The first once-daily liquid drug for Attention Deficit Hyperactivity Disorder (ADHD), Quillivant XR, has been approved by the US Food and Drug Administration (FDA).
Quillivant XR, developed by NextWave Pharmaceuticals in conjunction with Tris Pharma, is an extended-release oral suspension drug intended for ADHD suffers who struggle to swallow pills.
Centre for Psychiatry and Behavioral Medicine, Las Vegas, president and investigator Dr Ann Childress said; "The approval of Quillivant XR fills a void that has long existed in the treatment of ADHD."
"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," Childress added.
Quillivant XR was tested in a randomised double-blind, placebo-controlled, crossover, multicenter, laboratory classroom study of 45 children with ADHD.
Patients were given an open-label dose for four to six weeks, followed by a 20mg dose every morning. The does was then titrated weekly in 10mg or 20mg additions, up to a maximum dose of 60mg per day.
This was followed by a two-week double blind, crossover treatment of the individually optimised dose of Quillivant XR or placebo.
Trained observers evaluated patient’s attention and behaviour at the end of every week in a laboratory classroom, using the SKAMP (Swanson, Kotkin, Agler, M-Flynn and Pelham) rating scale.
The trial discovered that Quillivant XR significantly improved the patients symptoms compared to the placebo at the primary endpoint of four hours post-dose.
NextWave Pharmaceuticals president and CEO Jay Shepard said; "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."
ADHD is one of the most common neurobehavioral disorders in the United States and is believed to affect between 5% and 10% of schoolchildren in the UK.
It is characterised by symptoms such as difficulty paying attention, impulsive behavior and, in some cases, patients being overly active.