Cephalon said that the European Committee for Medicinal Products for Human Use has issued a positive opinion regarding Effentora, the company's fentanyl buccal tablet cancer pain medication.
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In March 2007, Cephalon has submitted the Effentora European new drug application for the treatment of breakthrough pain in adult cancer patients who are already receiving maintenance opioid therapy for chronic cancer pain. The Committee for Medicinal Products for Human Use (CHMP) recommendation for Effentora will now be forwarded to the European Commission for final marketing approval, which typically occurs within 60 to 90 days.
Alain Aragues, president of Cephalon Europe, said: “We believe this product, once approved, will be an exciting addition to our European product portfolio and will provide a tremendous benefit to patients suffering from breakthrough cancer pain.”
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