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 schizophrenia: 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.1

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 8.2 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.1 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.”

References

1. 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/. Accessed April 21, 2025.

2. 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. Accessed April 21, 2025.