CEPHALON HALTS DEVELOPMENT OF ADHD DRUG

The FDA has issued a not approvable letter for Cephalon's attention-deficit/hyperactivity disorder (ADHD) drug Sparlon, leading the company to announce it will stop developing the drug altogether.

The company expressed surprise at the agency's decision, which it said was based on a single instance of Stevens Johnson syndrome, an adverse reaction resulting in a severe rash, swelling and sometimes death. Sparlon (modafinil), already sold under the name Provigil for narcolepsy, was the subject of a supplemental new drug application to treat ADHD in children and adolescents.

The drug's rocky history started with an approvable letter last fall. In March, an FDA advisory committee recommended the drug not be approved, saying that while it was effective, it posed "unacceptable risks to children and adolescents." That decision was followed by a three-month extension of the FDA's review period.