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.
A separate synthetic cannabinoid drug, nabilone (trade name Cesamet), received FDA approval for use by prescription in 2006.
Insys Therapeutics previously received orphan drug approval status from the FDA in 2014 for a pharmaceutical formulation of cannabidiol (CBD).