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Alkermes Depression Drug Hits Important Goal in Late-Stage Study

By Ryan Bushey | October 24, 2016

Alkermes saw its shares surge on Thursday after the Dublin, Ireland-based company announced new trial data regarding its experimental drug to treat major depressive disorder, ALKS 5461.

Initial results from a randomized Phase 3 study featuring 407 patients had shown ALKS 5461 was able to significantly improve depression symptoms in patients who had an inadequate response to other standard therapies, wrote The Wall Street Journal.

ALKS 5461 is a once-daily pill treatment designed to act as a neuromodulator. It’s comprised of samidorphan and buprenorphine, which is a combination of drugs that helps rebalance brain function that becomes dysregulated in the state of depression.

The lower dose of the drug did not achieve statistical significance when compared to placebo whereas the two tested higher doses of ALKS 5461 outperformed placebo on two different depression scales, according to Reuters. Some adverse events were reported like nausea and fatigue although this was consistent with occurrences in previous studies.

These results signify a turnaround after the company had to cancel two Phase 3 trials earlier this year after the drug failed to meet its primary endpoints.

Alkermes stock rose 43 percent in after-hours trading on Thursday adding more than $3 billion to the company’s market value, explained WSJ.


Filed Under: Drug Discovery

 

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