FDA staff questions Cephalon drug for ADHD
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Some U.S. Food and Drug Administration staff reviewers have raised questions about Cephalon Inc.‘s bid to market its Sparlon drug to treat attention deficit hyperactivity disorder (ADHD), according to documents made public on Wednesday.
The staff reports were released ahead of an FDA advisory panel meeting on Thursday to discuss the new use of the drug, which is already sold as Provigil to treat sleep disorders.
The drugmaker’s shares fell $4.31, or 6 percent, to $67.55 on the Nasdaq in morning trading.
In October 2005, the agency told the company Sparlon could be approved pending certain conditions. But one month earlier, a staff reviewer said the drug carries serious risks and should not be approved for ADHD, according to documents posted on the FDA Web site at http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4212B1-index.htm.
“Despite the demonstration of clinical efficacy, the safety profile demonstrates increased and, in this reviewers opinion, unacceptable risks to children and adolescents,” he said in a memo dated Sept. 26, 2005.
More recently, another reviewer said he was concerned about the incidence of serious skin rashes, including erythema multiforme and Stevens Johnson Syndrome, found in people taking the medicine.
“The incidence… in general is reported to be low, only a few cases per million. Therefore, the finding of a few cases resembling EM/SJS within the population studied is of concern,” FDA medical officer Joseph Porres wrote in a Feb. 27 memo.
Porres said he reviewed data from 933 patients in completed trials and another 533 in an ongoing study as well as post-marketing reports. Six patients appeared to have the serious rashes, another 15 had suggested cases, while 16 appeared to have symptoms but could not be diagnosed.
Cephalon, in other documents released, said its review of clinical studies found a “small increase” of rashes in children and adolescents taking the drug compared to those taking a placebo.
Because of uncertainties diagnosing the skin problems, “the serious nature of the adverse events reported warrant communication of the potential risk through appropriate labeling,” the company said.
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