31 Oct Phase 3 Study of Novel, Once-Daily, Antipsychotic Drug Candidate for Schizophrenia
MedicalResearch.com Interview with:
Jelena Kunovac, M.D., M.S.
Founder and Chief Executive
Chief Medical Officer
Las Vegas, Nevada
MedicalResearch.com: What is the background for this study?
Response: We conducted the study to confirm that the addition of samidorphan to olanzapine does not have an effect on the antipsychotic efficacy of olanzapine in subjects with an acute exacerbation of schizophrenia.
MedicalResearch.com: What are the main findings?
The primary endpoint was change from baseline in PANSS Total score and CGI-S compared to placebo.
- ALKS 3831 demonstrated greater antipsychotic efficacy compared with placebo, as measured by the PANSS and CGI-S scales
- The efficacy of ALKS 3831 and OLZ were similar
MedicalResearch.com: What should readers take away from your report?
Response: The addition of samidorphan does not affect the antipsychotic efficacy of olanzapine in patients with an acute exacerbation of schizophrenia
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: There are ongoing clinical trials designed to further characterize ALKS 3831 in patients with schizophrenia.
Disclosures: Dr. Kunovac was an investigator on this study and reports both research grants and consulting for Alkermes. In addition, Dr. Kunovac has received research grants and consultation honoraria from Acadia, Allergan, Astelas, Auspex, Axsome, Daichhi, Intracellular Therapeutics, Lundback, Nektar Therapeutics, Neurocrine, Otsuka, Sunovion, Synerex and Tonix.
Potkin SG, et al. A phase 3 study to determine the antipsychotic efficacy and safety of ALKS 3831 in adult patients with acute exacerbation of schizophrenia. Presented at: Psych Congress; Oct. 25-28, 2018; Orlando, Fla.
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