Cancer pain drug Abstral filing accepted for review by FDA

Nov 2, 2009

ProStrakan Group has announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) filing for review of Abstral. Abstral is a sublingual formulation of the opioid fentanyl that rapidly disintegrates for treatment of breakthrough cancer pain. If Abstral completes the U.S. approval process successfully, the drug will be marketed in the United States during the second half of 2010.

Approximately 376 million breakthrough cancer pain attacks occur in the United States every year. Abstral will provide a convenient, effective way for cancer patients who are already taking opioid analgesics to treat their breakthrough cancer pain.

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