Dronabinol

Dronabinol – trade names Marinol and Syndros – is a synthetic form of tetrahydrocannabinol (THC) approved by the FDA as an appetite stimulant for people with AIDS and antiemetic for people receiving chemotherapy.[1] THC is the principal psychoactive constituent of cannabis. With chemical name, (−)-trans-Δ⁹-tetrahydrocannabinol, the term THC also refers to cannabinoid isomers. The pharmaceutical formulation dronabinol is an oily resin provided in capsules available by prescription in the US, Canada, Germany, Australia and New Zealand.

Medical uses

Dronabinol is the INN for a pure isomer of THC, (−)-trans-Δ⁹-tetrahydrocannabinol,[2] which is the main THC isomer found in cannabis. It is used to treat anorexia in people with HIV/AIDS as well as for refractory nausea and vomiting in people undergoing chemotherapy and anorexia.[1] It is safe and effective for these uses.[1][3][4]

Adverse effects

A mild overdose of dronabinol induces drowsiness, euphoria, dry mouth, and tachycardia, whereas a severe overdose presents with lethargy, decreased motor coordination, slurred speech, and postural hypotension.[1][5]

History

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.[6] 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.[7]

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".[8]

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.[9]

Society and culture

Brand names

Dronabinol is marketed as Marinol and Syndros,[10] 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 [11]) in several countries including the United States, Germany, South Africa and Australia.[12] 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[13] as to why natural THC is considered a schedule I drug.[14]

Comparisons with medical cannabis

Female cannabis plants contain at least 113 cannabinoids,[15] including cannabidiol (CBD), thought to be the major anticonvulsant that helps people with multiple sclerosis;[16] and cannabichromene (CBC), an anti-inflammatory which may contribute to the pain-killing effect of cannabis.[17]

It takes over one hour for Marinol to reach full systemic effect,[18] compared to seconds or minutes for smoked or vaporized cannabis.[19] Some people accustomed to inhaling just enough cannabis smoke to manage symptoms have complained of too-intense intoxication from Marinol's predetermined dosages. Many people using Marinol have said that Marinol produces a more acute psychedelic effect than cannabis, and it has been speculated that this disparity can be explained by the moderating effect of the many non-THC cannabinoids present in cannabis. For that reason, alternative THC-containing medications based on botanical extracts of the cannabis plant such as nabiximols are being developed. 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."[20] 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.[21] United States federal law currently registers dronabinol as a Schedule III controlled substance, but all other cannabinoids remain Schedule I, except synthetics like nabilone.[22]

See also

References

  1. 1 2 3 4 "Marinol (Dronabinol)" (PDF). US Food and Drug Administration. September 2004. Retrieved 14 January 2018.
  2. ↑ "List of psychotropic substances under international control". International Narcotics Control Board. International Narcotics Control Board. Archived from the original (PDF) on |archive-url= requires |archive-date= (help). Retrieved 25 April 2018. This international non-proprietary name refers to only one of the stereochemical variants of delta-9-tetrahydrocannabinol, namely (−)-trans-delta-9-tetrahydrocannabinol
  3. ↑ "Cannabis and Cannabinoids". National Cancer Institute. Retrieved 12 January 2014.
  4. ↑ Badowski, ME (5 August 2017). "A review of oral cannabinoids and medical marijuana for the treatment of chemotherapy-induced nausea and vomiting: a focus on pharmacokinetic variability and pharmacodynamics". Cancer chemotherapy and pharmacology. doi:10.1007/s00280-017-3387-5. PMC 5573753. PMID 28780725.
  5. ↑ "Dronabinol capsule (American Health Packaging)". US National Library of Medicine. July 2012. Retrieved 12 January 2014.
  6. ↑ 51 Fed. Reg. 17476 (1986), Tuesday, May 13, 1986, pages 17476-17478
  7. ↑ Calhoun SR, Galloway GP, Smith DE (1998). "Abuse potential of dronabinol (Marinol)". Journal of Psychoactive Drugs. 30 (2): 187–96. doi:10.1080/02791072.1998.10399689. PMID 9692381.
  8. ↑ "Petition to Reschedule Cannabis (Marijuana)" (PDF). Coalition for Rescheduling Cannabis. 9 October 2002.
  9. ↑ "WHO Expert Committee on Drug Dependence". World Health Organization. Retrieved 12 January 2014.
  10. ↑ EMCDDA, ELDD Comparative Study, May 2002.
  11. ↑ "Marinol – the Legal Medical Use for the Marijuana Plant". Drug Enforcement Administration. Archived from the original on 21 October 2002. Retrieved 20 April 2011.
  12. ↑ Alchimia Blog, Marijuana and Medicine: Cesamet, Marinol, Sativex
  13. ↑ Downs, David (21 October 2014). "War on marijuana unconstitutional, doctors testify in federal court Monday". sfgate.com. Retrieved 21 October 2014.
  14. ↑ Eustice, Carol (12 August 1997). "Medicinal Marijuana: A Continuing Controversy". About.com. Retrieved 20 April 2011.
  15. ↑ Aizpurua-Olaizola, Oier; Soydaner, Umut; Öztürk, Ekin; Schibano, Daniele; Simsir, Yilmaz; Navarro, Patricia; Etxebarria, Nestor; Usobiaga, Aresatz (2016-02-26). "Evolution of the Cannabinoid and Terpene Content during the Growth of Cannabis sativa Plants from Different Chemotypes". Journal of Natural Products. 79 (2): 324–331. doi:10.1021/acs.jnatprod.5b00949. ISSN 0163-3864. PMID 26836472.
  16. ↑ Pickens JT (1981). "Sedative activity of cannabis in relation to its delta'-trans-tetrahydrocannabinol and cannabidiol content". British Journal of Pharmacology. 72 (4): 649–56. doi:10.1111/j.1476-5381.1981.tb09145.x. PMC 2071638. PMID 6269680.
  17. ↑ Burns TL, Ineck JR (2006). "Cannabinoid Analgesia as a Potential New Therapeutic Option in the Treatment of Chronic Pain". Annals of Pharmacotherapy. 40 (2): 251–260. doi:10.1345/aph.1G217. PMID 16449552.
  18. ↑ MARINOL (dronabinol) capsule drug label/data at Daily Med from U.S. National Library of Medicine, National Institutes of Health.
  19. ↑ McKim, William A (2002). Drugs and Behavior: An Introduction to Behavioral Pharmacology (5th ed.). Prentice Hall. p. 400. ISBN 0-13-048118-1.
  20. ↑ Greenberg, Gary (1 November 2005). "Respectable Reefer". Mother Jones. Retrieved 8 April 2010.
  21. ↑ "Cannabis and Cannabinoids (PDQ®)". Cancer Topics. National Cancer Institute, U.S. Department of Health and Human Services.
  22. ↑ "Government eases restrictions on pot derivative". Online Athens. Retrieved 12 January 2014.
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