Shire Pharmaceuticals, alongside partner Noven, yesterday re-filed its ADHD patch in the USA, but investors appeared little interested and neither companies’ share prices saw much movement.
Shire and Noven were forced to re-evaluate the future of their methylphenidate patch, then called Methypatch, when the US Food and Drug Administration issued a not-approvable letter in 2003 citing clinical and other issues [[29/04/03b]]. The news battered both firms’ stock, and pushed back the expected launch date from the second half of 2003.
MTS, as the product is now called, is designed for the once-daily treatment of attention deficit hyperactivity disorder in children aged 6-12 years and involves the transdermal delivery of medication throughout the day. The new submission includes data from a Phase III study including 270 ADHD patients and a 79-patient Phase II trial, both of which were conducted over a seven-week period. Results showed that MTS was well tolerated and efficacious, with the primary endpoint met. However, the FDA will likely be scrutinising the product’s side effect profile, which in this trial included decreased appetite, sleeplessness, twitching, weight loss, nausea and vomiting.
Shire is hoping it will add to its already powerful presence this area with Adderall and Adderall XR (amphetamine salts), both of which are facing generic threats [[25/07/05e]], [[20/07/05g]]. The FDA has already granted MTS a six-month review, meaning a launch could take place early next year if a green light is awarded.