Alkermes' shares jump as ALKS 5461 hits main goal of late-stage depression study

Shares in Alkermes jumped as much as 52 percent after the company announced that a Phase III study of ALKS 5461 in patients with major depressive disorder (MDD) met its primary endpoint. Alkermes indicated that based on the data, it plans to request a meeting with the FDA's Division of Psychiatric Products to discuss a filing strategy for the medicine.

The FORWARD-5 trial evaluated the safety, tolerability and efficacy of two dose levels of ALKS 5461 as adjunctive treatment in 407 patients with MDD who had an inadequate response to a stable dose of either a selective serotonin reuptake inhibitor or a serotonin-norepinephrine reuptake inhibitor.

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The company noted that top-line results showed that treatment with the higher dose of ALKS 5461 significantly reduced symptoms of depression compared to placebo, as measured by 6-item Montgomery–Åsberg Depression Rating Scale (MADRS-6) scores. The higher dose of Alkermes' drug also demonstrated significant reductions in 10-item MADRS scores compared to placebo. The drugmaker added that although the lower dose of ALKS 5461 showed improvement in depressive symptoms, it did not separate significantly from placebo.

According to Alkermes, the most commonly reported adverse events for ALKS 5461 were nausea, dizziness and fatigue. The company added that it will present detailed findings from the study at an upcoming medical meeting.

In January, Alkermes announced that two Phase III studies of ALKS 5461 for the adjunctive treatment of MDD in patients who have an inadequate response to standard therapies for clinical depression failed to meet their primary endpoints.

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