ST. PETERSBURG, FLORIDA | Cognitive Research Corporation (CRC) partnered with BioXcel Therapeutics on FDA approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. This program was from first-in-human trials through NDA approval. With this approval, BioXcel becomes the first and only FDA-approved orally dissolving sublingual film for mild, moderate, or severe agitation in patients with schizophrenia or bipolar disorder. Tom Hochadel, President of CRC, commented, “It is very rare for a clinical service company to work with a sponsor from first-in-human to NDA approval of a new drug. CRC and BioXcel have been collaborating on this program since 2018 and have worked cohesively and rapidly to move this innovative new therapy to approval. CRC is proud of their ability to deliver scientific and clinical development expertise to this program.”
Read more details here.