Cephalon Drug Conditionally Approved

The FDA delays making a final decision on the sleep-disorders drug Nuvigil.
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Cephalon

(CEPH)

was hit with a setback Monday when the Food and Drug Administration delayed making a final decision on the sleep-disorders drug Nuvigil.

The FDA granted conditional approval of Nuvigil, a cousin of the company's best-selling drug Provigil, another drug for sleep problems. Final approval is contingent on the company and the agency agreeing on the wording of a label, Cephalon said.

Label discussions can take a few weeks to a few months. However, the discussions for Nuvigil may take extra time because they are affected by the ongoing FDA review of another Cephalon drug, Sparlon, for attention deficit hyperactivity disorder. Sparlon is a high-dose version of Provigil.

In March, an FDA advisory panel of medical experts

voted 12-1 against Sparlon, telling the agency that more safety tests were needed. The agency doesn't have to follow its advisers' recommendations, but it usually does.

The panel was concerned about a clinical trial of Sparlon in which one child apparently contracted a rare, often dangerous skin rash called Stevens-Johnson syndrome.

The panel's comments caused Cephalon's stock to plunge, but the company recently submitted additional data to the FDA maintaining that the child

didn't suffer from Stevens-Johnson syndrome. The FDA agreed to extend its review of Sparlon until Aug. 22, rather than make a decision on May 22.

Cephalon said "the FDA indicated that the outcome of its review of this new

Sparlon information will be addressed directly in the label for Nuvigil."

"We are working closely with the FDA to move this application to an approval and expand our offering of wake-promotion choices for patients," said Paul Blake, a Cephalon executive vice president, in a prepared statement.

The announcement came after the markets had closed. In regular trading, Cephalon closed at $65.68, up 2 cents. After hours, the stock gained 32 cents.

Cephalon is seeking FDA approval of Nuvigil for treating excessive sleepiness due to the neurological disease narcolepsy; for obstructive sleep apnea/hypopnea syndrome, in which a person repeatedly stops breathing or experiences shallow breathing for short periods of time; and for shift-work sleep disorder, which affects people who can't get used to constantly changing work hours. Provigil is prescribed for all three problems.