Cephalon has responded to an FDA committee's rejection of Sparlon--its experimental therapy for ADHD--by submitting new information that it believes could pave the way to approval. In a filing to the SEC on Tuesday, Cephalon said that it had notified the FDA that the skin ailment suffered by a patient in its clinical trial of Sparlon did not appear to be Stephens-Johnson syndrome.
An FDA advisory committee voted last month to recommend against Sparlon and said the drug developer needed to develop more safety data. That vote was based on fears of the suspected case of Stephens-Johnson syndrome, an adverse effect associated with drug reactions. The FDA is expected to make a formal decision on Sparlon by May 22.
- here's the report on Cephalon from TheStreet.com