Cephalon plans to respond within 30 days to an "approvable" letter for its Provigil (modafinil) follow-on Nuvigil , (armodafinil), the firm announced March 30.

"The draft labeling includes a proposed bolded warning section that characterizes the potential occurrence of skin rash and hypersensitivity in patients taking modafinil and armodafinil," Cephalon said. Further warning language was not disclosed.

"The agency also has indicated that it will request similar language in the label for Provigil," the firm added. Cephalon would likely have to submit such a labeling change as an sNDA.

The letter is the second such decision for Nuvigil; the initial approvable letter was issued in April 2006 (¹ Also see "Nuvigil Labeling Will Likely Include Safety Information From Sparlon Clinical Trials" - Pink Sheet, 2 May, 2006.).

Cephalon had sought to market the chemically related compound Provigil for attention deficit hyperactivity disorder under the trade name Sparlon , but was derailed after skin adverse events were seen in children, including one case of Stevens Johnson syndrome. The firm dropped Sparlon after a "not approvable" letter (² Also see "Spar-Gone: Cephalon Drops Sparlon Following "Non-Approvable" Letter" - Pink Sheet, 9 August, 2006.). Nuvigil is a single-isomer formulation of Provigil.

Cephalon added that "among other things, the agency has requested that the company provide a standard safety update from clinical trials conducted since the last update in June 2006, and introductory promotional materials to be used for the product. The company's response will be submitted within 30 days and will be considered a Class 1 response," the Frazer, Pa., firm said, noting that FDA is not requesting any additional clinical studies.

"While we fully appreciate that this regulatory review has been difficult and lengthy for stockholders and others interested in the outcome, we are convinced that in this unusual situation where multiple products may be affected, the final result will prove to be worth the investment of time and effort," CEO Frank Baldino said in a statement.

Cephalon is seeking claims for use of Nuvigil in excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder.

- Lee Szilagyi (l.szilagyi@elsevier.com)

Nuvigil Draft Label Warning Includes Both Modafinil And Its Follow-On

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