Sativex Seeks FDA Approval

Sativex THC spray

Marijuana has been used for numerous medical reason, but now a British pharmaceutical company, known as GW Pharma, has developed a mouth spray from key ingredients of raw marijuana to treat severe cancer pain.  The British company is in advanced clinical trials with the world’s first pharmaceutical developed from raw marijuana and it hopes to see FDA approval by the end of 2013.

GW Pharmaceuticals has asked the Food and Drug Administration to approve Sativex.  Sativex contains marijuana’s two best known components, delta 9-THC and cannabidiol, which have already has been approved in Canada, New Zealand and eight European countries for a different usage, relieving muscle spasms associated with multiple sclerosis.

The company lists the main effects of cannabinoids as anti-inflammatory, anticonvulsant, antipsycotic, anti-oxidant, neuroprotective, immunomodulatory, and the main effects of THC as analgesic, anti-spasmodic, anti-tremor, anti-inflammatory, appetite stimulant, anti-emetic. The most common side effects of Sativex are dizziness and fatigue.

Last April, the U.S. Patent and Trademark Office issued a notice of allowance for a patent, which protects the use of Sativex as a treatment for cancer pain, providing an exclusivity period until April 2025.  FDA approval would represent an important milestone in the nation’s often uneasy relationship with marijuana, which 16 states and the District of Columbia already allow residents to use legally with doctors’ recommendations.

The Department of Justice’s Drug Enforcement Administration shot down a petition to reclassify marijuana as a drug with important medicinal properties in July 2011, citing that it has “no accepted medical use.” Marijuana therefore remains within the strictest categorization of restricted substances, alongside heroin and LSD. (ANI)

Scientist, Alexandros Makriyannis, director of the Center for Drug Discovery at Northeastern University and founder of a small Boston company that hopes to market synthetic pain products that are chemically unrelated to marijuana, but work similarly on the body or inhibit the cannabinoid receptors. He also has been working on a compound that functions like the failed Acomplia but without the depressive effects.

“I think within five to 10 years, we should get something,” Makriyannis said.





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