|Pronunciation||droe nab’ i nol|
|Trade names||Marinol, Syndros, Reduvo, Adversa, others|
|Main uses||Appetite stimulant in AIDS, chemotherapy induced nausea and vomiting|
|Side effects||Abdominal pain, dizziness, feeling high, paranoia, sleepiness, nausea, abnormal thinking|
Dronabinol, sold under the brand name Marinol among others, is a medication used to stimulate appetite in AIDS and for chemotherapy induced nausea and vomiting that is not managed with usual treatment. It is taken by mouth. Effects begin within an hour and may last for more than 24 hours.
Common side effect include abdominal pain, dizziness, feeling high, paranoia, sleepiness, nausea, and abnormal thinking. Other side effects may include seizures, fast heart rate, misuse, and low blood pressure. Use in pregnancy may harm the baby. It is a manufactured cannabinoid, an isomer of tetrahydrocannabinol, and the main psychoactive component of cannabis.
Dronabinol was approved for medical use in the United States in 1985. It is available as a generic medication. In the United States a dose of 2.5 mg twice per day costs about 52 USD as of 2021. In the United States it is a Schedule III controlled substance.
Appetite stimulant and anti-emetic
A mild overdose of dronabinol presents drowsiness, dry-mouth, euphoria, and tachycardia; whereas a severe overdose presents lethargy, slurred speech, decreased motor coordination, and postural hypotension.
While dronabinol was initially approved by the United States Food and Drug Administration on May 31, 1985, it was not until 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.
Society and culture
Dronabinol is marketed as Marinol and Syndros, a registered trademark of Solvay Pharmaceuticals. Dronabinol is also marketed, sold, and distributed by PAR Pharmaceutical Companies under the terms of a license and distribution agreement with SVC pharma LP, an affiliate of Rhodes Technologies for Marinol and Insys Pharmaceuticals for Syndros. Dronabinol is available as a prescription drug (under Marinol and Syndros ) in several countries including the United States, Germany, South Africa and Australia. In Canada, Tetra Bio-Pharma filed a New Drug Submission (NDS) with Health Canada for its Dronabinol Soft Gel capsules to be marketed as REDUVO™. Tetra has two other dronabinol drugs with new routes of administration which limit first-pass metabolism; an inhaled THC-based dronabinol drug and their mucoadhesive-delivery dronabinol drug Adversa®, which are both in the accelerated 505(b)(2) New Drug Application (NDA) pathway for the U.S. and Canadian markets.
In the United States, Marinol is a Schedule III drug, available by prescription, considered to be non-narcotic and to have a low risk of physical or mental dependence. Efforts to get cannabis rescheduled as analogous to Marinol have not succeeded thus far, though a 2002 petition has been accepted by the DEA. As a result of the rescheduling of Marinol from Schedule II to Schedule III, refills are now permitted for this substance. Marinol's U.S. Food and Drug Administration (FDA) approval for medical use has raised much controversy as to why cannabis is still illegal at the federal level.
Comparisons with medical cannabis
Female cannabis plants contain at least 113 cannabinoids, including cannabidiol (CBD), thought to be the major anticonvulsant that helps people with multiple sclerosis; and cannabichromene (CBC), an anti-inflammatory which may contribute to the pain-killing effect of cannabis.
It takes over one hour for Marinol to reach full systemic effect, compared to seconds or minutes for smoked or vaporized cannabis. Mark Kleiman, director of the Drug Policy Analysis Program at UCLA's School of Public Affairs said of Marinol, "It wasn't any fun and made the user feel bad, so it could be approved without any fear that it would penetrate the recreational market, and then used as a club with which to beat back the advocates of whole cannabis as a medicine."
Clinical trials comparing the use of cannabis extracts with Marinol in the treatment of cancer cachexia have demonstrated equal efficacy and well-being among subjects in the two treatment arms. United States federal law currently registers dronabinol as a Schedule III controlled substance, but all other cannabinoids remain Schedule I, except synthetics like nabilone and HU-308.
- 11-Hydroxy-THC, metabolite of THC
- Anandamide, 2-Arachidonoylglycerol, endogenous cannabinoid agonists
- Cannabidiol (CBD)
- Cannabinol (CBN), a metabolite of THC
- Tetrahydrocannabinolic acid, the biosynthetic precursor for THC
- HU-210, WIN 55,212-2, JWH-133, synthetic cannabinoid agonists (neocannabinoids)
- Medical cannabis (pharmaceutical cannabinoids)
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