Cephalon Drug May Be Delayed

The FDA wouldn't approve Sparlon because of a report about one child in a clinical trial experiencing a suspected rare skin disease called Stevens-Johnson syndrome. The condition, caused by a reaction to some drugs, can be fatal.

Cephalon officials investigated the matter and sent information to the FDA, concluding that the child had a virus-induced rash. They also provided reports by the child's doctors and consultants who reviewed medical records and photos. They said the child was never hospitalized and didn't miss any school.

While Cephalon was appealing the Sparlon case, the agency also was reviewing Nuvigil. On May 1, the FDA gave conditional approval to the drug, but held off on final clearance until an agreement could be reached on what the Nuvigil label would say.

Although the medication's approval may be delayed, "we see this as an important opportunity to ensure that the final label for Nuvigil reflects the actual medical condition of this child," said Dr. Lesley Russell, a Cephalon executive.

Cephalon wants Nuvigil approved for several sleep disorders, including the neurological disease narcolepsy and shift-work sleep disorder, which affects people who can't get used to constantly changing work hours.

In about three years, Cephalon will begin encouraging patients to switch to Nuvigil from its cousin Provigil, the company's best-seller. Strategically, Cephalon wants patients using Nuvigil before generic copies of Provigil hit the market.

Provigil also contains modafinil. The current label says post-marketing accounts have included "rare reports of serious skin reactions," including Stevens-Johnson syndrome.

Because alleged side effects are reported voluntarily "from a population of uncertain size," the label says "it is not always possible" to assess cause-and-effect or the frequency of side effects. A revised Provigil label will include the same information that's delaying FDA approval of Nuvigil.

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