FDA Approves First-Ever Liquid Synthetic THC Formulation
Washington, DC: Regulators at the US Food and Drug Administration for the first time have approved the prescription of a liquid form of dronabinol ( synthetic THC ), to be marketed under the trade name Syndos.
The new drug formula, produced by Insys Therapeutics, is approved for use in patients with AIDS (as an appetite stimulant) and cancer (as an antiemetic).
The pharmaceutical provider is anticipated to publically launch the drug in the second half of this year.
The FDA initially approved the prescription use of dronabinol as an oral pill, marketed under the trade name Marinol, in 1985. Marinol is currently classified as a Schedule III controlled substance under the Controlled Substances Act. The prescription drug remains relatively unpopular with patients and physicians, largely because of its delayed onset, high degree of bioavailability, and potential dysphoric side effects, which tend to be far more pronounced than those associated with inhaled cannabis.
Insys Therapeutics previously received orphan drug approval status from the FDA in 2014 for a pharmaceutical formulation of cannabidiol (CBD).
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Paul Armentano is the Deputy Director of NORML, the National Organization for the Reform of Marijuana Laws, and a Senior Policy Advisor at Freedom Leaf. He also serves on the faculty of Oaksterdam University. Mr. Armentano’s writing and research on marijuana policy have appeared in well over 750 publications, scholarly and/or peer-reviewed journals, as well as in more than two dozen textbooks and anthologies. He is the co-author of the book Marijuana is Safer: So Why Are We Driving People to Drink? (2009, Chelsea Green), which has been licensed and translated internationally, and more recently, The Citizens’ Guide to State-by-State Marijuana Laws (Whitman Books, 2015). Mr. Armentano is the 2013 Freedom Law School Health Freedom Champion of the Year and the 2013 Alfred R. Lindesmith award recipient in the achievement in the field of scholarship.
