MTS was well tolerated in two studies involving patients diagnosed with ADHD. A Phase two trial included 79 patients and a Phase three trial included 238 patients, between 6 -12 years of age. These trials address issues raised by the FDA's review in 2003 and will most likely be included in as part of an amendment to the New Drug Application filed with the FDA.
Robert Strauss, Noven's President, CEO & Chairman, stated: "Today's news is an important step forward in the development of our methylphenidate patch. The next step is preparation of an amendment to the pending New Drug Application, and we expect to be working closely with our partner Shire to achieve that goal."
Matthew Emmens, CEO of Shire, stated: "These results demonstrate that MTS has the potential to provide significant benefits for children with ADHD, especially those that have difficulty taking oral medications and those that find a once-a-day patch more appropriate for their lifestyle. As the ADHD market develops, new choices of treatment are emerging, including specialized delivery systems (such as MTS) to meet the needs of different patients. Shire aims to have a range of medicines in its ADHD portfolio, with ADDERALL XR® being the most prescribed treatment for ADHD in the U.S. If approved, this product will be a strong addition and we look forward to advancing its development further." Shire is expected to release additional details of the trial results as part of an R&D update in May 2005.Shire Pharmaceuticals Group plc is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system, gastrointestinal, and renal diseases. Shire acquired the worldwide sales and marketing rights to MTS from Noven in February 2003.
Noven Pharmaceuticals, Inc. is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products.