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 News

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.

Data Readouts

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.

Features/Podcasts

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.

References

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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