Gained rights last November as part of NextWave acquisition
Pfizer launched its first attention-deficit hyperactivity disorder (ADHD) drug Quillivant XR onto the market in the US, taking on a sector currently dominated by Shire.
Quillivant XR is the first once-daily, extended-release liquid methylphenidate for ADHD and fills a gap in the current marketplace for drugs to treat the condition, said the pharma company. It was approved last September by the FDA to treat ADHD in patients aged 6 years and above.
The efficacy of Quillivant XR was evaluated in a randomized, double-blind, placebo-controlled, crossover, multicentre, laboratory classroom study of 45 children with ADHD.
The drug significantly improved ADHD symptoms compared to placebo at the primary endpoint of four hours post-dose, and in a secondary analysis, it showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing.
"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, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas.
Quillivant XR has a child-friendly formulation that provides an extended treatment effect and so avoids any need for dosing during the school day.
Pfizer acquired Quillivant XR as part of its purchase of NextWave Pharmaceuticals last November in a deal which included upfront payments of $255m - on top of an earlier $20m option fee - and up to $425m in sales milestones.
The price tag reflects the fact that the ADHD market is worth around $4bn a year with growth outstripping the overall pharma market, thanks to the success of products such as Shire's Daytrana (methylphenidate; now divested to Noven), Vyvanse (lisdexamfetamine) and Intuniv (guanfacine), as well as Johnson & Johnson's Concerta (methylphenidate).
Some analysts have questioned the appetite of the sector for additional premium-priced products however, now that generic versions of older ADHD drugs such as Shire's Adderall XR (mixed amphetamine salts) are available.
In addition to Quillivant XR, NextWave is developing a chewable tablet formulation of methylphenidate – known as NWP09 - that is due to be filed for approval later this year.