Cephalon Inc. was counting on an FDA advisory panel to recommend the approval of its drug, Sparlon, The panel, however, did not agree with CephalonÃ¢â‚¬â„¢s position that the drugÃ¢â‚¬â„¢s effectiveness as a treatment for attention deficit hyperactivity disorder (ADHD) outweighed its potential risks.
While the independent panel of outside experts did not have a problem with the effectiveness of the drug, it was troubled by the paucity of data with respect to concerns that Sparlon presented a risk of causing the serious and sometimes fatal skin condition known as Stevens-Johnson Syndrome (SJS).Ã‚Â Ã‚Â Ã‚Â Ã‚Â
Ã‚Â Sparlon is currently sold in a lower dose as Provigil to treat sleep disorders.Ã‚Â
It was the panelÃ¢â‚¬â„¢s opinion that Cephalon do additional testing in order to determine the extent to which SJS is an actual risk to children and adolescents who would be taking the drug.Ã‚Â
In the general population, SJS occurs at a rate of 1/100,000 to 1/1,000,000. The data collected so far with respect to Sparlon suggests an SJS incidence rate of 1/1,000, which would be unacceptably high if borne out by additional clinical trials.
In most cases, the FDA follows the recommendations of its advisory panels and there is no reason to believe it would approve Sparlon now that the panel has failed to endorse such a disposition of CephalonÃ¢â‚¬â„¢s application.
The FDA had requested the panel review specifically over the SJS issue since its database of adverse reactions disclosed three reports of SJS among Provigil users to go along with one case in the Sparlon trial.
The FDAÃ¢â‚¬â„¢s director of its office of drug evaluation suggested a study involving at least 3,000 participants would be needed and would have to result in zero new cases of SJS in order to bring the drug within acceptable risk limits.