Axsome Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for AXS-02 for the treatment of pain associated with complex regional pain syndrome (CRPS). AXS-02 is an oral, non-opioid, potentially first-in-class pain therapeutic being developed by Axsome for the treatment of chronic pain caused by CRPS.

CRPS is a debilitating condition characterized by severe pain in a limb, accompanied by autonomic, sensory, motor and trophic changes. For many patients, the pain and associated loss of function result in significant and sometimes permanent disability. There is currently no drug approved to treat this orphan condition in either the United States or the European Union.

"We are pleased that the FDA has granted Fast Track status for AXS-02 for the treatment of pain associated with CRPS, as it demonstrates their recognition of this condition as a significant unmet medical need," said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. "Our product's Fast Track designation status, in addition to Orphan Drug designations from both the FDA and EMA [European Medicines Agency], provide significant regulatory confirmation as we work to bring our therapy to those suffering from this serious condition."

For more details, go to: http://globenewswire.com/news-release/2015/03/05/712700/10123413/en/Axsome-Therapeutics-Announces-FDA-Fast-Track-Designation-for-AXS-02-for-the-Treatment-of-Pain-Associated-With-Complex-Regional-Pain-Syndrome.html