant, assuming insurance coverage, and that there will be a reasonably non-onerous prior authorization process, we do plan to prescribe TNX-102 SL in our practice, based on the efficacy and safety data demonstrated in the phase 3 trials,” Mease said.

While the approval has been widely described as a milestone, some clinicians urge restraint in characterizing it as a transformative moment for fibromyalgia care. From this perspective, TNX-102 SL represents an incremental advance rather than a paradigm shift.

Fibromyalgia management has long required multimodal care, including physical therapy, behavioral interventions, sleep hygiene, stress management, and patient education. Pharmacologic treatments can support function and symptom control, but they rarely address the full scope of autonomic, neurologic, and psychosocial dysregulation involved.

“In my practice we’re always trying to bridge the gap between conservative care and medical management, because there's a role for both. And a lot of the times, if one can only get so far, we need a little assistance from the other. So there's always, it's always exciting when there's other opportunities that are non conservative, so that we have some resources and some something else to try for patients who are still struggling. So I haven't seen too much of the effects of that yet, but I'd be definitely excited to see where that goes,” Zangoglia said.

There is concern that new medications, however welcome, risk being positioned as standalone solutions rather than integrated components of comprehensive care. In this view, fibromyalgia treatment has historically fallen into cycles of enthusiasm followed by disappointment, as new drugs fail to deliver durable, system-level change. It is necessary to reframe expectations for this new addition to the fibromyalgia landscape. TNX-102 SL may help patients function better, sleep more effectively, and reduce pain intensity—but it is unlikely to “reset” the underlying dysregulation that characterizes fibromyalgia for many individuals.

A recurring theme among clinicians is that fibromyalgia reflects a dysregulated autonomic and central nervous system, shaped by genetic vulnerability, stress exposure, illness, and chronic pain signaling. Once established, this dysregulation can become self-sustaining.

“This type of pain may need different approaches to effectively treat. So whilst immunomodulatory medicines may effectively treat inflammation and reduce classic nociceptive pain, adjunctive approaches may be needed to treat nociplastic pain. This may also reduce the tendency to keep changing the patient’s immunomodulatory medicine, if inflammation is well controlled. Along with this education, we are hoping to see measures of nociplastic pain used in clinical trials and in clinical practice to aid clinicians to navigate this complexity,” Mease said.

Pharmacologic agents can modulate symptoms within this system, but they may not fundamentally rewire it. This has fueled growing interest in nonpharmacologic neuromodulation approaches, including transcranial magnetic stimulation, vagus nerve stimulation, and other device-based therapies aimed at restoring autonomic balance.

“I'm a very big fan of the holistic approach… creating medications that seemingly just band aid the issue is kind of my point of contention… I understand where it fits in… however, that kind of band aid like effect… has fallen short, as we see with the other handful of medications that we have that are FDA approved, which are not too robust,” Andrew Sharobeem, DO, a rheumatologist at Arizona Arthritis & Rheumatology Associates, told 

While these approaches remain investigational or limited in availability, they reflect a broader recognition that fibromyalgia likely requires multi-level intervention, spanning sleep, neural processing, physical function, and psychological resilience.

Against this backdrop, TNX-102 SL may serve as a supportive therapy—one that helps stabilize sleep and reduce symptom intensity while other modalities address deeper contributors to disease persistence.

Fibromyalgia in the Context of 2025 Pain Innovation

The approval of TNX-102 SL does not stand alone. In January 2025, the FDA approved suzetrigine, a selective NaV1.8 sodium channel inhibitor, for moderate to severe acute pain, marking the first new drug class for acute pain in more than 20 years.

Suzetrigine’s approval reflects a broader regulatory and scientific push toward non-opioid pain therapies that target specific biological mechanisms rather than broadly suppressing pain perception. Although suzetrigine is approved for acute pain and TNX-102 SL for chronic fibromyalgia, both approvals underscore renewed momentum in pain drug development after years of stagnation.

Importantly, these agents address different domains of pain biology. Suzetrigine targets peripheral nociceptive signaling, while TNX-102 SL targets sleep-related central sensitization. Together, they illustrate how pain medicine is moving away from one-size-fits-all approaches toward more mechanism-specific interventions.

Fibromyalgia’s Future: Progress With Perspective

The approval of TNX-102 SL in 2025 represents a meaningful step forward for fibromyalgia care, offering a novel, non-opioid option that directly targets a core feature of the disease: nonrestorative sleep. For patients who have cycled through existing therapies with limited success, it provides a new avenue worth exploring.

“I look forward to seeing RWE from long term clinical registries, to see if addition of this medication makes a difference, in settings not as controlled as clinical trials, with even more complex patients, there is improvement of pain, fatigue, and sleep disturbance. [In terms of other investigations with] long COVID and PTSD... there is overlapping pathophysiology with FM, including features of pain, fatigue and sleep disturbance, so I think it is worthwhile to consider use of this drug in these and other conditions that are at least partially characterized as central sensitization,” Mease said.

Clinicians agreed: no single medication is likely to resolve a condition defined by central sensitization, autonomic imbalance, and multifactorial symptom drivers. TNX-102 SL may improve quality of life for some patients, but it does not eliminate the need for comprehensive, multidisciplinary care—or for continued innovation beyond symptom management.

“It's great to have something like [TNX-102 SL] to avoid, certain medications that we know are not going to be great, like opioids, and are going to cause way more side effects than they do benefit. But, it's not that big splash that I'm looking forward to,” Sharobeem said.

Viewed alongside other 2025 pain approvals such as suzetrigine, TNX-102 SL reflects a broader reawakening in pain drug development. The challenge now is to ensure that these advances are integrated thoughtfully, equitably, and realistically into care models that recognize both the biology and the lived experience of chronic pain.

Johnson V. FDA Approves Suzetrigine, a Non-Opioid Option, for Treatment of Acute Pain. Article. HCPLive. January 30, 2025. https://www.hcplive.com/view/fda-approves-suzetrigine-a-non-opioid-option-for-treatment-of-acute-pain

Iglehart III I, Sullivan G, Lederman S. Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (Tnx-102 SL) Targets Nonrestorative Sleep and Provides Sustained Pain Reduction.

The approval of TNX-102 SL (Tonmya) by the FDA in 2025 marks a significant advancement in fibromyalgia treatment, targeting nonrestorative sleep—a core symptom of the condition. This sublingual formulation of cyclobenzaprine offers a novel mechanism of action, showing statistically significant improvements in pain, sleep disturbance, and fatigue. However, it is not a comprehensive solution, as fibromyalgia remains a complex, heterogeneous condition requiring multimodal care. The approval reflects a broader trend in pain medicine towards non-opioid, mechanism-specific therapies, alongside other innovations like suzetrigine for acute pain.

This Year In Medicine

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

C3G treatment advances in 2025 with FDA approvals of iptacopan and pegcetacoplan, offering disease-modifying options


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C3 Glomerulopathy in 2025: Year in Review

FDA clears first human umbilical cord–derived sheet device, Theracor, for wound Care


FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

In this end-of-year reel, HCPLive has showcased several key highlights from the Skin of Color Savvy podcast in 2025.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

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 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

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Skin of Color Savvy: Highlights from 2025

The FDA grants breakthrough therapy designation for ulizacaltamine for the treatment of essential tremor. 


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FDA Grants Breakthrough Therapy Designation for Ulizacaltamine in Essential Tremor 

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who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

In 2025, psychiatry saw major FDA approvals, novel treatments, and pivotal clinical updates that are transforming care for depression, ADHD, schizophrenia, and anxiety.

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​​Psychiatry in 2025: Year in Review

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

The gastroenterology year in review covers FDA approvals, IBD breakthroughs, IL-23 therapies, new guidelines, and advances in GI care.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Irritable Bowel Syndrome

On the HCPLive irritable bowel syndrome page, resources on the topics of medical news and expert insight into IBS can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBS, IBD, and more.

Ulcerative Colitis

Ulcerative Colitis condition center page, resources on the topics of medical news and expert insight into colitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on UC research, treatment, and drug development.

Gastroenterology in 2025: Year in Review

Catch up on the most impactful headlines in HF from all of 2025 with our Year in Review.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Heart Failure in 2025: Year in Review

The asthma year in review highlights FDA approvals, data, and advances in 2025.

Psoriatic Arthritis

On the HCPLive psoriatic arthritis page, resources on the topics of medical news and expert insight into PsA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on arthritis, and more.

Psoriatic Arthritis in 2025: Year in Review

IgA nephropathy advanced in 2025 with FDA approvals, positive phase 3 trials, and growing disease-modifying therapies


IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

IgA Nephropathy in 2025: Year in Review

New CDC recommendations on hepatitis B vaccination raise concerns over increased infections and healthcare costs, complicating public health efforts.

Infectious Disease

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on viruses, infections, and bacteria. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for COVID-19, influenza, vaccine-preventable diseases, and more.

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