Vyvanse receives 2nd FDA approvable letter

UK-based drugmaker Shire and its US partner New River Pharmaceuticals say they have been issued with a second US Food and Drug Administration approvable letter regarding the co-developed attention-deficit hyperactivity disorder treatment Vyvanse (lisdexamfetamine dimesylate). The new document does not request that any new trials are conducted, but does ask for additional data, which the firms describe as routine and not expected to delay the launch of the product, scheduled for the second quarter of the year.

Vyvanse, formerly known as NRP104 is a novel prodrug of dextro-amphetamine designed for smooth absorption and reduced abuse potential. The companies added that the product will be available at three dosage strengths (30mg, 50mg and 70mg) for once-daily dosing.

The FDA's first approvable letter, which was issued late last year (Marketletter October 16, 2006), recommended that the drug should be classified as a Schedule II controlled substance and awarded tentative marketing approval contingent upon a final categorization by the US Drug Enforcement Administration, which is expected by the firms in the next three months.