Research Advances

While research has until recently been sharply limited by federal prohibition, the last few years have seen rapid change. The International Cannabinoid Research Society was formally incorporated as a scientific research organization in 1991. Membership in the Society has more than tripled from about 50 members in the first year to over 300 in 2005. The International Association for Cannabis as Medicine (IACM) was founded in March 2000. It publishes a bi-weekly newsletter and the IACM-Bulletin, and holds a bi-annual symposium to highlight emerging research in cannabis therapeutics. The University of California established the Center for Medicinal Cannabis Research in 2001. As of June 2006, the CMCR has 17 approved studies, including research on cancer pain, nausea control in chemo-therapy, general analgesia and a proposed study on refractory cancer pain.

In the United Kingdom, GW Pharmaceuticals has been granted a clinical trial exemption certificate by the Medicines Control Agency to conduct clinical studies with cannabis-based medicines. The exemption includes investigations in the relief of pain of neurological origin and defects of neurological function in the following indications: multiple sclerosis (MS), spinal cord injury, peripheral nerve injury, central nervous system damage, neuroinvasive cancer, dystonias, cerebral vascular accident and spina bifida, as well as for the relief of pain and inflammation in rheumatoid arthritis and also pain relief in brachial plexus injury.

GW has completed Phase III studies in patients with MS neuropathic pain and spasticity, and Phase II trials on perioperative pain, rheumatoid arthritis, peripheral neuropathy secondary to diabetes mellitus or AIDS, and patients with neurogenic symptoms.

These trials have provided positive results and confirmed an excellent safety profile for cannabis-based medicines. In 2002, GW conducted five Phase III trials of its cannabis derivatives, including a double-blind, placebo-controlled trial with a sublingual spray containing THC in more than 100 patients with cancer pain. In total, more than 1,000 patients are currently involved in phase III trials in the UK.

In 2002 GW Pharmaceuticals received an IND approval to commence phase II clinical trials in Canada in patients with chronic pain, multiple sclerosis and spinal cord injury, and in April 2005 GW received regulatory approval to distribute Sativex in Canada for the relief of neuropathic pain in adults with Multiple Sclerosis. Following meetings with the FDA, DEA, the Office for National Drug Control Policy, and the National Institute for Drug Abuse, GW was granted an import license from the DEA and has imported its first cannabis extracts into the U.S., and in January of 2006 was granted permission to begin Phase III clinical trials into cancer pain.