cannabis based pharmaceuticals

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Pharmaceutical Drugs Based on Cannabis

Pharmaceutical drugs have been developed which either contain or have similar chemicals as those found in the marijuana (cannabis) plant. Some researchers have used their understanding of how the brain processes cannabinoids to develop drugs which follow the same pathways but work differently than marijuana.

Pharmaceutical drugs based on marijuana are divided into four categories and listed below with the names, trade names, manufacturers, approval status, suggested medical use and cannabis-related properties. All drugs referenced are in pill form unless otherwise noted.

Drugs that contain chemicals taken directly from the marijuana plant

Drugs that contain synthetic versions of chemicals naturally found in marijuana

Drugs that contain chemicals similar to those in marijuana but not found in the plant

Drugs that do not work like marijuana but use the same brain pathways

I. Drugs that contain chemicals taken directly from the marijuana plant
Name/Trade Name Manufacturer Approval Status Suggested Medical Use Cannabis-Related Properties
1. Sativex GW Pharmaceuticals U.S. Phase III clinical trials started in late 2006
Approved for use in Canada (2005) and Catalonia, Spain (2005); Licensed to Bayer in the UK and to Almirall in Europe

Ongoing Phase III MS (Multiple Sclerosis) study in the UK due to report results in the first quarter (Q1) of 2009 and regulatory submission scheduled by the end of the second quarter (H1) in 2009.
Treatment of neuropathic pain and spasticity in patients with Multiple Sclerosis (MS); Analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain. Mouth spray whose chemical compound is derived from natural extracts of the cannabis plant

II. Drugs that contain synthetic versions of chemicals naturally found in marijuana
Name/Trade Name Manufacturer Approval Status Suggested Medical Use Cannabis-Related Properties
1. Dronabinol/
Marinol Unimed Pharmaceuticals,
a subsidiary of Solvay Pharmaceuticals FDA approved in United States as an appetite stimulant (1992) and for nausea (1985)
Approved in Denmark for multiple sclerosis (Sep. 2003)

Approved in Canada for AIDS-related anorexia (Apr. 2000) and for nausea and vomiting associated with cancer chemotherapy (1988)
Treatment of nausea and vomiting for patients in cancer treatment; Appetite stimulant for AIDS patients; Analgesic to ease neuropathic pain in multiple sclerosis patients Synthetic Delta-9 THC

2. Dronabinol Metered Dose Inhaler (MDI)/
Marinol aerosol Solvay Pharmaceuticals Not approved for use as of Feb. 15, 2008

Phase II clinical trials in the United States completed Sep. 7, 2006
Treatment of nausea, vomiting, migraines, spasticity in MS patients, and neuropathic pain Human-made THC inhaler


III. Drugs that contain chemicals similar to those in marijuana but not found in the plant
Name/Trade Name Manufacturer Approval Status Suggested Medical Use Cannabis-Related Properties
1. Nabilone/
Cesamet Valeant Pharmaceuticals International Approved for use in the United States (1985), United Kingdom and Australia (1982), Canada (1981)
On May 15, 2006, the FDA approved safety labeling revisions for nabilone (Cesamet 1-mg capsules) to advise of warnings and precautions related to its use in the treatment of chemotherapy-related nausea and vomiting
Treatment of nausea and vomiting in patients undergoing cancer treatment Synthetic cannabinoid similar to THC

2. Dexanabinol Pharmos Not approved for use as of Feb. 15, 2008
The Phase III clinical trial involving 846 patients was completed in Dec. 2004; Pharmos said the drug failed to show statistically significant improvement in the late-stage clinical trial
Neuroprotective (protects brain from damage) for use after cardiac surgery
Regain memory and other high-level function following Traumatic Brain Injury (TBI)
Synthetic non-psychotropic cannabinoid which blocks NMDA receptors and COX-2 cytokines and chemokines

3. CT-3 (ajulemic acid) Atlantic Technology Ventures Not approved for use as of Feb. 15, 2008
Completed Phase I clinical trials as of July 2002

Phase II study began in May 2002 in Germany to test its analgesic properties in patients with neuropathic pain

Treatment of spasticity and neuropathic pain in MS patients Synthetic, more potent analog of THC metabolite THC-11-oic acid

4. PRS-211,375/
Cannabinor
and
Cannabinor Oral Pharmos Not approved for use as of Feb. 15, 2008
Phase II(a) trials began in the 2nd quarter of 2006 and continued as of Apr. 2007

In Jan. 2007, Pharmos reported that in a Phase 2a experimentally induced pain model, cannabinor failed to meet the primary endpoint of reducing capsaicin-induced pain
Anti-inflammatory

Treatment of pain Synthetic chemical that specifically binds to the brain's secondary cannabinoid receptor (CB2)
5. HU 308 Pharmos

(licensed from the Hebrew University of Jerusalem) Not approved for use as of Feb. 15, 2008
Demonstrated efficacy in pre-clinical laboratory studies
Treatment of hypertension
Anti-inflammatory
Synthetic chemical that specifically binds to the brain's secondary cannabinoid receptor (CB2)

6. HU 331 Cayman Chemical Not approved for use as of Feb. 15, 2008
Demonstrated efficacy in pre-clinical laboratory studies, and has finished pre-clinical toxicology studies

ProCon.org contacted Cayman Chemical by phone on Feb. 15, 2008; According to Cayman Chemical, no current studies were taking place although HU 331 was available for purchase by research institutions

Demonstrated efficacy in pre-clinical laboratory studies
Treatment of memory, weight loss, appetite, neurodegeneration, tumor surveillance, analgesia, and inflammation Synthetic chemical compound composed of central cannabinoid (CB1), peripheral cannabinoid (CB2), and non-CB receptor-mediated pharmacology


IV. Drugs that do not work like marijuana but use the same brain pathways
Name/Trade Name Manufacturer Approval Status Suggested Medical Use Cannabis-Related Properties
1. Rimonabant/
Acomplia Sanofi-Aventis Not approved for use as of Feb. 15, 2008
On June 13, 2007, an FDA advisory panel of outside experts unanimously recommended that the regulatory agency not approve the drug for sale in the United States

Sanofi-Aventis withdrew its FDA application following the rejection, but announced that they will re-submit rimonabant to the FDA at a future date

Approved in June 2006 for use in Europe, marketed in 18 countries; Also available in Argentina, Brazil, and Mexico
Anti-obesity Synthetic chemical that blocks endocannabinoids from being received in the brain, and, as a result, suppresses appetite.

2. Taranabant/
MK-0364 Merck Not approved for use as of Feb. 15, 2008
Merck is expected to submit the drug for FDA approval in 2008

In Phase III trials as of Jan. 8, 2008
Anti-obesity Targets receptors in the brain linked to appetite. Acts as a Cannabinoid receptor type 1 (CB1R) inverse agonist, blocking cannabinoid receptors in the brain, which suppresses appetite
2. URB597
or
KDS-4103 Cayman Chemical
and
Kadmus Pharmaceuticals Inc Not approved for use as of Feb. 15, 2008
Demonstrated efficacy in pre-clinical laboratory studies, and has finished pre-clinical toxicology studies

ProCon.org contacted Cayman Chemical by phone on Feb. 15, 2008; According to Cayman Chemical, no current studies were taking place although URB597 was available for purchase by research institutions

Treatment of pain (acute - post-surgical; inflammatory - arthritis; neuropathic - damaged nerve cells from shingles, H.I.V., diabetes), anxiety, and depression Increases the amount of endocannabinoids in the brain by blocking the natural process of deactivating them. The same process that deactivates endocannabinoids also blocks chemicals which regulate mood

3. O-3246 Not available Not approved for use as of Feb. 15, 2008
Demonstrated efficacy in pre-clinical laboratory studies
Treatment of spasticity in MS patients Increases the amount of anandamide, an endocannabinoid, by tricking the brain to produce more instead of uptaking what is already present

4. AM 281 Bachem (formerly Peninsula Laboratories) Not approved for use as of Feb. 15, 2008
Demonstrated efficacy in pre-clinical laboratory studies
Neuroprotective for use in association with septic shock Synthetic chemical that blocks the endocannabinoids from being received in the brain, regulating the flow of blood to the brain during
septic shock

http://medicalmarijuana.procon.org/v...ourceID=000883