Alkermes boosted by positive Ph II data on ALKS 5461 for major depressive disorder

Ireland-headquartered Alkermes (Nasdaq: ALKS) saw its shares rise 16% to $29.72, after it announced positive preliminary top-line results from a Phase II study of ALKS 5461, its novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. ALKS 5461 reflects a new approach to the treatment of MDD based on modulation of opioid receptors in the brain and is designed as a non-addictive, oral, once-daily medicine, the company noted.

Data from the study showed that ALKS 5461 significantly reduced depressive symptoms across a range of standard measures including the study’s primary outcome measure, the Hamilton Depression Rating Scale (HAM-D17) (p=0.026), the Montgomery-Asberg Depression Rating Scale (MADRS) (p=0.004) and the Clinical Global Impression – Severity Scale (CGI-S) (p=0.035). ALKS 5461 was generally well tolerated.

Based on these results, as well as the positive Phase I/II results previously reported, Alkermes plans to request a meeting with the US Food and Drug Administration and advance ALKS 5461 into a pivotal development program. Data from this Phase II study will be presented at the Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Hollywood, Florida, May 28-31, 2013. “Based on the strength of these data, as well as the positive results seen in the prior clinical study, we will move forward rapidly to meet with the FDA and initiate a pivotal development program with a goal of bringing this important new medication to patients with MDD,” stated Elliot Ehrich, chief medical officer of Alkermes.