The U.S. Food and Drug Administration has given “Fast Track” designation to Sativex – a medical marijuana spray – for the treatment of pain in patients with advanced cancer. The move will expedite an FDA review of Sativex, which is currently in a Phase III clinical study for cancer pain.
“The award of Fast Track designation for Sativex represents important recognition by the FDA of the potential of this medicine to address significant unmet needs in the treatment of cancer pain,” said Justin Gover, CEO of British-based GW Pharmaceuticals (NASDAQ: GWPH), which is developing Sativex in the U.S. in collaboration with Otsuka Pharmaceutical Co. Ltd.
“Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications. We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn.”
Sativex is composed primarily of two cannabinoids: CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol), which are administered in an oromucosal spray called nabixmols.
Sativex is already being sold in Europe, Canada and Mexico to treat muscle spasticity caused by multiple sclerosis (MS). Canada also allows Sativex to be used for relief of neuropathic pain and advanced cancer pain. The spray is not currently approved for use in the U.S. for any condition.
The FDA’s decision to speed up the review process for Sativex is the latest indication that medical marijuana is gaining broader acceptance among patients, healthcare providers and the medical establishment.
Last month the American Academy of Neurology became one of the first medical organizations in the U.S. to endorse the use of medical marijuana. The Academy, which represents over 27,000 neurologists, issued new guidelines saying that oral cannabis, medical marijuana pills and medical marijuana spray may help ease pain and other symptoms caused by MS.
Initial data from the Phase III study on cancer patients is expected around the end of 2014. It is estimated that 420,000 cancer patients in the U.S. suffer from pain that is not well controlled by opioid pain medications.
A 2012 study of Sativex found a 26% improvement in pain among cancer patients who received a low dosage of nabixmols. Patients receiving low and medium doses of nabiximols also said they slept better. No significant improvement in pain was seen in patients in a high dosage group, who also didn’t tolerate the high dose well. Side effects included nausea and loss of cognitive function.
Opioid therapy is the standard treatment for cancer patients in pain. However, a significant number of patients continue to experience pain that isn’t controlled effectively at safe and tolerable opioid doses.
A recent online survey of over 1,300 fibromyalgia patients conducted by the National Pain Foundation found that medical marijuana is far more effective than any of the three prescription drugs approved by the FDA to treat fibromyalgia.
A spokesman for GW Pharmaceuticals told National Pain Report the company is not currently seeking FDA approval of Sativex as a treatment for fibromyalgia.
GW is developing other cannabinoid medicines to treat epilepsy, glioma, ulcerative colitis, type-2 diabetes, and schizophrenia.