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CHMP recommends approval of Abstral

The CHMP has recommended Prostrakanís cancer pain drug, Abstral, for approval by the EMEA

The Committee for Medicinal Products for Human Use (CHMP) has recommended Prostrakan's cancer pain drug, Abstral, for approval by the European Medicines Agency (EMEA).

Abstral is a new formulation of fentanyl and is administered as a fast dissolving, under-the-tongue tablet. It is intended for the treatment of breakthrough pain in cancer patients already receiving opioid analgesics.

Swedish pharmaceutical company Orexo AB developed Abstral. They have out-licensed the European marketing rights to ProStrakan, who plan to launch the drug in Sweden in Q3 2008 and across the rest of Europe by the end of the year. As a post-approval commitment, ProStraken has agreed to supply the EMEA with final data from its ongoing clinical programme in North America.

Dr Wilson Totten, CEO of ProStrakan, said: "This is a very significant announcement for ProStrakan. Abstral will play a major role in the further development of our European business while, at the same time, providing clinicians with a patient-friendly formulation of fentanyl to prescribe to cancer patients suffering from breakthrough pain."

About 65 per cent of cancer patients that suffer related pain and are taking pain relief suffer additional flares of pain known as breakthrough pain. This pain may be caused by the cancer or may be related to the cancer treatment.

27th June 2008


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