ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in neurological and related central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to NUPLAZID™ (pimavanserin) for the treatment of Parkinson’s disease psychosis. NUPLAZID is a selective serotonin inverse agonist and, if approved, will establish a new and distinctly different pharmacological approach to treating psychosis. NUPLAZID has successfully completed a pivotal Phase III trial in Parkinson’s disease psychosis, which the FDA has agreed can serve as the basis, together with supportive data from other studies, for a New Drug Application (NDA). ACADIA plans to submit the NUPLAZID NDA to the FDA near the end of this year.
Rotterdam, 02/09/2014-INC News (via ANSA AP)
No comments:
Post a Comment