Phase III depression trial success for Alkermes

pharmafile | October 24, 2016 | News story | Research and Development, Sales and Marketing ALKS 5461, Alkermes, major depressive disorder 

Biopharma company Alkermes has announced the success of its ALKS 5461 treatment in a Phase III study for the treatment of major depressive disorder (MDD), which met its primary endpoint and sent shares rocketing as much as 52%.

The success follows the company’s previous failure in two Phase III trials of the drug in January.

The 407-person trial investigated the safety, efficacy and tolerability of two doses of the drug in MDD sufferers who had not responded to a stable dose of either a selective serotonin reuptake inhibitor or a serotonin-norepinephrine reuptake inhibitor. According to the 6-item Montgomery–Åsberg Depression Rating Scale (MADRS-6), ALKS 5461 was found to significantly reduce symptoms compared to placebo; furthermore, the higher dose of the drug was shown to significantly reduce 10-item MADRS scores. The lower dose could not differentiate itself from placebo.

The company is due to present detailed findings of the study at an upcoming medical meeting. The company now intends to meet with the FDA’s Division of Psychiatric Products to discuss a filing strategy for ALKS 5461.

Matt Fellows

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