FDA approves cannabis-based drug Syndros 
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Cannabis-based oral medication gains FDA approval.

Insys Therapeutics Inc. announced Tuesday, July 5, that the United States Food and Drug Administration (FDA) has approved the company’s drug Syndros, an orally administered liquid formulation of the synthetic cannabinoid dronabinol, according to a release.

The drug, which contains a synthetic version of tetrahydrocannabinol (THC), is approved for the treatment of weight loss in patients with AIDS, as well as nausea and vomiting associated with cancer chemotherapy in patients who have not responded to conventional treatments.

“We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with weight loss in AIDS,” said the company’s Chairman, CEO and president, Dr. John N. Kapoor.

Kapoor says Syndros’ easy-to-swallow liquid formulation allows for better dosing and doesn’t require refrigeration for 28 days.

“We believe that these product features coupled with patient support services will prove to be important differentiators for patients and prescribers and will be key drivers of a successful market launch and sustained growth,” Kapoor said.

Shares of Insys Therapeutics Inc. (INSY) climbed 19 percent in premarket trade following Tuesday’s announcement of FDA approval for the new cannabis-based medication, according to Market Watch.

Syndros now awaits scheduling by the U.S. Drug Enforcement Administration (DEA). The company expects to launch the drug in the second half of 2016.