Dronabinol

Not to be confused with Droperidol.
Dronabinol
Names
Pronunciationdroe nab’ i nol[1]
Trade namesMarinol, Syndros, Reduvo, Adversa, others
Clinical data
Drug classCannabinoid[1]
Main usesAppetite stimulant in AIDS, chemotherapy induced nausea and vomiting[2]
Side effectsAbdominal pain, dizziness, feeling high, paranoia, sleepiness, nausea, abnormal thinking[2]
External links
AHFS/Drugs.comMonograph

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.[2][3] It is taken by mouth.[1] Effects begin within an hour and may last for more than 24 hours.[4]

Common side effect include abdominal pain, dizziness, feeling high, paranoia, sleepiness, nausea, and abnormal thinking.[2] Other side effects may include seizures, fast heart rate, misuse, and low blood pressure.[2][1] Use in pregnancy may harm the baby.[2] It is a manufactured cannabinoid, an isomer of tetrahydrocannabinol, and the main psychoactive component of cannabis.[4][1]

Dronabinol was approved for medical use in the United States in 1985.[4] It is available as a generic medication.[5] In the United States a dose of 2.5 mg twice per day costs about 52 USD as of 2021.[5] In the United States it is a Schedule III controlled substance.[1]

Medical uses

Appetite stimulant and anti-emetic

Dronabinol is used to stimulate appetite and therefore weight gain in people with HIV/AIDS and cancer. It is also used to treat chemotherapy-induced nausea and vomiting.[6]

Pain

Dronabinol has been used for chronic pain, the data in acute pain is less conclusive.[7] Such use; however, is not recommended in the United Kingdom.[8]

Addiction

Dronabinol has been proposed as a treating cannabis addiction as it reduce cannabis withdrawal symptoms and the subjective effects of marijuana.[9]

Dosage

It is initially started at a dose of 2.5 mg twice per day.[2] This may be increased up to 20 mg per day.[1]

Overdose

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.[10][11]

History

While dronabinol was initially approved by the United States Food and Drug Administration on May 31, 1985,[12] 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.[13] 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.[14]

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.[12] 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".[15]

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.[16]

Society and culture

Brand names

Dronabinol is marketed as Marinol and Syndros,[17] 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 [18]) in several countries including the United States, Germany, South Africa and Australia.[19] 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™.[20] 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.[21]

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[22] as to why cannabis is still illegal at the federal level.[23]

Comparisons with medical cannabis

Further information: Medical cannabis

Female cannabis plants contain at least 113 cannabinoids,[24] including cannabidiol (CBD), thought to be the major anticonvulsant that helps people with multiple sclerosis;[25] and cannabichromene (CBC), an anti-inflammatory which may contribute to the pain-killing effect of cannabis.[26]

It takes over one hour for Marinol to reach full systemic effect,[27] compared to seconds or minutes for smoked or vaporized cannabis.[28] 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."[29]

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.[30] 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.[31][32]

Research

Sleep apnea

Dronabinol has been studied in sleep apnea.[33][34] Phase 2B clinical trials were completed in 2017.[35][36][37]

See also

References

  1. 1 2 3 4 5 6 7 "Dronabinol". LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. National Institute of Diabetes and Digestive and Kidney Diseases. 2012. Archived from the original on 6 May 2021. Retrieved 27 December 2021.
  2. 1 2 3 4 5 6 7 "DailyMed - DRONABINOL capsule". dailymed.nlm.nih.gov. Archived from the original on 25 March 2021. Retrieved 27 December 2021.
  3. ↑ Badowski ME (September 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. 80 (3): 441–449. doi:10.1007/s00280-017-3387-5. PMC 5573753. PMID 28780725.
  4. 1 2 3 "Dronabinol Monograph for Professionals". Drugs.com. Archived from the original on 4 March 2021. Retrieved 27 December 2021.
  5. 1 2 "Dronabinol Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 27 December 2021.
  6. ↑ Melissa E Badowski and Paa Kwesi Yanful (2018). "Dronabinol oral solution in the management of anorexia and weight loss in AIDS and cancer". Ther Clin Risk Manag. 14: 643–651. doi:10.2147/TCRM.S126849. PMC 5896684. PMID 29670357.{{cite journal}}: CS1 maint: uses authors parameter (link)
  7. ↑ de Vries M, van Rijckevorsel DC, Wilder-Smith OH, van Goor H. (2014). "Dronabinol and chronic pain: importance of mechanistic considerations". Expert Opinion on Pharmacotherapy. 15 (11): 1525–34. doi:10.1517/14656566.2014.918102. PMID 24819592. S2CID 31008562.{{cite journal}}: CS1 maint: uses authors parameter (link)
  8. ↑ BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 461. ISBN 978-0857114105.
  9. ↑ Levin FR, Kleber HD. (2008). "Use of dronabinol for cannabis dependence: two case reports and review". Am J Addict. 17 (2): 161–4. doi:10.1080/10550490701861177. PMC 2733248. PMID 18393061.{{cite journal}}: CS1 maint: uses authors parameter (link)
  10. ↑ "Marinol (Dronabinol)" (PDF). US Food and Drug Administration. September 2004. Archived (PDF) from the original on 10 February 2017. Retrieved 14 January 2018.
  11. ↑ "Dronabinol capsule (American Health Packaging)". US National Library of Medicine. July 2012. Archived from the original on 30 August 2014. Retrieved 12 January 2014.
  12. 1 2 "1999 - Rescheduling of the Food and Drug Administration Approved Product Containing Synthetic Dronabinol [(-)-D9-(trans)-Tetrahydrocannabinol] in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule II to Schedule III". DEA Diversion Control Division. 1999-07-02. Archived from the original on 2021-05-01. Retrieved 2021-05-19.
  13. ↑ 51 Fed. Reg. 17476 (1986), Tuesday, May 13, 1986, pages 17476-17478
  14. ↑ 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.
  15. ↑ "Petition to Reschedule Cannabis (Marijuana)" (PDF). Coalition for Rescheduling Cannabis. 9 October 2002. Archived (PDF) from the original on 8 April 2018. Retrieved 26 July 2021.
  16. ↑ "WHO Expert Committee on Drug Dependence". World Health Organization. Archived from the original on 13 December 2013. Retrieved 12 January 2014.
  17. ↑ EMCDDA, ELDD Comparative Study, May 2002.
  18. ↑ "Marinol – the Legal Medical Use for the Marijuana Plant". Drug Enforcement Administration. Archived from the original on 21 October 2002. Retrieved 20 April 2011.
  19. ↑ Alchimia Blog, Marijuana and Medicine: Cesamet, Marinol, Sativex Archived 2020-08-02 at the Wayback Machine
  20. ↑ Dec 30, 2020, AP News, Tetra Bio-Pharma Files New Drug Submission for REDUVO™ in Canada Archived 2021-01-18 at the Wayback Machine
  21. ↑ TBP Dec 16, 2020, Tetra Bio-Pharma Hits Another Milestone Before Year End: Inhaled Dronabinol & MucoAdhesive Dronabinol 'Adversa™' Archived 2020-11-26 at the Wayback Machine
  22. ↑ Downs, David (21 October 2014). "War on marijuana unconstitutional, doctors testify in federal court Monday". sfgate.com. Archived from the original on 22 October 2014. Retrieved 21 October 2014.
  23. ↑ Eustice, Carol (12 August 1997). "Medicinal Marijuana: A Continuing Controversy". About.com. Archived from the original on 15 June 2011. Retrieved 20 April 2011.
  24. ↑ Aizpurua-Olaizola O, Soydaner U, Öztürk E, Schibano D, Simsir Y, Navarro P, Etxebarria N, Usobiaga A (February 2016). "Evolution of the Cannabinoid and Terpene Content during the Growth of Cannabis sativa Plants from Different Chemotypes". Journal of Natural Products. 79 (2): 324–31. doi:10.1021/acs.jnatprod.5b00949. PMID 26836472.
  25. ↑ Pickens JT (April 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.
  26. ↑ Burns TL, Ineck JR (February 2006). "Cannabinoid analgesia as a potential new therapeutic option in the treatment of chronic pain". The Annals of Pharmacotherapy. 40 (2): 251–60. doi:10.1345/aph.1G217. PMID 16449552. S2CID 6858360.
  27. ↑ MARINOL (dronabinol) capsule drug label/data at DailyMed from U.S. National Library of Medicine, National Institutes of Health.
  28. ↑ McKim, William A (2002). Drugs and Behavior: An Introduction to Behavioral Pharmacology (5th ed.). Prentice Hall. p. 400. ISBN 978-0-13-048118-4.
  29. ↑ Greenberg, Gary (1 November 2005). "Respectable Reefer". Mother Jones. Archived from the original on 18 January 2018. Retrieved 8 April 2010.
  30. ↑ "Cannabis and Cannabinoids (PDQ)". Cancer Topics. National Cancer Institute, U.S. Department of Health and Human Services. 2011-03-16. Archived from the original on 2015-04-06. Retrieved 2021-07-26.
  31. ↑ "Government eases restrictions on pot derivative". Online Athens. Archived from the original on 2014-12-16. Retrieved 12 January 2014.
  32. ↑ "21 CFR — SCHEDULES OF CONTROLLED SUBSTANCES §1308.11 Schedule I." Archived from the original on 2009-08-27. Retrieved 2021-07-26.
  33. ↑ "Proof of Concept Trial of Dronabinol in Obstructive Sleep Apnea". ResearchGate. Archived from the original on 2021-08-28. Retrieved 2018-11-04.
  34. ↑ Carley DW, Prasad B, Reid KJ, Malkani R, Attarian H, Abbott SM, Vern B, Xie H, Yuan C, Zee PC (January 2018). "Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea". Sleep. 41 (1). doi:10.1093/sleep/zsx184. PMC 5806568. PMID 29121334.
  35. ↑ "Drug Dronabinol Reduces Symptoms of Obstructive Sleep Apnea, Finds Phase 2B Study - Sleep Review". Sleep Review. Archived from the original on 2019-06-21. Retrieved 2018-11-04.
  36. ↑ "Synthetic Cannabis-Like Drug Reduces Sleep Apnea". Neuroscience News. 2017-11-29. Archived from the original on 2019-06-21. Retrieved 2018-11-04.
  37. ↑ Carley, DW; Prasad, B; Reid, KJ; Malkani, R; Attarian, H; Abbott, S; Vern, B; Xie, H; Yuan, C (2017-04-28). "0558 Dronabinol Reduces Ahi and Daytime Sleepiness in Patients with Moderate to Severe Obstructive Sleep Apnea Syndrome". Sleep. 40 (suppl_1): A207–A208. doi:10.1093/sleepj/zsx050.557. ISSN 0161-8105.
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