ALKS 5461: Additional Phase II data

Alkermes said additional data from a double-blind, U.S. Phase II trial in 142 patients with MDD showed that the once-daily low dose (2 mg ALKS 33 and 2 mg buprenorphine) of oral ALKS 5461 as adjunctive treatment was more effective than the once-daily high dose (8 mg ALKS 33 and 8 mg buprenorphine) of oral ALKS 5461. Specifically, low-dose ALKS 5461 significantly reduced HAM-D17 scores from baseline to week 4, the primary endpoint, by 5.3 points vs. 1.2 points for placebo (p=0.013). Low-dose ALKS 5461 also significantly reduced MADRS scores from baseline to week 4, a secondary endpoint, by 8.7 points vs. 1.8 points for placebo (p=0.004). High-dose ALKS 5461 reduced HAM-D17 scores by 3.6 points and MADRS scores by 5 points. The trial enrolled 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). Data were presented at the New Clinical Drug Evaluation Unit meeting in Hollywood, Fla. Based on the results, Alkermes said the low dose of ALKS 5461 will be the top end of the dose range used in future trials of the product. ...