Noven Pharmaceuticals announced positive preliminary results from clinical trials of its methylphenidate transdermal system (MTS)…
…which is being developed in conjunction with Shire Pharmaceuticals Group plc for children with Attention Deficit Hyperactivity Disorder (ADHD).
These trial results are expected to be included as part of an amendment to the New Drug Application for the product currently pending at the FDA. Both Noven and Shire believe that the studies will address the issues raised by the FDA’s review in April 2003. The FDA has previously confirmed that the amendment will be reviewed within six months after submission.
The two studies, a Phase 2 study involving 79 patients over a seven-week period and a Phase 3 study involving 268 patients over a seven-week period, examined MTS in children between the ages of 6 and 12 previously diagnosed with ADHD. In these studies, use of MTS was well tolerated and the objectives of both studies were achieved.
Shire is expected to release additional details of the trial results following further analysis and as part of an R&D update in May 2005.
Robert Strauss, Noven’s President, CEO & Chairman, said: “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, Chief Executive Officer of Shire, said: “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 acquired the worldwide sales and marketing rights to MTS from Noven in February 2003.
Methylphenidate Transdermal System
The most common adverse events reported by patients who received the methylphenidate transdermal system in previous clinical trials were: application site reactions such as skin redness, insomnia (difficulty sleeping), anorexia (loss of appetite), headache, abdominal pain, sudden changes in emotions, viral infection (symptoms of a virus), vomiting, weight loss, nervousness, twitching, increased cough, inflammation of the nose, inflammation of the throat, irritability, overall body discomfort, apathy (lack of interest or emotion), fever, anxiety, impaired body movement, and accidental injury.
Preliminary evaluation of adverse events seen in the two trials referenced in this press release included abdominal pain, anorexia (loss of appetite), application site reactions, headache, insomnia, and nausea.
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