Dronabinol

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Not to be confused with Droperidol.
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Dronabinol (

INN), also known under the trade names Marinol and Syndros, is a generic name for the molecule of delta-9-tetrahydrocannabinol in the pharmaceutical context. It has indications as an appetite stimulant, antiemetic, and sleep apnea reliever[1] and is approved by the FDA as safe and effective for HIV/AIDS-induced anorexia and chemotherapy-induced nausea and vomiting only.[2][3][4]

Dronabinol is the principal

isomers or any cannabidiol
.

Medical uses

Appetite stimulant and anti-emetic

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.[6][7]

Analgesic

Dronabinol demonstrated analgesic efficacy in a majority of studies in chronic pain, the data in acute pain is less conclusive.[8]

Cannabis addiction

Dronabinol may be useful in treating cannabis addiction as it has been shown to reduce cannabis withdrawal symptoms and the subjective effects of marijuana.[9]

Sleep apnea

Dronabinol demonstrates significant improvement in sleep apnea scores.[1][10][11][12] Phase 2B clinical trials were completed in 2017 for FDA approval for this indication.[13][14][15]

Overdose

A mild overdose of dronabinol presents drowsiness, dry-mouth,

postural hypotension.[2][16]

History

While dronabinol was initially approved by the United States Food and Drug Administration on May 31, 1985,[17] 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.[18] For instance, refills of Marinol prescriptions were not permitted.

On April 29, 1991, the

Commission on Narcotic Drugs, in accordance with article 2, paragraphs 5 and 6, of the Convention on Psychotropic Substances of 1971, 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 Δ9-THC from many of the restrictions imposed by the convention, facilitating its marketing as medication.[19]

An article published in the April–June 1998 issue of the

better source needed
]

In 1999, in the United States, Marinol was rescheduled from Schedule II to III of the

better source needed
]

In 2003, the

Schedule IV of the convention, citing its medical uses and low abuse potential.[22] In 2019, the Committee recommended transferring Δ9-THC to Schedule I of the Single Convention on Narcotic Drugs of 1961, but its recommendations were rejected by the United Nations Commission on Narcotic Drugs.[23]

Society and culture

Brand names

Dronabinol is marketed as Marinol and Syndros,

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.[citation needed] Dronabinol is available as a prescription drug (under Marinol and Syndros [25]) in several countries including the United States, Germany, South Africa and Australia.[26] 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™.[27] 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.[28]


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[29] as to why cannabis is still illegal at the federal level.[30]

Comparisons with medical cannabis

Further information: Medical cannabis

Female cannabis plants not only contain dronabinol but at least 113 other cannabinoids,[31] including cannabidiol (CBD), thought to be the major anticonvulsant that helps people with multiple sclerosis;[32] and cannabichromene (CBC), an anti-inflammatory which may contribute to the pain-killing effect of cannabis.[33]

It takes over one hour for Marinol to reach full systemic effect,

vaporized cannabis.[35] 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."[36]

Clinical trials comparing the use of cannabis extracts with Marinol in the treatment of cancer

HU-308.[38][39]

See also

References

  1. ^
    S2CID 233242139
    . Initial rodent studies showed that injections of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, in the nodose ganglia suppressed serotonin induced reflex apneas and increased upper airway dilating muscle activity during sleep. Limited studies in humans with moderate-to-severe OSA have demonstrated significant reduction in AHI with dronabinol use.
  2. ^ a b "Marinol (Dronabinol)" (PDF). US Food and Drug Administration. September 2004. Retrieved 14 January 2018.
  3. ^ "Cannabis and Cannabinoids". National Cancer Institute. 2011-10-24. Retrieved 12 January 2014.
  4. PMID 28780725
    .
  5. ^ "List of psychotropic substances under international control". International Narcotics Control Board. 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
  6. PMID 29670357
    .
  7. PMID 27274310
    .
  8. S2CID 31008562
    .
  9. PMID 18393061
    .
  10. PMID 23346060
    .
  11. ^ "Can Dronabinol Help Treat Sleep Apnea? | HealthCentral". www.healthcentral.com. 25 April 2018. Retrieved 2018-11-04.
  12. PMID 29121334
    .
  13. ^ "Drug Dronabinol Reduces Symptoms of Obstructive Sleep Apnea, Finds Phase 2B Study - Sleep Review". Sleep Review. Retrieved 2018-11-04.
  14. ^ "Synthetic Cannabis-Like Drug Reduces Sleep Apnea". Neuroscience News. 2017-11-29. Retrieved 2018-11-04.
  15. ISSN 0161-8105
    .
  16. ^ "Dronabinol capsule (American Health Packaging)". US National Library of Medicine. July 2012. Retrieved 12 January 2014.
  17. ^ a b "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.
  18. ^ 51 Fed. Reg. 17476 (1986), Tuesday, May 13, 1986, pages 17476-17478
  19. ISBN 979-10-97087-06-7
    .
  20. PMID 9692381
    .
  21. Coalition for Rescheduling Cannabis
    . 9 October 2002.
  22. ^ "WHO Expert Committee on Drug Dependence". World Health Organization. Archived from the original on January 7, 2005. Retrieved 12 January 2014.
  23. SSRN 3932639 – via SSRN. {{cite journal}}: Cite journal requires |journal= (help
    )
  24. ^ EMCDDA, ELDD Comparative Study, May 2002.
  25. ^ "Marinol – the Legal Medical Use for the Marijuana Plant". Drug Enforcement Administration. Archived from the original on 21 October 2002. Retrieved 20 April 2011.
  26. ^ Alchimia Blog, Marijuana and Medicine: Cesamet, Marinol, Sativex
  27. ^ Dec 30, 2020, AP News, Tetra Bio-Pharma Files New Drug Submission for REDUVO™ in Canada
  28. ^ TBP Dec 16, 2020, Tetra Bio-Pharma Hits Another Milestone Before Year End: Inhaled Dronabinol & MucoAdhesive Dronabinol 'Adversa™'
  29. ^ Downs D (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.
  30. ^ Eustice C (12 August 1997). "Medicinal Marijuana: A Continuing Controversy". About.com. Archived from the original on 15 June 2011. Retrieved 20 April 2011.
  31. PMID 26836472
    .
  32. PMID 6269680
    .
  33. S2CID 6858360
    .
  34. ^ MARINOL (dronabinol) capsule drug label/data at DailyMed from U.S. National Library of Medicine, National Institutes of Health.
  35. ISBN 978-0-13-048118-4
    .
  36. ^ Greenberg G (1 November 2005). "Respectable Reefer". Mother Jones. Retrieved 8 April 2010.
  37. ^ "Cannabis and Cannabinoids (PDQ)". Cancer Topics. National Cancer Institute, U.S. Department of Health and Human Services. 2011-03-16.
  38. ^ "Government eases restrictions on pot derivative". Online Athens. Archived from the original on 2014-12-16. Retrieved 12 January 2014.
  39. ^ "21 CFR — SCHEDULES OF CONTROLLED SUBSTANCES §1308.11 Schedule I." Archived from the original on 2009-08-27. Retrieved 2021-01-10.

External links

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