NEW RIVER, SHIRE GET SECOND APPROVABLE LETTER FOR ADHD DRUG

New River Pharmaceuticals and its collaborative partner Shire announced that FDA has issued a second approvable letter for Vyvanse (lisdexamfetamine dimesylate, formerly known as NRP104) for the treatment of attention-deficit/hyperactivity disorder (ADHD).

In October the FDA issued an approvable letter for Vyvanse, and New River submitted a complete response to the agency the same month. In the letter the FDA recommended that Vyvanse receive a Schedule II classification, but the agency didn't request any additional studies of the drug.

The companies said they will work together to provide full and timely responses to the new letter, which requests additional "routine" data, according to the companies' announcement. The development is not expected to delay a launch of Vyvanse in the second quarter of 2007. The Drug Enforcement Agency's (DEA) decision on Vyvanse's scheduling assignment is expected within three months.

Once Vyvanse is approved and receives final scheduling designation by DEA, it will be available in three dosage strengths -- 30, 50 and 70 mg -- all indicated for once-daily dosing.