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ProStraken gets FDA clearance for cancer pain management drug

The US Food and Drug Administration (FDA) has approved ProStraken's Abstral (fentanyl) transmucosal tablets for management of breakthrough pain in adults with cancer.

Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth or the nasal passages or throat where they dissolve and are absorbed.

Abstral is indicated for use by cancer patients ages 18 years and older, who already use opioid medication round the clock, who need and can safely use high doses of an opioid medication.

The medication should be prescribed by only health care professionals skilled in the use of Schedule II opioids to treat pain.

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) programme which is designed to minimise the risk of misuse, abuse, addiction and overdose.