Alkermes plc (NASDAQ: ALKS) today announced positive topline results from a 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 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 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.
"The rapid onset of effect observed in patients treated with ALKS 5461 in this study is very encouraging. Specifically, patients who had experienced an inadequate response to previous antidepressant therapy showed a meaningful reduction in depressive symptoms after only seven days of treatment with ALKS 5461," stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "We are so encouraged by these data that we have already begun a phase 2 clinical study for ALKS 5461 to further evaluate its utility in treating MDD."
This phase 1/2 multicenter, randomized, double-blind, placebo-controlled, parallel-group study was designed to evaluate the safety and tolerability and explore the efficacy of ALKS 5461 compared to placebo in 32 patients with MDD who had an inadequate response to a stable dose of either a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI). Patients received one of two sublingual dosing regimens of ALKS 5461 or placebo for seven days. In both dosing cohorts, patients administered ALKS 5461 demonstrated greater reductions from baseline in depressive symptoms, as measured by the HAM-D17, compared to those administered placebo. In one dosing cohort, these differences in depressive severity were statistically significant as measured by the HAM-D17. ALKS 5461 was generally well tolerated in both dosing cohorts.
The newly initiated 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.