Use of sleep disorder drug could be limited in Europe

European health regulators recommended on Thursday restricting the use of Cephalon’s sleep disorder drug Provigil for treating narcolepsy only, over concerns that risks may outweigh the benefits of the medicine in other uses.

The European Medicines Agency said doctors and patients should no longer use medicines that contain modafinil - the active ingredient in Provigil - for sleep apnea, chronic shift work sleep disorder or other previously approved uses.

A review of the drug was initiated by European regulators over a number of safety concerns related to psychiatric disorders, skin and subcutaneous tissue reactions as well as significant off-label use and potential for abuse, the agency said.

On the basis of the available data the agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the drug only outweighs the risks in the treatment of narcolepsy, a chronic sleep disorder characterized by excessive daytime sleepiness.

Narcolepsy was the original use for which Provigil was approved.

For all other uses European officials said safety risks outweighed evidence of clinical efficacy.

The CHMP also identified particular cardiovascular risks with modafinil and recommended that it not be prescribed to patients with uncontrolled High Blood Pressure or irregular heart rhythms.

“Modafinil has been used safely and effectively for its licensed indications in Europe for many years and we believe the risk/benefit profile in all approved indications is positive,” Cephalon spokeswoman Candace Steele Flippin said.

Modafinil is currently licensed in 21 countries in Europe.

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By Bill Berkrot

NEW YORK (Reuters)