FDA has recently approved a liquid form of synthetic marijuana.
The U.S. Food and Drug Administration (FDA) has recently approved the first liquid formulation of dronabinol, which is a synthetic version of THC (tetrahydrocannabinol) – the main psychoactive compound in marijuana.
The synthetic drug is under the brand name Syndros, and is classified under the Controlled Substances Act as Schedule III, which means it is safe for medical use and is free of addictive tendencies, unlike real cannabis, which is a Schedule I drug along with heroin.
Syndros, which was manufactured by Insys Therapeutics, is approved for use in treating anorexia associated with weight loss in patients with AIDS, as well as nausea and vomiting associated with cancer patients undergoing chemotherapy.
According to Dr. John N. Kapoor, CEO and president of Insys Therapeutics, 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,” Kapoor said in a press release.
According to Insys, there are currently 9,500 dronabinol prescriptions, and it hopes to convert a number of them to Syndros.
Dronabinol has been around since 1985 as a generic name for Marinol, a synthetic cannabinoid pill also manufactured by Insys. Marinol is also classified as Schedule III, but the drug is said to lack several therapeutic compounds available in natural cannabis and offer only limited relief to select patients. Moreover, as Syndros is in liquid form, it could be easier for patients to absorb than Marinol.
However, medical marijuana physician Perry Solomon said that a disadvantage of drugs like Syndros or Marinol is that they do not have the “entourage effect,” which is the synergistic reaction of all cannabis plant chemicals to one another. In the case of dronabinol where only the THC compound is present, the medicinal effect is weaker.
“Most of our patients like having the full spectrum of the effect of the medication,” Solomon told Motherboard.
According to Catherine Jacobson, director of clinical research at Canadian medical cannabis company Tilray, companies that manufacture synthetic versions of cannabis do all the clinical developments for the products.
“I think it is really important to understand the difference between a preparation that has gone through clinical development and one that hasn’t,” Jacobson told Motherboard.
“We would like to research on whole plant extracts. One of the holdups is the lack of safe, reliable, consistent products that are not pharmaceutical products.”