Shire and New River soar as next-generation ADHD drug gets tentative US approval

US regulators have given tentative approval to a next-generation attention-deficit hyperactivity drug made by UK-based Shire. The Food and Drug Administration issued an approvable letter for NRP104 (lisdexamfetamine dimesylate). Shares in the British drugmaker closed nearly 12% up at L9.80 on the day of the announcement, October 9.

The FDA issued its decision to Shire's collaborator, the USA's New River Pharmaceuticals, giving the go-ahead for its approval as a treatment for pediatric forms of the condition. The agency did not request any additional studies but stated that marketing approval is contingent upon final scheduling by the US Drug Enforcement Administration. The agent is a novel prodrug of dextro-amphetamine designed for smooth absorption and reduced abuse potential.

The FDA has initially proposed that NRP104 be placed in Schedule II of the Controlled Substance Act, which is the same category as Shire's already-marketed ADHD drug Adderrall XR (mixed amphetamine salts). The initial proposal will be submitted to the DEA, which is responsible for making a final scheduling assignment.