September 20, 2014 4:13 AM ET

Pharmaceuticals

Company Overview of NextWave Pharmaceuticals Incorporated

Company Overview

NextWave Pharmaceuticals Incorporated develops and commercializes pharmaceutical 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 for the treatment of ADHD; NWP09, which are methylphenidate extended-release chewable tablets for the treatment of ADHD; and NWP08, which are clonidine extended-release chewable tablets that for the treatment of CNS. The company was formerly known as Children We Care Pharmaceuticals, Inc. The company was incorporated in 2005 and is based in Cupertino, California. As of November 27, 2012, NextWave Pharmaceuticals Inc...

20450 Stevens Creek Boulevard

Suite 150

Cupertino, CA 95014

United States

Founded in 2005

Phone:

408-342-1300

Fax:

408-342-1400

Key Executives for NextWave Pharmaceuticals Incorporated

Vice President of Clinical Affairs
Vice President of Sales and Marketing
Compensation as of Fiscal Year 2014.

NextWave Pharmaceuticals Incorporated Key Developments

NextWave Pharmaceuticals, Inc. Receives FDA Approval of Quillivant XR(TM) for Once-Daily Treatment of ADHD

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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