Shire Pharmaceuticals took a step closer to bringing its patch product to treat attention deficit hyperactivity disorder to the US market after a US Food and Drug Administration advisory committee voted to approve the product, albeit with some reservations.
Daytrana (methylphenidate) has been designed as an alternative to oral products in the once-daily treatment of ADHD in children aged six to 12 years. It has had to navigate a number of twists and turns on its route to market, and the FDA advisory committee vote was by no means a shoe in.
Ahead of the meeting, the FDA staffer in charge of the review said he did not believe the product should be approved, because its safety profile was not as good as already-available oral methylphenidate products, such as Johnson & Johnson’s Concerta. But he reversed his position during the course of the meeting, saying that with the exception of skin sensitization the side effect profile of Daytrana was similar to oral products.
The panellists said the product should be approved, and crucially stopped short of restricting use of the product to second-line therapy after a patient had already tried oral methylphenidate treatment to control their ADHD symptoms, suggesting instead that oral treatment should be considered first. They also rejected by 11 votes to one a motion to restrict use of the patch to patients who could not tolerate oral methylphenidate products.
Warning about the skin sensitization side effect, including the potential to render patients sensitive to oral methylphenidate products, should be included in the labeling for Daytrana, said the committee, which also called for post-marketing surveillance to keep an eye on the product’s safety profile.
A decision from the FDA on Daytrana is due to be announced on or before December 28.
Daytrana is one of six new products Shire is hoping to launch next year to help it weather the loss of marketing exclusivity on Adderall XR (mixed amphetamine salts), its top-selling product.