FDA releases Sparlon documents

FDA briefing documents suggest that discussion at Thursday's meeting of FDA's Psychopharmacologic Drugs Advisory Committee will likely focus on the risk of serious skin rashes and other adverse events associated with Sparlon modafinil from Cephalon (CEPH) to treat ADHD in children and adolescents. Specifically, FDA will ask the panel what type of risk management plan should be implemented to address the risk of skin rashes, how the risk should be addressed in the label and whether post-marketing studies should be required.

In an October approvable letter posted to FDA's website on Wednesday, the agency raised concerns about reports of serious rash, psychiatric adverse events and transaminase elevations in clinical trials. The letter highlighted three cases of "clinically important" rash among 933 patients who received Sparlon in three Phase III trials, including one case of Stevens-Johnson syndrome (SJS). The letter noted that even a single case of SJS, a potentially life-threatening reaction, was of concern and that the agency was aware of five reports of either erythema multiforme or SJS in adults treated with modafinil. CEPH submitted a response to the letter in November. ...