Axsome Therapeutics Receives FDA’s Orphan Drug Designation for AXS-12 (reboxetine) to Treat Narcolepsy

Shots:

• The US FDA’s ODD may enable Axsome a seven years of marketing exclusivity in the US, with incentives and reduction in user fees of product required for PDUFA act
• In Q4’18, Axsome plans for onset of P-II trial of AXS-12 for the treatment of symptoms of narcolepsy with expected results in H1’19
• AXS-12 is a novel, PO norepinephrine reuptake inhibitor indicated for Narcolepsy. Additionally, Axsome has four clinical-stage candidates, AXS-05, AXS-07, AXS-09, and AXS-12 indicated in various neurological disorder

Click here to read full press release/ article | Ref: Axsome Therapeutics | Image: RTE