Final approved labeling for Cephalon's Nuvigil (armodafinil) will likely include results of an FDA safety review for the firm's other pending product, attention deficit/hyperactivity disorder treatment Sparlon (modafinil).

Cephalon received an "approvable" letter April 28 for armodafinil, the follow-on to Provigil (modafinil). Provigil is marketed for the promotion of wakefulness and the company is also seeking an additional indication for ADHD under the trade name Sparlon.

The application for armodafinil is for the treatment of "excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder," the firm said. FDA previously extended the Nuvigil user fee date by three months to April 30 (¹ Also see "Cephalon’s Nuvigil User-Fee Date Extended" - Pink Sheet, 1 February, 2006.).

The agency has expressed concerns regarding dermatological skin reactions associated with use of modafinil, including one possible case of Stevens John Syndrome identified in Sparlon clinical trials.

"In its Nuvigil approvable letter, the FDA indicated that the outcome of its review of this new information will be addressed directly in the label for Nuvigil," Cephalon said.

FDA's Psychopharmacologic Drugs Advisory Committee met March 23 to review Sparlon and largely agreed that additional safety information should be required before approval of modafinil for treatment of ADHD.

FDA extended Sparlon's user fee date to Aug. 22 in order to review additional safety data submitted by Cephalon (² Also see "Sparlon User Fee Date Extended To August" - Pink Sheet, 24 April, 2006.).

"We've got convincing evidence now" that this was not a case of SJS, Cephalon Exec VP - Medical & Regulatory Operations Paul Blake said during the firm's May 2 earnings call.

Based on FDA's concerns, Nugivil approval does not seem likely before the end of August. Cephalon's settlements with generic challengers to Progivil give the firm plenty of time to transition to the follow-on, although those deals must still be cleared by the Federal Trade Commission (³ Also see "Unsettling Settlements: FTC Alarmed By Increasing Brand/Generic Deals" - Pink Sheet, 24 April, 2006.).

Labeling discussions appear to be the only remaining barrier to approval for Nuvigil, the company noted.

Cephalon said that it will meet with FDA "very shortly" to discuss what the agency will require for final approval. Efficacy is not an issue and the agency has not requested additional studies, the firm said.

Negotiations will likely address which secondary endpoints to include in the clinical trials sections of labeling and the possible inclusion of a pediatric section in Nuvigil labeling to identify potential risks, specifically severe dermatological reactions, the company said.

-Christopher Hollis

Nuvigil Labeling Will Likely Include Safety Information From Sparlon Clinical Trials

More from Archive

More from Pink Sheet