Pfizer Inc. (NYSE: PFE) today announced that Quillivant XR™ (methylphenidate hydrochloride) CII for extended-release oral suspension is now available in the U.S. for the treatment of attention deficit hyperactivity disorder (ADHD). Quillivant XR is the first once-daily, extended-release liquid methylphenidate for ADHD and is now available by prescription.
"In order to effectively treat patients with chronic conditions such as ADHD, it is important to consider individual patient needs, including options for medication administration," said Ann Childress, M.D., president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, who was an investigator in the Quillivant XR laboratory classroom study. "As the first once-daily, extended-release liquid medication for patients with ADHD, Quillivant XR represents a new alternative to other ADHD treatments."
Quillivant XR was approved by the U.S. Food and Drug Administration (FDA) on September 27, 2012 for the treatment of ADHD in patients aged 6 years and above. The efficacy of Quillivant XR was evaluated in a randomized, double-blind, placebo-controlled, crossover, multicenter, laboratory classroom study of 45 children with ADHD. 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.
ADHD is one of the most common neurobehavioral disorders in the U.S. According to the Centers for Disease Control and Prevention's 2007 data, about one in ten children aged 4 - 17 in the U.S. had at any time in their life received a diagnosis of ADHD. Patients with ADHD may suffer from symptoms such as difficulty paying attention, impulsivity and being overly active in some cases. The condition can last into adulthood. Although there are many treatment options for ADHD, until Quillivant XR there was no once-daily, extended-release liquid option for the treatment of this condition.
"Pfizer is pleased to provide patients and their caregivers with a new option to help manage this challenging condition," said Sam Azoulay, M.D., senior vice president of medical and development for Pfizer's Emerging Markets and Established Products Business Units. "We also recognize that caring for and treating a child with ADHD goes beyond medication. We look forward to working with mothers and other caregivers of children with ADHD to provide meaningful resources to the ADHD community."
Pfizer acquired NextWave Pharmaceuticals on November 27, 2012. Quillivant XR was developed in conjunction with NextWave's manufacturing partner, Tris Pharma, using Tris Pharma's patent-protected drug delivery platform. For more information, please visit www.quillivantxr.com.
Pfizer plans to offer Quillivant XR to patients in need through our Pfizer Helpful Answers® program. Pfizer Helpful Answers is Pfizer's family of patient-assistance programs that helps eligible patients in the U.S. in need get access to their Pfizer medicines. In 2011, Pfizer Helpful Answers helped more than 1 million patients receive over 7.8 million Pfizer prescriptions through our programs.