- A six-month Phase 2 study evaluating Alkermes' (NASDAQ:ALKS) investigational oral atypical antipsychotic drug candidate, ALKS 3831, showed a durable efficacy compared to olanzapine as well as favorable effects on weight gain compared to olanzapine.
- The trial was conducted in two stages. In the initial three months, patients were randomized to receive either olanzapine or one of three doses of ALKS 3831. Antipsychotic efficacy and weight gain were assessed. Positive top-line data were reported in January. For the second three-month stage, patients receiving olanzapine were switched to ALKS 3831 while those already on ALKS 3831 continued therapy. Data from the second stage showed that switching from olanzapine for ALKS 3831 stopped mean weight gain.
- ALKS 3831 demonstrated equivalent efficacy to olanzapine in patients receiving ALKS 3831 for the entire six-month period as measured by Positive and Negative Syndrome Scale (PANSS) total scores while the mean percent change in body weight from Week 12 to Week 24 was only 0.5%. The mean change in body weight in patients receiving olanzapine during the first three months was 4.3% but only changed 0.1% during the subsequent three months after transitioning to ALKS 3831.
- Alkermes intends to submit the results for publication in a peer-reviewed journal. It plans to advance ALKS 3831 to Phase 3 development later this year.
- Olanzapine, sold under the brand name Zyprexa, generated more than $1B in sales for manufacturer Eli Lilly (NYSE:LLY) the past four quarters.
- Previously: Alkermes antipsychotic successful minimizing weight gain in Phase 2 study (Jan. 7)