Alkermes (ALKS) initiated two of the three core efficacy phase III studies (FORWARD-3 and FORWARD-4) on ALKS 5461 under its FORWARD (Focused On Results With A Rethinking of Depression) program. ALKS 5461 is being developed for the adjunctive treatment of major depressive disorder (MDD).
FORWARD comprises three core phase III efficacy studies and nine supportive studies to evaluate the long-term safety, dosing, pharmacokinetic profile and abuse potential of ALKS 5461. Four of the 12 FORWARD studies have already begun. The third core phase III study, FORWARD-5, is also expected to be initiated soon.
The FORWARD-3 and FORWARD-4 studies will be evaluating the safety and efficacy of ALKS 5461 in patients who did not respond satisfactorily to currently available therapies, including selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. The efficacy studies will primarily assess the change in Montgomery–Åsberg Depression Rating Scale scores from baseline in these patients.
Results from the FORWARD-3 and FORWARD-4 studies are expected in 2016. Alkermes intends to utilize the data from the FORWARD program to form the basis of its New Drug Application (:NDA) submission for ALKS 5461 in the MDD indication in the U.S.
We are encouraged by Alkermes’ progress with its pipeline. The company has a series of pipeline events lined up in the quarters to come. Candidates like aripiprazole lauroxil and ALKS 3831, both for schizophrenia, hold promise. Positive news on the pipeline will boost the stock.
Alkermes, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Gilead Sciences Inc. (GILD), Regeneron Pharmaceuticals, Inc. (REGN) and Alexion Pharmaceuticals, Inc. (ALXN). While Gilead and Regeneron carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).