Andrew Cutler, MD

TEV ‘749 Survey Shows Many Nurses Prefer Intramuscular Injections, with Andrew Cutler, MD

Teva Pharmaceuticals announced new TEV- ‘749 data on March 31, 2025, finding that more than 90% of patients, 87% of nurses, and 73% of physicians reported satisfaction about the initiation regimen, monthly dosing schedule, and dosing options of this once-monthly subcutaneous olanzapine long-acting injectable (LAI) for schizophrenia.

The survey was conducted via the phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS), an 8-week, randomized (1:1:1), double-blind, placebo-controlled trial evaluating TEV- ‘749. These findings followed other promising SOLARIS data, including the statistically significant mean differences in the Positive and Negative Syndrome Scale (PANSS) total score from baseline, as well as the improvements in social functioning and quality of life.

HCPLive spoke with SOLARIS investigator Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University and chief medical officer at Neuroscience Education Institute, about Teva’s prospective, cross-sectional, observational, online study completed by 70 patients, 11 physicians, and 24 nurses who reported their attitudes on and experiences with LAI treatment, delivery of care, and treatment satisfaction. Cutler discussed the drivers behind the 

, unexpected findings, and what are the next steps for advancing TEV- ‘749 toward regulatory approval.

“One of the things that was a little surprising was there were some of the doctors and some of the nurses who actually didn't prefer subcutaneous—they felt more comfortable with an intramuscular injection,” Cutler said. “Some of that is simply their familiarity with intramuscular. They trust it. They know it can work, and they maybe haven't quite yet had enough experience with a subcutaneous delivery to trust it and to feel it was going to be as effective.”

The survey revealed 50% and 45.5% of nurses and physicians preferred intramuscular injections, respectively, opposed to most patients preferring a subcutaneous injection (78.6%).

Cutler explained how certain patient populations may benefit the most from TEV- ‘749, including those who do not adhere to their current treatments. Often, LAIs are not offered to patients until later in their treatment regimen, after they have had multiple relapses. However, as Cutler said, frequent relapses damage the brain and decrease function; Cutler suggests offering these patients LAIs after failing to adhere to 1 or 2 oral medications.

He said the steps for research is studying long-term safety in a certain number of patients to prove TEV- ‘749 is not associated with a risk of Post-Injection Delirium/Sedation Syndrome (PDSS). Cutler added that, until the discovery of new mechanisms of action, the most effective way to maximize an anti-psychotic class’s potential is to use an LAI.

“Sometimes you haven't seen the magic of an LAI until you've seen a consistent therapeutic blood level over time, and the really best way—maybe only way to deliver that—is through a long-acting injection,” Cutler said. “I think we have a lot of work to do on convincing clinicians of the value of LAIs to and overcome some of the barriers to LAI usage, which can include all kinds of things like the formulation, the initiation regimen… [and] some systemic issues.”

New Data Strengthens Teva’s Schizophrenia Portfolio, Including Phase 3 SOLARIS Trial Survey Results Demonstrating Patient and Healthcare Professional Satisfaction with TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable. Teva. March 31, 2025. 

https://www.tevausa.com/news-and-media/press-releases/new-data-strengthens-tevas-schizophrenia-portfolio-including-phase-3-solaris-trial-survey-results-demon/

Derman, C. Phase 3 Data Shows TEV-‘749 Injection Improves Social Function in Schizophrenia. HCPLive. November 6, 2024. 

https://www.hcplive.com/view/phase-3-data-shows-tev--749-injection-improves-social-function-in-schizophrenia

Derman, C. TEV- ‘749 Once-Monthly LAI Yields High Satisfaction in Phase 3 Trial, with Andrew J. Cutler, MD. HCPLive. April 21, 2025. 

https://www.hcplive.com/view/tev--749-once-monthly-lai-yields-high-satisfaction-in-phase-3-trial-with-andrew-j-cutler-md

Articles

Teva Pharmaceuticals' TEV-‘749, a once-monthly subcutaneous olanzapine long-acting injectable (LAI) for schizophrenia, demonstrated high satisfaction among patients, nurses, and physicians in the phase 3 SOLARIS trial. Despite some healthcare professionals' preference for intramuscular injections, patients favored subcutaneous delivery. The study highlighted the potential benefits of LAIs for patients with adherence issues, suggesting earlier intervention could prevent relapses. Future research will focus on long-term safety and addressing barriers to LAI adoption, emphasizing the importance of consistent therapeutic blood levels for maximizing antipsychotic efficacy.

Cutler told HCPLive it was surprising that a new survey on subcutaneous TEV- ‘749 revealed 50% and 45.5% of nurses and physicians, respectively, preferred intramuscular injections.


TEV- ‘749 Once-Monthly LAI Yields High Satisfaction in Phase 3 Trial, with Andrew J. Cutler, MD

On March 31, 2025, Teva Pharmaceuticals announced more positive data on TEV- ‘749, a once-monthly subcutaneous olanzapine long-acting injectable (LAI) for 

: more than 92% of patients, 87% of nurses, and 73% of physicians reported being satisfied or very satisfied about TEV- ‘749’s initiation regimen, monthly dosing schedule, and dosing options.

The attitudes and experiences survey was conducted within the successful Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS), an 8-week, randomized (1:1:1 ratio), double-blind, placebo-controlled trial evaluating TEV- ‘749.

Teva had previously announced other promising data from SOLARIS, sharing that the trial met its primary endpoint of statistically significant mean differences in the change in the change in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 8.

 The company also shared a different time that TEV-’749 significantly improved the social functioning and quality of life in adults with schizophrenia.

HCPLive spoke with SOLARIS investigator Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University and chief medical officer at Neuroscience Education Institute, about Teva’s prospective, cross-sectional, observational, online study completed by 70 patients, 11 physicians, and 24 nurses who answered questions about their attitudes on and experiences with LAI treatment, delivery of care, and treatment satisfaction.

 Cutler discussed what distinguishes TEV- ‘749 from current long-acting injectable antipsychotics, the drivers behind its high satisfaction, and the implications of TEV- ‘749 being able to mitigate the risk of Post-Injection Delirium/Sedation Syndrome (PDSS).

Cutler explained how current LAI medications consist of 2 basic molecules—risperidone and aripiprazole. There is also paliperidone, but Cutler said that is essentially the same as risperidone since it is an active metabolite of that drug.

“Another…important aspect of this medication is that it's a third different molecule because not every patient responds well or tolerates all medicines,” Cutler said. “It's nice to have another option that some people may do especially well with.”

The survey found physicians slightly preferred subcutaneous over intramuscular injections (54.6% vs 45.5%), and the preference was split evenly for nurses (50% vs 50%). Patients heavily preferred a subcutaneous vs intramuscular injection (78.6% vs 21.4%), with 67.3% of patients citing needle size for their preference.

“It's subcutaneous, so it's a smaller needle, and most of us have had a subcutaneous injection,” Cutler said. “Maybe we've had a vaccination, a flu shot, or something like that. Also, insulin is delivered by subcutaneous injection…a lot of the patients said that they preferred the subcutaneous [because] it was less scary.”

Videos

HCPLive spoke with Cutler on recent phase 3 SOLARIS data and what distinguishes TEV-‘749 from other long-acting injectables.

Unmet Needs, Future Research in Schizophrenia and Muscarinic Agonists

xanomeline and tropsium chloride capsules (Cobenfy, formerly KarXT)

, signals a transformative shift in psychopharmacology, ushering in what leading subject matter experts are calling the "third wave" of drug development. Historically, the field has evolved from the introduction of tricyclic antidepressants and typical antipsychotics in the 1950s to the atypical antipsychotics of the 1980s, which focused on improved tolerability and safety.

As Andrew Cutler, MD, notes in the segment, this new generation leverages innovative mechanisms—particularly targeting acetylcholine alongside dopamine—aiming to address the heterogeneous nature of schizophrenia. With a range of muscarinic agonists in development, there is hope for better management of cognitive impairments and negative symptoms that have long been inadequately treated.

“We're entering an era that I'm calling the ‘muscarinic wars’ right now, which is like the old atypical wars that I lived through before Rishi entered the field, probably in the 90s, when we had a number of these atypicals,” Cutler said. “It was terrific because they're all different. Some patients we know do better with one than another, and I think the same will hold true here.”

Rishi Kakar, MD, echoed this same sentiment—noting, in his 15 years conducting studies, he has noticed more enthusiasm among clinicians with the paradigm shift.

“Let's ride the wave and see where we go,” said Kakar, on entering this new era in management.

Mechanism of Action of Xanomeline and Trospium Chloride Capsules

Applying EMERGENT Trial Results to Real-World Clinical Practice for Schizophrenia

Balancing the Benefits and Risks of Xanomeline and Trospium Chloride Capsules

(Moderator) is a former practicing psychiatrist and is the founder and chief executive officer of Terran Biosciences.

is a clinical associate professor in the Department of Psychiatry and Behavioral Sciences at SUNY Upstate Medical University and the chief medical officer of the Neuroscience Education Institute.

is a psychiatrist based out of southern Florida as well as the medical director and chief scientific officer of Segal Trials. Kakar served as the principal investigator on the pivotal EMERGENT trials.

Relevant disclosures for Cutler include Karuna, Bristol Myers Squibb, and 

. Relevant disclosures for Kakar include Karuna, Bristol Myers Squibb, and others. Relevant disclosures for Clark include Terran Biosciences.

The approval of new schizophrenia treatments, such as xanomeline and tropsium chloride capsules, marks a significant advancement in psychopharmacology, heralding a "third wave" of drug development. This new generation of treatments targets acetylcholine alongside dopamine, aiming to address cognitive impairments and negative symptoms inadequately treated by previous medications. Experts like Andrew Cutler and Rishi Kakar highlight the potential for diverse patient responses, similar to the "atypical wars" of the 1990s. The enthusiasm among clinicians suggests a promising future for schizophrenia management.

In part 5 of 5, experts discuss ongoing unmet needs and future research priorities in schizophrenia management.

In this segment of our latest HCPLive Special Report on the 

recent approval of xanomeline and tropism chloride capsules (Cobenfy)

, conversation shifts to the critical issue of medication adherence in patients with schizophrenia. Research has indicated that adherence rates for oral medications have dropped below 50%. Rishi Kakar, MD, lead investigator of the EMERGENT trials, opened the conversation by emphasizing the multifaceted reasons behind nonadherence, highlighting that medication frequency, tolerability, and caregiver perspectives play significant roles.

Andrew Cutler, MD, expanded on the topic, explaining that factors such as inadequate efficacy, intolerable adverse events, and anosognosia can contribute to low adherence rates in patients with mental illness.

The conversation also touched on the advantages of long-acting injectable (LAI) antipsychotics, which are increasingly being adopted in clinical practice. Cutler and Kakar discuss the benefits of LAIs in terms of convenience and improved tolerability, especially for patients who struggle with daily medication reminders. They acknowledge the potential for new muscarinic agonists to be developed into LAIs, while also stressing the importance of maintaining oral medication options for patients who may not prefer injectables.

The discussion centers on the challenges of medication adherence in schizophrenia, with adherence rates for oral medications falling below 50%. Factors such as medication frequency, tolerability, and caregiver perspectives are highlighted as contributing to nonadherence. Long-acting injectable (LAI) antipsychotics are presented as a beneficial alternative, offering convenience and improved tolerability. The potential for developing new muscarinic agonists into LAIs is acknowledged, while maintaining oral options for those who prefer them. The conversation involves experts with relevant disclosures from pharmaceutical companies.

In part 4 of 5, experts discuss medication adherence to schizophrenia treatments, particularly of xanomeline and trospium choloride capsules for schizophrenia.