The company is developing ALKS 5461, a once-daily, oral medicine to treat major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression.
The first two of three phase 3 studies, Forward-4 and Forward-3, did not meet the prespecified primary efficacy endpoint, when ALKS 5461 was compared to a placebo.
However, Alkermes said there was a clear trend towards efficacy in one of the dose levels in the Forward-4 study.
The company said based on these analyses, it believes that Forward-4 offers supportive data of ALKS 5461’s efficacy in the treatment of MDD.
Alkermes is also undertaking third phase 3 study, Forward-5. The company plans to increase patient enrollment and update statistical analysis depending on results from the earlier two studies. An update on the study is anticipated later this quarter.
Alkermes chief medical officer Elliot Ehrich said: "Clinical trials of new medicines for the treatment of major depressive disorder are complicated by significant placebo response.
"We designed the Forward pivotal program to include three efficacy studies as we recognize that this is a challenging disease state where multiple clinical studies and expansive analyses are generally necessary to confirm the efficacy of a new medicine."
ALKS 5461, which features samidorphan and buprenorphine, acts as a balanced neuromodulator in the brain and represents a novel mechanism of action to treat MDD.