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http://www.businessweek.com/ap/2013-10-10/alkermes-depression-drug-gets-fast-track-status

AP News

Alkermes depression drug gets fast track status


NEW YORK (AP) — Irish drugmaker Alkermes said Thursday that the Food and Drug Administration is awarding fast track status to its experimental depression treatment ALKS 5461.

Fast-track status is intended to speed up the development and regulatory process, and it gives companies extra meetings and correspondence with regulators throughout the review process. Alkermes will be allowed to submit clinical data on ALKS 5461 as it compiles it.

Drugs are given fast track status if regulators determine that they are major improvements in treatment or if the drug is a potential treatment for a condition with no therapeutic options.

The company said the drug is a new treatment for major depressive disorder, a diagnosis that means an individual has a list of severe depression symptoms, potentially including thoughts of suicide or a suicide plan.

Alkermes PLC makes the addiction treatment Vivitrol.

Its shares rose $1.30, or 4.3 percent, to $31.47 in morning trading.


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