Alkermes's Partner J&J Files sNDA for Bipolar Disorder Drug
Posted on: Friday, 25 July 2008, 12:01 CDT
Alkermes has announced that its partner, Johnson & Johnson Pharmaceutical Research & Development submitted a supplemental new drug application for Risperdal Consta to the FDA for approval as monotherapy in the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in adults.
The Risperdal Consta uses Alkermes's proprietary Medisorb technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. Available in 12.5mg, 25mg, 37.5mg and 50mg dose units, Risperdal Consta is approved for the treatment of schizophrenia.
Risperdal Consta is marketed by Janssen, division of Ortho-McNeil-Janssen Pharmaceuticals in the US and is manufactured by Alkermes.
Elliot Ehrich, chief medical officer of Alkermes, said: "The approval of Risperdal Consta for the maintenance treatment of bipolar I disorder would bring patients and their physicians a novel and valuable treatment option for managing this serious, chronic disease."
Source: Datamonitor
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