FDA Clears Oral Cannabis Drug for AIDS, Cancer Patients

Megan Brooks

July 06, 2016

The US Food and Drug Administration (FDA) has approved dronabinol oral solution (Syndros, Insys Therapeutics, Inc) for the treatment of anorexia associated with weight loss in patients with AIDS and for nausea and vomiting associated with cancer chemotherapy in patients who fail to respond adequately to conventional antiemetic treatments, according to a company news release.

Syndros is a proprietary liquid formulation of the synthetic cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC).

"Syndros is the first and only FDA approved dronabinol solution for oral use. It is a liquid that is easy-to-swallow and allows for the dosage to be titrated to clinical effect. Once Syndros has been opened, it does not need to be refrigerated for 28 days," Insys Chairman, CEO, and PresidentJohn N. Kapoor, PhD, said in the news release.

The company anticipates launching Syndros in the second half of 2016. Syndros is currently awaiting scheduling by the US Drug Enforcement Administration.

Use of Syndros may cause psychiatric and cognitive effects and may impair mental and/or physical abilities. Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia, the company notes. They advise withholding products containing disulfiram or metronidazole for at least 14 days before administration and that these products not be administered for 7 days after treatment with Syndros.

They say the potential risks vs benefits should be assessed before prescribing Syndros to patients with a history of seizures, including those requiring antiepileptic medication or those with other factors that lower the seizure threshold. Patients with a history of substance abuse or dependence should be assessed for risk for abuse or misuse prior to prescribing Syndros. Such patients should be monitored for the development of associated behaviors or conditions, according to the company. If symptoms of paradoxical nausea, vomiting, or abdominal pain worsen while receiving treatment, dose reduction or discontinuation should be considered.

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