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FDA names potential Insys treatment an orphan drug

August 25, 2014

A potential treatment from Insys Therapeutics Inc. for an aggressive form of brain cancer will have some marketing exclusivity if regulators eventually approve it.

The Food and Drug Administration has granted an orphan drug designation to the Chandler, Arizona, drugmaker’s pharmaceutical cannabidiol, or CBD. Regulators give the designation to drugs that treat rare diseases affecting fewer than 200,000 patients in the United States. It offers some financial incentives to support development and seven years of U.S. marketing exclusivity if the treatment is approved.

Insys is studying CBD for the treatment of glioblastoma multiforme, the most common and aggressive malignant brain tumor in humans. The experimental treatment also has received the orphan drug designation for its potential to treatment some rare forms of epilepsy.

Cannabidiol is one of marijuana’s best-known components and is credited with various medical applications without providing a high.

Shares of Insys jumped more than 2 percent, or 74 cents, to $36.29 at the start of trading Monday, while broader indexes rose less than 1 percent.

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