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news.Cephalon has been informed by the FDA that its Nuvigil drug for excessive sleepiness will be approved but will be required to carry a strong warning section about potential side effects.
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The FDA also said that there would have to be a warning section for the company’s older drug for sleepiness Provigil. The draft labeling includes a proposed bolded warning section that characterizes the potential occurrence of skin rash and hypersensitivity in patients taking the treatments.
Nuvigil is indicated for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).
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 agency has not requested any additional studies prior to final approval of Nuvigil.
Cephalon said it also plans to conduct clinical trials evaluating the use of Nuvigil as a treatment for conditions such as bipolar depression, cognition associated with schizophrenia, and excessive sleepiness and fatigue in conditions such as Parkinson’s disease and cancer.