New River Pharmaceuticals Inc. and its collaborative partner Shire plc have announced that the US Food and Drug Administration (FDA) has issued a second approvable letter for Vyvanse (lisdexamfetamine dimesylate, formerly known as NRP104) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
On October 6, 2006 the FDA issued an approvable letter for Vyvanse and New River Pharmaceuticals submitted a complete response to the FDA on October 24, 2006.
No additional studies have been requested by the FDA as a condition for approval of Vyvanse. The companies will work together to provide full and timely responses to the agency's request. The data requested are routine, and their provision to the FDA is not expected to delay a launch of Vyvanse in the second quarter of 2007. The US Drug Enforcement Administration's parallel review of Vyvanse's scheduling assignment is expected within three months.
The FDA has proposed that Vyvanse be classified as a Schedule II controlled substance. This proposal has been submitted to the US Drug Enforcement Administration (DEA). Once Vyvanse is approved by the FDA and receives final scheduling designation by DEA, Vyvanse will be available in three dosage strengths- 30 mg, 50 mg and 70 mg, all indicated for once daily dosing.
In January 2005, New River Pharmaceuticals signed a collaborative agreement with Shire to develop and commercialize Vyvanse. Details on the collaboration agreement are available in previous filings with the US Securities and Exchange Commission.
New River Pharmaceuticals Inc. is a specialty pharmaceutical company developing novel pharmaceuticals that are generational improvements of widely prescribed drugs in large and growing markets.
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.