Marijuana mouth spray seeks FDA approval for pain
Sativex, is a cannabinoid medicine for the treatment of multiple sclerosis (MS) symptoms, cancer pain, and neuropathic pain developed by GW Pharmaceuticals. Sativex could be approved in the U.S. as a treatment for pain relief in the next few years.
The British pharmaceutical company is currently testing the drug, which is delivered as a mouth spray, in clinical trials. The company plans to seek FDA approval of the drug for the treatment of cancer pain when the trails conclude in 2014, according to myhealthnewsdaily. Currently, Sativex is approved in the U.K., Spain, Germany, Denmark, New Zealand and Canada.
Sativex has a low risk for abuse, according to experts, because any “high” that a patient could receive is delayed compared to traditional smoking methods of marijuana ingestion on the street. Cultural norms that take place in stoner circles may demand the smoking method. Although some may consider this naive conjecture, the assumption is based on the low abuse rate of similar synthetic cannabinoids that have been on the market in the U.S. for several decades.
Sativex is the first marijuana-based drug to be made by extracting the compounds from the plant, rather than synthesizing them, which is the case in two other drugs, Marinol and Cesamet that were approved by the FDA in the 1980s. These two drugs have had low rates of abuse in the past.
Patients can adjust the dose of Sativex to prevent it from entering the blood steam too rapidly, allowing them to experience symptom relief without the high, says GW Pharmaceuticals. Furthermore, the drug is made up mostly of two ingredients: THC and another cannabinoid called CBD, the latter of which is known to meliorate some of the side effects of THC, such as the high that marijuana users feel.