21 October 2016 - - Irish pharmaceutical company Alkermes plc (NASDAQ: ALKS) has announced positive topline results from FORWARD-5, the third phase 3 efficacy study to read out from the FORWARD pivotal programme for ALKS 5461, the company said.

ALKS 5461 is a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies.

According to Alkermes, the study met its prespecified primary endpoint showing treatment with ALKS 5461 significantly reduced symptoms of depression in patients with MDD compared to placebo. ALKS 5461 was generally well tolerated.

The most common adverse events observed for ALKS 5461 were nausea, dizziness and fatigue.

Based on these results, along with the substantial data collected to date on the efficacy and safety of ALKS 5461 for the treatment of MDD, the company plans to request a meeting with the US Food and Drug Administration's Division of Psychiatric Products to discuss the filing strategy for this Fast Track designated medicine.

In the study, ALKS 5461 2mg/2mg met the prespecified primary endpoint of significantly reducing depression scores compared to placebo, as measured by six-item Montgomery–Åsberg Depression Rating Scale (MADRS-6) scores.

ALKS 5461 2mg/2mg also demonstrated statistically significant reductions in ten-item MADRS (MADRS-10) scores compared to placebo.

The 1mg/1mg dose of ALKS 5461 showed improvement in depressive symptoms in the study, but did not separate significantly from placebo.