Strong results for Alkermes' ALKS 5461 in major depressive disorder

US drugmaker Alkermes (Nasdaq: ALKS) yesterday released positive early clinical results for a central nervous system (CNS) drug candidate, ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, and accelerated next steps for clinical trials with this novel compound.

When considered along with news issued recently that Alkermes initiated a Phase III clinical study with another proprietary CNS candidate, ALKS 9070 for schizophrenia (a once-monthly version of Abilify; aripiprazole, from Bristol-Myers Squibb and Otsuka), this progress shows how Alkermes is moving forward as a key player in the CNS space following the completed merger with Elan Drug Technologies (The Pharma Letter September 19, 2011).

In the Phase I/II clinical study, ALKS 5461 was shown to significantly reduce depressive symptoms, as measured by the Hamilton Depression Rating Scale (HAM-D17; a standard, clinician-assessed measure of depression severity), in patients with MDD who received ALKS 5461 for the seven-day treatment period. In addition, data from the study showed that ALKS 5461 was generally well tolerated. ALKS 5461 is the combination of ALKS 33, a proprietary opioid modulator, and buprenorphine. Based on these results, Alkermes has accelerated the start of the phase 2 study of ALKS 5461 for MDD, which has initiated.