Phase 3 Study of Novel, Once-Daily, Antipsychotic Drug Candidate for Schizophrenia Interview with:

Jelena Kunovac, M.D., M.S. Founder and Chief Executive Chief Medical Officer Altea Research Las Vegas, Nevada

Dr. Kunovac

Jelena Kunovac, M.D., M.S.
Founder and Chief Executive
Chief Medical Officer
Altea Research
Las Vegas, Nevada 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. 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 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 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.



The information on is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.


Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.