Pharmaceutical Drugs Based on Cannabis

A sample of those pharmaceutical drugs based on marijuana are listed below with their names, trade names, manufacturers, cannabis-related properties, suggested medical uses, and approval statuses.

Sativex oral spray  Source: “Medical Marijuana aka Sativex Now Available in UK,” examiner.com, June 19, 2010

Cannabis-Related Properties
Mouth spray whose chemical compound is derived from natural extracts of the cannabis plant. Sativex contains two cannabinoids: THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol).

Suggested Medical Use
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.

Approval Status
Approved and launched in the UK on June 21, 2010, making it the first cannabis-based prescription medicine in the world (rescheduled from UK Schedule 1 to Schedule 4 on Apr. 10, 2013). Licensed to Bayer in the UK and to Almirall in Europe. Approved to treat spasticity caused by multiple sclerosis in Spain (July 28, 2010), Canada (Aug. 31, 2010), Czech Republic (Apr. 15, 2011), Denmark (June 8, 2011), Germany (July 4, 2011), Sweden (Dec. 22, 2011), Austria (Feb. 7, 2012), Italy (May 7, 2013), and Switzerland (Nov. 27, 2013). Also approved in Finland, Israel, Norway, and Poland.

In the US, Phase III clinical trials started in late 2006 for treatment of pain in cancer patients and were in recruitment in 2013. On Apr. 20, 2011, a US patent was granted for Sativex in cancer pain. As of Apr. 28, 2014, Sativex was still in Phase 3 clinical development to treat pain in cancer patients, and the company expects to see results from the program at the end of 2014. On Apr. 28, 2014, the FDA granted “Fast Track” designation to Sativex for the treatment of pain in patients with advanced cancer. The FDA website says that “Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.”

GW Pharmaceuticals worked with US licensing partner Otsuka Pharmaceutical to open a Phase III Investigational New Drug application in the United States to treat spasticity due to Multiple Sclerosis on Aug. 14, 2013. On Jan. 8, 2015, GW Pharmaceuticals announced that in the first of three US Phase 3 trials for treatment of pain in patients with advanced cancer, Sativex “did not meet the primary endpoint of demonstrating a statistically significant difference from placebo.” Two additional Phase 3 trials are in progress in 2015.

Marinol Source: “Cannabis, Coca, & Poppy: Nature’s Addictive Plants,” deamuseum.org (accessed Nov. 12, 2013)

Cannabis-Related Properties
Synthetic Delta-9 THC.

Suggested Medical Use
Treatment of nausea and vomiting for patients in cancer treatment; appetite stimulant for AIDS patients; analgesic to ease neuropathic pain in multiple sclerosis patients.

Approval Status
FDA approved in United States as Schedule I drug for appetite stimulation (1992) and for nausea (1985); moved to Schedule III effective July 2, 1999.

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).

Cannabis-Related Properties
Synthetic cannabinoid similar to THC.

Suggested Medical Use
Treatment of nausea and vomiting in patients undergoing cancer treatment.

Approval Status
Originally approved by the FDA for use in the US in 1985, but removed from the market until re-approved by the FDA on May 15, 2006 and made available in US pharmacies on Aug. 17, 2006. Also approved in United Kingdom and Australia (1982), Canada (1981), and Mexico (2007).

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, such as its potential to affect the mental state of a patient. On Feb. 22, 2007, Valeant announced the submission of an Investigational New Drug application to test Cesamet as a treatment for chemotherapy-induced neuropathic pain.

Cannabis-Related Properties
Synthetic non-psychotropic cannabinoid that blocks NMDA receptors and COX-2 cytokines and chemokines.

Suggested Medical Use
Neuroprotective (protects brain from damage) for use after cardiac surgery; regain memory and other high-level function following Traumatic Brain Injury (TBI); possible future use as an anti-cancer drug.

Approval Status
Not approved for use as of Nov. 11, 2013.

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; A Phase I study to test for the treatment of brain cancer began in Sep. 2012.

Cannabis-Related Properties
Synthetic, more potent analog of THC metabolite THC-11-oic acid.

Suggested Medical Use
Treatment of spasticity and neuropathic pain in MS patients; anti-inflammatory properties may help relieve pain from arthritis.

Approval Status
Not approved for use as of Nov. 11, 2013.

Completed Phase I clinical trials as of July 2002.

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

Cannabis-Related Properties
Synthetic chemical that specifically binds to the brain’s secondary cannabinoid receptor (CB2).

Suggested Medical Use
Anti-inflammatory; treatment of chronic pain with an emphasis on neuropathic (nerve) pain; bladder control.

Approval Status
Not approved for use outside of laboratory research as of Nov. 11, 2013.

Phase II(a) trials began in the UK in the 2nd quarter of 2006. 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, but the drug was found to be safe.

Cannabis-Related Properties
Synthetic chemical that specifically binds to the brain’s secondary cannabinoid receptor (CB2).

Suggested Medical Use
Treatment of hypertension; anti-inflammatory.

Approval Status
Not approved for use outside of laboratory research as of Nov. 11, 2013.

Demonstrated efficacy in pre-clinical laboratory studies.

Cannabis-Related Properties
Synthetic chemical compound composed of central cannabinoid (CB1), peripheral cannabinoid (CB2), and non-CB receptor-mediated pharmacology.

Suggested Medical Use
Treatment of memory, weight loss, appetite, neurodegeneration, tumor surveillance, analgesia, and inflammation.

Approval Status
Not approved for use outside of laboratory research as of Nov. 11, 2013.

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.

Acomplia (rimonabant) Source: “Generic Drugs Online,” generic-line.com (accessed Nov. 12, 2013)

Cannabis-Related Properties
Synthetic chemical that blocks endocannabinoids from being received in the brain, and, as a result, suppresses appetite.

Suggested Medical Use
Anti-obesity (appetite reducer).

Approval Status
Not approved for use as of Nov. 11, 2013.

In Feb. 2006, the FDA issued an “approvable letter” for Acomplia as a weight loss drug, but also sent a “non-approvable letter” for the drug as a smoking cessation aid. The approvable letter meant that there was a potential for eventual approval, but issues had to be addressed that were not made public. 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 after it was linked with suicidal thoughts. Sanofi-Aventis withdrew its FDA application following the rejection.

The drug was approved in June 2006 for use in Europe and marketed in the European Union; approval withdrawn by European Medicines Agency on Jan. 16, 2006 due to potential psychiatric side effects. Sanofi-Aventis then removed from it the market.

Cannabis-Related Properties
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.

Suggested Medical Use
Anti-obesity.

Approval Status
Not approved for use as of Nov. 11, 2013.

Merck started Phase III trials in Jan. 2008 and was expected to submit the drug for FDA approval in 2008. In Oct. 2008, Merck announced that the side effects from taranabant, including depression and anxiety, increased at higher doses, and therefore the company decided to stop development.