ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) said in a SEC filing that it expects to complete enrolment in its Phase 3 efficacy, tolerability and safety trial with pimavanserin for Parkinson’s disease psychosis, during August 2012. Data is expected later in 4Q 2012.
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) confirmed the PDUFA date for SPN-804 (extended-release oxcarbazepine) for epilepsy, is October 19, 2012. It also mentioned that its product Trokendi (formerly known as SPN-538) which had been given tentative approval from the FDA, will not be given final approval until the period of exclusivity protection associated with paediatric patients, age 1-24 months, expires on June 22, 2013. As a result the company now expects to launch Trokendi in 3Q 2013.
GlaxoSmithKline plc (GSK) and Theravance, Inc. (Nasdaq:THRX) today announced the submission of NDA and MAA filings in the US and European Union for the once-daily investigational medicine fluticasone furoate “FF”/vilanterol “VI” (FF/VI) for patients with chronic obstructive pulmonary disease (COPD) and a MAA filing for asthma in the European Union. For asthma, GSK and Theravance are reviewing the strategy for a future US filing.