In this video, Christoph U. Correll, MD, discusses additional research needed on the combination of olanzapine and the mu-opioid antagonist samidorphan. Dr. Correll is Professor of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.
The olanzapine/samidorphan combination, also known as ALKS 3831, is being evaluated by the US Food and Drug Administration. Alkermes is seeking approval of the investigational drug for the treatment of both schizophrenia and bipolar disorder. A study on ALKS 3831, which Dr. Correll co-authored, was presented at Psych Congress 2019.
Read the transcript:
Other studies are needed. These include the ENLIGHTEN- Early study that is ongoing that takes, not patients 18 to 55 with lots of years of antipsychotic exposure, but rather, early phase patients with no more than a year of antipsychotic exposure and the subgroup no more of 3 months, where we would expect that olanzapine causes a lot of weight gain, and also, the metabolic signal would be larger. In order to see whether, again, samidorphan added to olanzapine could potentially mitigate that signal even stronger and be significant, not only on reduction of weight gain or patients gaining weight at a certain amount, but also less insulin resistance, glucose elevation, and also lipid abnormalities.