Topline results for ALKS 5461 in depression- Alkermes

Alkermes has announced topline results from FORWARD-1, one of a series of supportive clinical studies in the comprehensive FORWARD Phase III pivotal program for ALKS 5461 (samidorphan + anor.), for the adjunctive treatment of Major Depressive Disorder (MDD). The FORWARD-1 study was designed to evaluate the safety and tolerability of two titration schedules of ALKS 5461. In addition, the study assessed the efficacy of ALKS 5461 over an eight-week period, compared to baseline, in patients with MDD. Data from the 66-patient study showed that ALKS 5461 was generally well tolerated in both of the two titration schedules evaluated – one-week and two-week dose escalation schedules. The most common adverse events in the study were nausea, constipation and dry mouth.

These findings were consistent with the safety and tolerability profile seen in the 142-patient Phase II study completed in 2013. Additionally, the exploratory efficacy analyses showed that ALKS 5461 significantly reduced depressive symptoms from baseline starting at Week One and continued to the end of the treatment period at Week Eight in patients who received either of the two titration schedules. The observed changes from baseline were clinically meaningful and statistically significant (p<0.001). These data support the one-week titration schedule being utilized in the core Phase III efficacy studies in the FORWARD program.