Attention deficit hyperactivity disorders (ADHD) is now a common diagnosis with the U.S. Center for Disease Control and Prevention estimating that almost one in ten (9.5 percent) children aged 4-17, has at some time, received a diagnosis of ADHD.
Common treatment strategies for ADHD include cognitive-behavioral therapy and pharmaceuticals. The Food and Drug Administration has now approved Quillivant XR (methylphenidate hydrochloride), the first once-daily, extended-release liquid methylphenidate available for patients with ADHD.
The new medication is a welcome addition to traditional medication regimens as authorities say that in 2011, there were more than 52 million prescriptions filled for ADHD medications, representing a 10 percent increase over 2010.
“The approval of Quillivant XR fills a void that has long existed in the treatment of ADHD,” 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.
“We routinely see the struggles of patients who have difficulty swallowing pills or capsules. Having the option of a once-daily liquid will help alleviate some of these issues while still providing the proven efficacy of methylphenidate for 12 hours after dosing.”
Researchers determined the efficacy of Quillivant XR by performing a randomized, double-blind, placebo-controlled study of 45 children with ADHD.
For the study children received an initial 20mg dose of Quillivant XR once daily in the morning. The dosage was then titrated weekly until an optimal dose or maximum dose of 60mg per day was reached.
After this, a two-week double-blind study was performed on the study using a crossover design (meaning that kids would alternate between receiving the medication or a placebo.
At the end of each week, trained observers evaluated the attention and behavior of the patients in a laboratory classroom using an established behavioral 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.
“We are pleased with the FDA’s approval of Quillivant XR and believe it will address an important need for many patients with ADHD and their caregivers,” said Jay Shepard, President and CEO of NextWave Pharmaceuticals.
“We are eager to enter into the ADHD market and believe the unique liquid formulation of Quillivant XR—which was developed in conjunction with NextWave’s technology and manufacturing partner Tris Pharma—will provide another treatment option for patients with ADHD.”
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.
Source: New Wave Pharmaceuticals