Company Overview of NextWave Pharmaceuticals, Inc.
NextWave Pharmaceuticals, Inc., a specialty pharmaceutical company, focuses on the development and commercialization of products for the treatment of central nervous system (CNS) and attention deficit hyperactivity disorder (ADHD). Its product pipeline includes NWP06, a methylphenidate extended-release oral suspension that is in Phase III clinical stage for the treatment of ADHD; NWP09, which are methylphenidate extended-release chewable tablets that are in Phase I clinical stage for the treatment of ADHD; and NWP08, which are clonidine extended-release chewable tablets that are in Phase I clinical stage for the treatment of CNS. NextWave Pharmaceuticals, Inc. was formerly known as Children ...
20450 Stevens Creek Boulevard
Cupertino, CA 95014
Founded in 2005
Key Executives for NextWave Pharmaceuticals, Inc.
Chief Financial Officer and Senior Vice President
Executive Vice President and President of OTC Business
Chief Business Officer and Senior Vice President
Vice President of Business Development
Compensation as of Fiscal Year 2013.
NextWave Pharmaceuticals, Inc. Key Developments
NextWave Pharmaceuticals, Inc. Receives FDA Approval of Quillivant XR(TM) for Once-Daily Treatment of ADHD
Oct 1 12
NextWave Pharmaceuticals announced FDA approval of Quillivant XR(TM) for extended-release oral suspension, CII. Quillivant XR is approved for the treatment of Attention Deficit Hyperactivity Disorder. Quillivant XR is the first once-daily, extended-release liquid methylphenidate available for patients with ADHD. The approval of Quillivant XR fills a void that has long existed in the treatment of ADHD. The efficacy of Quillivant XR was evaluated in a randomized, double-blind, placebo-controlled, crossover, multicenter, laboratory classroom study of 45 children with ADHD. There was an open-label dose optimization period with an initial 20mg dose of Quillivant XR once daily in the morning. The dose was titrated weekly in 10 or 20mg increments until an optimal dose or maximum dose of 60mg per day was reached. Patients then entered a two-week double-blind, crossover treatment of the individually optimized dose of Quillivant XR or placebo. At the end of each week, trained observers evaluated the attention and behavior of the patients in a laboratory classroom using the SKAMP rating scale. Quillivant XR significantly improved ADHD symptoms compared to placebo at the primary endpoint of four hours post-dose, and in a secondary analysis, showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing. Quillivant XR is expected to become available in pharmacies in January 2013. Quillivant XR was developed using Tris Pharma's patent protected drug delivery platform.
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