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Will Alkermes Data Package Support ALKS 5461 Approval?

 
• By Mandy Jackson

Alkermes revealed successful completion of its third Phase III trial for the depression drug ALKS 5461 as well as a risky plan to seek FDA approval based on two negative and one positive late-stage study.

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Alkermes PLC is betting that the novel design of its Phase III clinical trials, including the recently positive FORWARD-5 trial and two previously failed studied, and its overall data package will be enough to convince the FDA to approve its depression drug ALKS 5461 – a risky approach in a tough indication.

The company’s first two Phase III trials (FORWARD-3 and FORWARD-4) did not show a significant benefit versus placebo as an...

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