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The price hikes were in preparation for the expected launch of Nuvigil in 2009. By sharply raising prices, Cephalon hoped to convert patients to Nuvigil before cheap generic versions of Provigil came on the market. Doctors and patients should be advised to use the drug only for the treatment of narcolepsy and all other indications should be withdrawn from market authorization, the press release said. The drug maker "also structured its sales quota and bonuses in such a way that sales representatives could only reach their sales goals if they promoted and sold the drugs for off-label uses," the press release notes.
The recommendations were forwarded to the European Commission for the adoption of a binding decision, the press release said. The Medicines and Healthcare product Regulatory Agency issued a "stop press" notice in the August 2010 edition of "Drug Safety Update," reminding healthcare professionals of the EMA’s recommendations. Modafinil is potentially safe in patients with epilepsy, but further prospective studies are needed to fully determine its safety and efficacy. Modafinil has been shown to ameliorate these symptoms, but its use in patients with seizures has been limited because of safety concerns.
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