Shire's new stick-on drug patch for hyperactive children is too dangerous to allow on the market, according to one of the leading scientists at the US medical regulator, the Food & Drug Administration.
The recommendation, in a briefing note to the panel that will consider Shire's launch application today, suggests the FTSE 100 drug maker will face an uphill struggle in gaining approval for the product.
While the company insisted yesterday that a negative vote by the panel was not a foregone conclusion, its shares slipped. The patch, called Daytrana, is one of six products due to be launched by Shire next year, as it assembles a portfolio of drugs to replace its lead hyperactivity treatment, Adderall, which is expected to face copycat competition in 2006.
If Shire fails to get approval for the patch, it will be the second time the FDA has knocked back the product. The company suggested the patch be worn for nine, rather than the originally planned 12 hours, but Robert Levin, the FDA clinician who has reviewed the new data, says he maintains his original concerns.
Briefing notes for the panel of experts - whose recommendations are usually followed by the FDA - include Dr Levin's conclusion that "treatment with [Daytrana] was associated with a high incidence of insomnia, anorexia or decreased appetite, headache and gastrointestinal symptoms including vomiting, nausea and upper abdominal pain. These events were significantly more common in the [Daytrana] group than in the active comparator group (Concerta) and the placebo group".
Shire's scientists are hoping the FDA is split on the safety of Daytrana and that the panel will be swayed by doctors' views that the product represents an important alternative for six-12 year olds who have difficulty taking tablets. Shire shares fell 4.5p to 704p, one of the few in the FTSE 100 to fall yesterday.Reuse content