Alkermes – This recommended biotech stock has delivered the goods with outstanding positive topline data in a treatment for depressions, explains leading biotech analyst John McCamant, editor of The Medical Technology Stock Letter.
Alkermes reported these positive results for what is known as FORWARD-5, the third Phase III trial to read out from the FORWARD pivotal program for ALKS 5461.
This is a once-daily, oral compound for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.
The trial 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 FDA’s Division of Psychiatric Products to discuss the filing strategy for this Fast Track designated medicine.