Axsome Therapeutics Inc on Wednesday announced that the U.S. Food and Drug Administration has granted breakthrough therapy designation to the company’s AXS-05 for the treatment of major depressive disorder (MDD).
The news stoked excitement among investors who pushed shares of the company up 13.74% to $16.31 in premarket trade. AXSM stock is now up more than 467% on a year-over-year basis after several positive updates.
AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. The designation gives Axsome Therapeutics an expedited development and review timeline for AXS-05, which is deemed to significantly improve MDD compared with existing therapies.
According to the National Institute of Mental Health, major depressive disorder affects an estimated one in 15 U.S. adults (6.7%) in any given year. Earlier this year, Axsome Therapeutics reported that AXS-05 met the primary endpoint of a mid-stage study in MDD. The pharma company said that the study resulted in 47% of MDD patients achieving remission by the six-week mark.
Axsome Therapeutics trials have been compared with trial results of Sage Therapeutics Inc. Last week, Sage Therapeutics received marketing approval from the FDA for ZULRESSO injection for the treatment of postpartum depression (PPD). ZULRESSO is the first and only medicine that has been approved by the FDA to treat PPD, the most common medical complication of childbirth.
Axsome Therapeutics CEO Comments
Herriot Tabuteau, MD, Chief Executive Officer of Axsome said, “This Breakthrough Therapy designation from the FDA for AXS-05 in major depressive disorder exemplifies Axsome’s commitment to developing novel medicines that have the potential to significantly improve the lives of patients living with serious CNS disorders.”
Tabuteau added, “There is a significant unmet medical need for new and mechanistically differentiated treatments for depression. We look forward to working closely with the FDA over the coming months to expedite the development of AXS-05 for the treatment of major depressive disorder.”
Axsome Therapeutics Inc Profile
Axsome Therapeutics Inc is a United States-based healthcare service provider. As a pre-clinical therapeutics developer, the company attends primarily to central nervous system disorders such as Alzheimer’s. Its product portfolio consists of novel drugs like the AXS-02 (disodium zoledronate tetrahydrate), which is an oral, non-opioid therapeutic for chronic pain and the AXS-05, which is a fixed-dose combination of dextromethorphan and bupropion.
The AXS-02 addresses pain in over three conditions, such as complex regional pain syndrome, knee osteoarthritis and chronic low back pain. The AXS-05 on the other hand, treats resistant depression and agitation in patients with Alzheimer’s disease. Both the products have passed the preclinical, Phase 1 and Phase 2 stages of development.