The tug-of-war between advocates for the use of medicinal cannabis and politicians who see it as a slippery slope, that ultimately leads to the legalization of marijuana, now have Sativex® that promises to heat up the discussion. The medication has shown to be effective in the treatment of pain in cases where conventional opioid medications (codeine, morphine, etc.) have not shown to be a worthy treatment.
Sativex® is a spray made from the extract of two chemovars of cannabis. Tetrahydrocannabinol (THC) is the primary element and the other element is cannabidol, which contains the plant’s full range of natural phytocannabinoids and terpenoids. Before anyone gets hot and heavy about the ‘high’ of the elements used, a study found that those test subjects who received a placebo experienced no greater intoxication scores than those who received the cannabis derivative, Sativex®.
In 2005, Canada gave Sativex® approval status under their Notice of Compliance with Conditions, which requires the manufacturer to pursue further clinical trials. This decision was based, in part, on studies for the medication done in Europe. Because of Canada’s approval, and the European studies, the Federal Drug Administration (FDA) has fast tracked the approval process to allow clinical trials I & II to be by-passed and to begin phase III clinical trials. Some view the FDA’s move as a possible shift away from politically motivated decisions and toward decisions based on good scientific and medical judgment.
GW Pharmaceuticals manufactures Sativex® and in Canada markets it by Bayer HealthCare. The efficacy studies primarily focus on reducing multiple-sclerosis (MS) pain. Approximately 17 to 52% of people with MS experience pain related symptoms, and of those, 32% say it is their worst symptom for the disease. Patient’s cancer pain will also be studied, but pain relief for other conditions have already been noticed, like rheumatoid arthritis pain, allodynia (severe pain from stimuli that are normally painless–caused by damage to the central nervous system (CNS), and brachial plexus pain–pain caused from damage of the nerves that conduct signals from the spine to the shoulder, arm and hand.
Currently there are numerous clinical trials recruiting for studies related to the use of Sativex® and pain control.