First and Only Dronabinol Solution Approved

Insys Therapeutics' Syndros (dronabinol) oral solution received FDA approval

/ Author:  / Reviewed by: Anyssa Garza, PharmD

(RxWiki News) The US Food and Drug Administration has approved the first and only dronabinol solution for oral use.

Syndros was approved to treat anorexia in patients with AIDS, as well as nausea and vomiting associated with cancer chemotherapy in those who did not have an adequate response to conventional treatment. 

Syndros' active ingredient, dronabinol, a pharmaceutical cannabinoid, is the pharmaceutical version of tetrahydrocannabinol (THC).

Dronabinol is currently on the market as a soft gel capsule. 

Since Syndros is available as an oral formulation, it offers those patients who have difficulty swallowing capsules a treatment alternative that may be easier to swallow. In addition, because Syndros is available as an oral solution, the dose can be adjusted in a more patient-specific manner. 

Common side effects may include feeling extremely happy, paranoia, abnormal thoughts and stomach pain. This medication may also cause dizziness and drowsiness. Do not drive, operate heavy machinery or perform other dangerous activities until you know how this medication affects you. 

The manufacturer of this medication warns about the risk for psychiatric and cognitive effects tied to this drug. 

Before taking Syndros, tell your doctor about all of your medical conditions, especially if you have or have had heart problems, have or have had problems with drug or alcohol abuse or dependence, have or have had mental health problems, take medications that contain disulfiram or metronidazole and have had a seizure or have a medical condition that may increase your risk of having a seizure.

Syndros is manufactured by Insys Therapeutics, Inc., and is expected to be launched in the second half of this year. 

This medication is currently awaiting scheduling by the Drug Enforcement Administration. 

Reviewed by: 
Review Date: 
July 6, 2016
Last Updated:
July 8, 2016