FDA Extends Review of Cephalon Drug

The agency wants three more months to consider Sparlon for ADHD.
Author:
Publish date:

Cephalon

(CEPH)

said the Food and Drug Administration has extended by three months its review of the company's experimental drug for attention deficit hyperactivity disorder.

The FDA will act by Aug. 22 instead of May 22, Cephalon said.

Cepahlon viewed the delay as favorable because it will give the agency more time to analyze the drug, Sparlon, and the controversy over a clinical trial in which one child was thought to have contracted a rare, dangerous skin disease. Because of that case, an FDA advisory committee

voted 12-1 against the drug four weeks ago.

The panel said Cephalon should conduct more safety tests. The one "yes" vote came from a dermatologist.

Last week, Cephalon

provided more information about the suspected side effect known as Stevens-Johnson syndrome. The company said its research supports its belief that the skin rash suffered by the child wasn't Stevens-Johnson.

"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 Paul Blake, executive vice president for worldwide medical and regulatory operations.

Cephalon announced the FDA's decision after the markets closed. In regular trading, Cephalon's stock closed up 62 cents to $66.21. After hours, it gained another 73 cents.