Dronabinol

The International Nonproprietary Name Dronabinol, sold as trade names Marinol and Syndros, is an appetite stimulant, antiemetic, and sleep apnea reliever. It is approved by the FDA as safe and effective for HIV/AIDS-induced anorexia and chemotherapy-induced nausea and vomiting only. The International Nonproprietary Name Dronabinol, sold as trade names Marinol and Syndros, is an appetite stimulant, antiemetic, and sleep apnea reliever. It is approved by the FDA as safe and effective for HIV/AIDS-induced anorexia and chemotherapy-induced nausea and vomiting only. The pharmaceutical formulation, an oily resin in capsules, is available by prescription in the US, Canada, Germany, Australia and New Zealand. Possible exceptions for off label use may be in US states passing laws reserving the right to differ from particular FDA regulations. Dronabinol is the principal psychoactive constituent enantiomer form, (−)-trans-Δ⁹-tetrahydrocannabinol, found in cannabis. Dronabinol does not include the many other tetrahydrocannabinol (THC) isomers of cannabinoid. Dronabinol is used to stimulate appetite and therefore weight gain in patients with HIV/AIDS and cancer. It is also used to treat chemotherapy-induced nausea and vomiting.Dronabinol demonstrates significant improvement in sleep apnea scores. Phase 2B clinical trials for FDA approval were completed in 2017. A mild overdose of dronabinol presents drowsiness, cotton-mouth, euphoria, and tachycardia; whereas a severe overdose presents lethargy, slurred speech, decreased motor coordination, and postural hypotension. On May 13, 1986, the Drug Enforcement Administration (DEA) issued a Final Rule and Statement of Policy authorizing the 'rescheduling of synthetic dronabinol in sesame oil and encapsulated in soft gelatin capsules from Schedule I to Schedule II' (DEA 51 FR 17476-78). This permitted medical use of Marinol, albeit with the severe restrictions associated with Schedule II status. For instance, refills of Marinol prescriptions were not permitted. At its 10th meeting, on April 29, 1991, the Commission on Narcotic Drugs, in accordance with article 2, paragraphs 5 and 6, of the Convention on Psychotropic Substances, decided that Δ⁹-tetrahydrocannabinol (also referred to as Δ⁹-THC) and its stereochemical variants should be transferred from Schedule I to Schedule II of that Convention. This released Marinol from the restrictions imposed by Article 7 of the Convention (See also United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances). An article published in the April–June 1998 issue of the Journal of Psychoactive Drugs found that 'Healthcare professionals have detected no indication of scrip-chasing or doctor-shopping among the patients for whom they have prescribed dronabinol'. The authors state that Marinol has a low potential for abuse. In 1999, Marinol was rescheduled from Schedule II to III of the Controlled Substances Act, reflecting a finding that THC had a potential for abuse less than that of cocaine and heroin. This rescheduling constituted part of the argument for a 2002 petition for removal of cannabis from Schedule I of the Controlled Substances Act, in which petitioner Jon Gettman noted, 'Cannabis is a natural source of dronabinol (THC), the ingredient of Marinol, a Schedule III drug. There are no grounds to schedule cannabis in a more restrictive schedule than Marinol'. At its 33rd meeting, in 2003, the World Health Organization Expert Committee on Drug Dependence recommended transferring THC to Schedule IV of the Convention, citing its medical uses and low abuse potential.