Multiple sclerosis patients who use an oral cannabinoid spray showed no long-term cognitive impairment or changes in mood, according to a new study released by GW Pharamaceuticals, a British biopharmaceutical company.
The spray, sold under the brand name Sativex, is approved for use in Europe, Canada and Mexico to treat multiple sclerosis (MS) symptoms and cancer pain, but is currently not approved for sale in the United States. GW Pharmaceuticals hopes to see FDA approval by the end of 2013.
“We are pleased to report positive and wholly reassuring results from this 12 month placebo-controlled study in patients with MS spasticity,” said Dr. Stephen Wright, GW Pharmaceuticals research and development director.
“We have now shown that Sativex does not impair cognition either in short-term or in long-term use in well designed, randomized, placebo controlled clinical trials. These data not only confirm the good tolerability of Sativex in long-term use but also provide further evidence of efficacy consistent with that seen in previous shorter duration clinical trials.”
The double-blind study followed 121 patients in Britain with MS spasticity over a 12-month period. The study was required by UK health officials to evaluate whether Sativex may have long term adverse effects on cognitive function or mood. Sativex contains a formulation of cannabinoids, marijuana’s most active ingredients.
There was a slight improvement in cognitive function from the beginning to the end of the study in both the Sativex and placebo groups, according to the company. Changes in mood over the 12 month period were more or less identical in the Sativex and the placebo group, confirming no untoward effect on mood.
Spasticity is one of the most common symptoms of MS, occurring in up to 75% of patients. It is characterized by muscle spasms, stiffness and difficulty in moving muscles. Spasticity effects a patient’s ability to walk, move, and sleep, and is considered one of the main factors contributing to disability.
Multiple sclerosis is a chronic disease which attacks the body’s central nervous system and destroys the myelin sheath that protects the nerve cells. An estimated 400,000 Americans have the disease and more than 2 million worldwide.
GW Pharmaceuticals, which was recently listed on the NASDAQ stock exchange under the symbol GWPH, said it was making progress in its bid to enter the lucrative American market, having submitted plans for a final MS clinical trial to the Food and Drug Administration.
Sativex is also in Phase III clinical development as a potential treatment for people in pain from advanced cancer. The Phase 3 study is intended to lead to the submission of a new drug application for Sativex to treat cancer pain with the FDA. The company is targeting the 20 percent patients who do not respond to narcotic painkillers. Results from that study are expected in 2014.
GW Pharmaceuticals is also developing cannabinoid products to treat Type 2 diabetes, epilepsy, ulcerative colitis and schizophrenia.
“As we move forward in the second half of 2013, we expect a significant amount of clinical activity to occur with respect to our cannabinoid pipeline candidates,” said Justin Gover, CEO of GW Pharmaceuticals.
The company reported a loss $3.1 million in the third quarter. The company ended the quarter with a record $66 million in cash, much of it raised by its IPO in the U.S.
“We expect to generate a significant portion of our future revenues in United States and providing greater exposure for the company to the U.S. investment community is a key goal for GW moving forward,” Gover said.