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Jul 24, 2009

Nycomed’s Intranasal Fentanyl Drug Gains European Approval for Breakthrough Cancer Pain

  • The European Commission granted Nycomed marketing authorization for its cancer pain drug, Instanyl®. This intranasal fentanyl spray is indicated for managing breakthrough pain in adult patients who are already receiving maintenance opioid therapy for chronic pain. Nycomed plans to launch the product this year.

    “Instanyl has a fast onset, a short duration, is well tolerated, and is easy to use, allowing the patients effective control of the pain episodes with minor adverse effects,” notes Stein Kaasa, M.D., Ph.D., from Trondheim University Hospital in Norway, who was involved in conducting clinical trials with Instanyl. Dr. Kaasa is also chairman of the Research Network of the European Association for Palliative Care.

    Nycomed reports that this is the first intranasal fentanyl product sanctioned in Europe. In March Orexo’s obtained approval for its sublingual fentanyl treatment for breakthrough cancer pain, Abstral, from regulatory authorities in France and Spain. Abstral has also received a positive recommendation for approval by the EMEA. It is currently distributed in Sweden, the U.K., and Germany. 

    In the U.S., the FDA recently approved BioDelivery Sciences’ breakthrough cancer pain product, Onsolis. This is the first product to utilize the company’s bioerodible mucoadhesive drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa. Onsolis is expected to be available early in the fourth quarter.

     



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