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Axsome’s Auvelity Receives the US FDA’s Approval for the Treatment of Major Depressive Disorder

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Axsome’s Auvelity Receives the US FDA’s Approval for the Treatment of Major Depressive Disorder

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  • The US FDA has approved Auvelity (dextromethorphan HBr -bupropion HCl) ER tablets for MDD. The therapy is expected to be available in the US in the Q4’22
  • The approval was based on the P-III (GEMINI) trial to assess Auvelity in 327 patients which showed significant superiority in improving symptoms of depression over PBO, change in MADRS total score from baseline was significant at 1 & 2wk.
  • In (ASCEND) study, the therapy was superior to bupropion sustained-release tablets (105mg, BID). The company launched the patient support program i.e., Auvelity On My Side which provides access to patients to use Auvelity & also offers patient support services, incl. the Auvelity On My Side savings card for eligible commercially-insured patients

Ref: Globenewswire | Image: Axsome

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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