FDA APPROVES SHIRE, NEW RIVER'S VYVANSE FOR ADHD

Shire and its collaborative partner New River Pharmaceuticals announced that the FDA has approved Vyvanse (lisdexamfetamine dimesylate) for the treatment of attention-deficit/hyperactivity disorder (ADHD).

The companies also recently announced an agreement whereby Shire will acquire New River for approximately $2.6 billion in an all-cash transaction.

Vyvanse is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, Vyvanse provided significant efficacy compared with placebo for a full treatment day. Furthermore, when the drug was administered orally and intravenously in two clinical drug abuse studies, Vyvanse produced subjective responses on a scale of drug-liking effects that were less than d-amphetamine at equivalent doses.

The FDA has proposed that Vyvanse be classified as a Schedule II controlled substance. This proposal was submitted to and accepted by the Drug Enforcement Administration. A final scheduling decision is expected following a 30-day period for public comment. Once Vyvanse receives final scheduling designation, the label will be available. The companies plan to launch the product in the second quarter. The drug will be available in three dosage strengths: 30, 50 and 70 mg, all indicated for once-daily dosing.

The companies received two FDA approvable letters before receiving final approval for Vyvanse.