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