Shire plc announced that its collaborative partner New River Pharmaceuticals Inc. has received an approvable letter from the US Food and Drug Administration (FDA) for NRP104 (lisdexamfetamine dimesylate), for the treatment of paediatric Attention-Deficit/Hyperactivity Disorder (ADHD).
This result is generally consistent with historical responses from FDA following their review of New Drug Applications for ADHD medications. According to the FDA's letter, marketing approval of NRP104 is contingent upon final scheduling by the U.S. Drug Enforcement Administration (DEA). The FDA as a condition for approval of NRP104 has requested no additional studies. Shire and New River will continue dialog with FDA officials to agree upon a final trade name. Shire and New River Pharmaceuticals are preparing for a product launch in Q2 2007, pending final labelling and scheduling discussions.
The Controlled Substance Staff of the FDA has initially proposed that NRP104 be placed in Schedule II of the Controlled Substance Act. The initial proposal will be submitted to the DEA, which is responsible for making a final scheduling assignment. Shire anticipates timely resolution of this process. Once FDA approves NRP104 and the schedule designation is issued by DEA, NRP104 will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-a-day dosing.
"This approvable letter for NRP104 is positive news for Shire and our partner New River Pharmaceuticals," said Shire Chief Executive Officer Matthew Emmens. "Following approval, NRP104 is expected to offer patients, their families, and healthcare providers an important new treatment for ADHD. As a company specializing in the treatment of ADHD, we have a wide range of medications for this condition currently marketed or under development, including the most prescribed brand of ADHD medication, ADDERALL XR. Once approved, we look forward to adding NRP104 to the Shire portfolio."