BioXcel Therapeutics Inc.'s BXCL501 has been granted fast-track designation by the U.S. Food and Drug Administration to treat irritability and restlessness due to medical and psychiatric conditions.
BXCL501 is BioXcel Therapeutics' proprietary film of dexmedetomidine that is placed under the tongue to treat acute agitation. Patients with severe acute agitation are unable to control their behavior.
The FDA's fast-track status facilitates the development and expedites review of new drugs and vaccines that have a potential to fulfill an unmet medical need.
BioXcel Therapeutics expects topline results from its phase 1 study of BXCL501, which is evaluating the safety and absorption of the drug, in the first half of 2019.
New Haven, Conn.-based BioXcel Therapeutics develops novel drugs using intelligence and is working to identifying the next wave of medicines across neuroscience and immuno-oncology.