Alkermes depression drug
succeeds in key trial; shares surge
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[October 21, 2016]
(Reuters) - Alkermes Plc's
experimental depression drug significantly reduced symptoms in patients
suffering from major depressive disorder who were not helped by standard
treatments in a pivotal late-stage trial, the company said on Thursday,
and its shares surged 47 percent.
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The results marked a reversal of fortune for the drug, which had
failed to achieve efficacy goals in two earlier Phase III trials
announced in January, casting serious doubt on the program.
In the 407-patient trial, the drug, ALKS 5461, significantly reduced
symptoms of depression compared with a placebo, according to initial
results released by the company.
Based on the results of this third Phase III trial, Alkermes said it
plans to speak with U.S. health regulators about the next steps
toward seeking approval.
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At the time of the failure of the drug in the two earlier Phase III
trials, the company said it believed that success in the third Phase
III study, called Forward-5, could still lead to a path to approval.
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.
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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
were nausea, dizziness and fatigue, consistent with what had been
seen in earlier trials, the company said.
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 Leslie Adler)
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