Drug Company seeks FDA Approval for Marijuana Spray as Painkiller

Drug Company seeks FDA Approval for Marijuana Spray as Painkiller

Sativex is administered orally in a mouth spray. If given FDA approval, sales could begin in the U.S. by the end of 2013. Photo courtesy of GW.

A British pharmaceutical company hopes to begin selling the world’s first marijuana based prescription drug in the U.S. by the end of 2013. GW Pharmaceuticals has asked the Food and Drug Administration to approve the use of Sativex as a treatment for severe cancer pain.

Sativex is a mouth spray that contains a formulation of cannabinoids, marijuana’s most active ingredients. Sativex is already approved in Canada, New Zealand and eight European countries for relieving muscle spasms for patients with multiple sclerosis. Canada also allows Sativex to be used for relief of neuropathic pain and advanced cancer pain.

The FDA application seems likely to renew an old debate in the U.S. about marijuana’s medicinal value. Sixteen states allow residents to use marijuana legally for medical purposes, but the Drug Enforcement Agency still considers the plant a dangerous drug with no medical value. As recently as last year the DEA rejected a petition to reclassify marijuana as a drug, stating it has “no accepted medical use.”

GW Pharmaceuticals began research and development of cannabinoid prescription drugs in 1998. The company’s clinical research has been primarily focused on using Sativex to treat multiple sclerosis, cancer pain and neuropathic pain. But GW is now extending its research into new areas such as oncology, diabetes, epilepsy and psychiatric illness.

“There is no evidence to suggest that Sativex produces a ‘high’ comparable to recreational cannabis,” the company says in a statement on its website. “However as with all medicines, there is the potential for Sativex to cause unwanted effects such as dizziness or fatigue when it is first used.”

One of the cannabinoids in Sativex is the psychoactive molecule THC, which is responsible for the “buzz” that recreational users experience. The other principal cannabinoid is CBD, which is non-psychoactive. The drug company claims CBD modulates the “high” caused by THC. Paring the two together in a controlled dose administered orally also keeps THC from entering the blood too rapidly. Patients are able to experience pain relief without feeling intoxicated, according to the company.

GW Pharmaceutical’s marijuana plants are grown at a secret location in southern England. Photo courtesy of GW.

GW’s marijuana plants are grown in greenhouses at a secret location in southern England. For security reasons the company won’t  disclose the precise location.

Growing conditions in the greenhouses, including temperature, humidity and light, are all controlled by computer. Once cultivated, the cannabinoids are extracted from the marijuana and formulated to make Sativex.

Authored by: Pat Anson, Editor