Positive results from Alkermes’ ALKS 5461 phase 1/2 study on MDD

Alkermes plc (NASDAQ: ALKS) today presented positive results from the phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, in an oral session at the 52^nd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Phoenix.    

In the phase 1/2 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 buprenorphine and ALKS 33, a proprietary opioid modulator.

"We are delighted to present these results to experts in the mental health community at the NCDEU meeting showing that ALKS 5461 offers potential as a novel treatment for patients with MDD who have inadequate response to antidepressant therapy. Our study showed a rapid onset of action and clinically meaningful reduction in depressive symptoms after only seven days of treatment with ALKS 5461, which is very encouraging and prompted us to accelerate initiation of our phase 2 study," stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "ALKS 5461, one of several product candidates in our advancing clinical pipeline, is an excellent example of how Alkermes is leveraging our unique understanding of opioid biology and pharmacology to develop medications that address unmet medical needs for central nervous system disorders."

Based on the positive results of the phase 1/2 study, a phase 2 study of ALKS 5461 was initiated in January 2012 to further evaluate the utility of ALKS 5461 in treating MDD. The phase 2 trial is a randomized, double-blind, multicenter, placebo-controlled study that will evaluate the efficacy and safety of ALKS 5461 when administered once daily for four weeks in approximately 130 patients with MDD who have inadequate response to antidepressant therapy. Data from the study are expected in the first half of calendar 2013.