Alkermes depression drug succeeds in key trial, shares surge

Alkermes Plc on Thursday said its lead depression drug met the main goal of a pivotal late-stage trial in patients not helped by standard antidepressants, and the company’s shares surged 47 percent.

In the 407-patient trial, the drug, ALKS 5461, significantly reduced symptoms of depression in patients suffering from major depressive disorder compared with a placebo, according to initial results released by the company.

Based on the results of a third successful Phase III trial, Alkermes said it plans to speak with U.S. health regulators about the next steps toward seeking approval.

While the drug demonstrated clear superiority over placebo on two different depression scales at the higher of two tested doses, the lower dose did not achieve significance compared with placebo, the company said.

The most commonly reported side effects for ALKS 5461 in the study, called Forward-5, were nausea, dizziness and fatigue, consistent with what had been seen in earlier trials, the company said.

ALKS 5461, a once-daily pill combining samidorphan and buprenorphine, is designed to rebalance brain function that becomes dysregulated in the state of depression.

“We designed ALKS 5461 to have a novel mechanism of action for the treatment of major depressive disorder, a serious disease where new therapeutic options are highly sought after as millions of patients in the U.S. do not respond to standard courses of antidepressant therapy,” Alkermes’ chief medical officer, Elliot Ehrich, said in a statement.

Alkermes shares jumped to $64 in after hours trading from a Nasdaq close at $43.51.

(Reporting by Bill Berkrot in New York and Shailesh Kuber in Bangaluru; Editing by Don Sebastian and Leslie Adler)