A new pharmaceutical drug produced by the company Insys has received approval for placement in Schedule II classification by the DEA after a two year long process to get the approval. The Drug Enforcement Administration (DEA) made the recommendation and made the following findings from the Food and Drug Administration (FDA):
- FDA-approved products containing dronabinol in an oral solution have a high potential for abuse. The physicochemical properties of Syndros allow extraction of dronabinol for abuse through oral or inhalation (smoking or vaping) routes. Dronabinol is not easily extractable from Marinol. Oral abuse of dronabinol-containing products is associated with hallucinations, mood alterations, and paranoia.
- FDA-approved products containing dronabinol in an oral solution have a currently accepted medical use in treatment in the United States. The FDA approved an oral solution containing dronabinol (Syndros) for the treatment of anorexia associated with weight loss in patients with AIDS, and for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
- FDA-approved products containing dronabinol in an oral solution may lead to severe physical dependence. Following discontinuation of dronabinol at a dose 210 mg/day (25 times higher than the recommended daily dose for anorexia associated with weight loss in AIDS patients) for 12 to 16 consecutive days, withdrawal symptoms including irritability, insomnia, and restlessness were observed at 12 hours after discontinuation.
Based on these findings the DEA decided that Schedule II was an appropriate place for Dronabidiol, the active ingredient in Syndros® Oral Solution. The rule only applies to oral solutions of the drug. The named brand solution contains a 5mg per ml dose of dronabidiol. The drug was initially approved in July of last year but was a schedule I drug. Unfortunately, the restrictions on a schedule II drug are almost identical to schedule I.