Pharmaceutical Business review

FDA delays decision on Cephalon’s ADHD drug

Sparlon is a new formulation and dosage strength of modafinil, the active ingredient in Provigil the company’s already approved treatment for a number of sleep disorders.

The company announced earlier this month that it had submitted new information to the FDA related to a suspected case of Stevens-Johnson syndrome (“SJS”), a rare but serious skin rash condition, in one child participating in a phase III clinical trial.

The new information reflects discussions with the treating physicians, consultation with leading dermatology experts and informal discussions with the FDA. The company formally submitted this new information to the FDA in support of its position that this case is not, in fact, SJS.

“We are very pleased that the FDA has decided to review this new information very carefully, and hope that it will provide a basis for the approval of Sparlon,” said Dr Paul Blake, executive vice president, worldwide medical and regulatory operations. “We anticipate further discussions with the FDA in the coming weeks.”