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Alkermes Depression Drug Fails to Meet Trial Goals

Update Date: Jan 21, 2016 09:32 AM EST

Alkermes Plc stated on Thursday that its drug has failed to meet the trial goals in two late stage studies. Company shares for premarket trading have dipped 32 percent.

The drug, ALKS 5461, which is supposed to treat major depressive disorder, has failed to improve patients' symptoms. In the first study, the researchers had recruited 385 patients to test to effects of two dosages, which were 2 mg and 0.5 mg. Both of the dosages were not any more effective at alleviating the symptoms of depression in comparison to a placebo. Patients took the drug orally once a day.

In the second study, the researchers examined the effects of the drug on 429 patients. This time, however, they found that the placebo had a greater effect on depressive symptoms than the drug. Alkermes concluded that the drug failed to meet the primary endpoints in both of the Phase 3 trials.

"Clinical trials of new medicines for the treatment of major depressive disorder are complicated by significant placebo response," Elliot Ehrich, the chief medical officer at Alkermes, said. "We recognize that this is a challenging disease state where multiple clinical studies and expansive analyses are generally necessary to confirm the efficacy of a new medicine."

Patients from both groups did not respond to other standard treatment options for clinical depression prior to joining the studies. The team measured depression using the Montgomery-Åsberg Depression Rating Scale (MADRS).

Alkermes will now focus on its ongoing third trial, which also includes two dosages of ALKS 5461. The company stated that based on the results from the first two studies, they will be increasing the number of patients enrolled in the trial. An update on this study is expected before the end of the quarter.

About 17 million people live with major depressive disorder in the United States.

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