Insys Therapeutics announced that the Drug Enforcement Agency (DEA) has issued an interim final rule that would lead to Syndros (dronabinol oral solution) being categorized as a Schedule II drug.

Syndros is an orally-administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC). The Food and Drug Administration (FDA) initially approved Syndros in July 2016 for the treatment of anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.  

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Syndros is anticipated to launch in the second half of 2017. It will be available as a 5mg/mL strength oral solution. 

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