GW Pharmaceuticals, the maker of the sublingual, cannabis-based spray medication Sativex, announced Wednesday that it won US Food and Drug Administration (FDA) approval to proceed with Phase III clinical trials of the drug's efficacy in patients suffering from pain from advanced cancers. The FDA has accepted GW's bid to study the drug under its Investigational New Drug (IND) program.
Sativex is already on the market in Canada and has been approved for use in Spain, but its bid to win acceptance in Britain stumbled recently when an elderly women participating in Sativex trials died. The FDA based its approval in part on data generated by GW on Sativex in Europe.
The planned 250-patient study will evaluate the effects of Sativex in relieving average daily, reducing the use of opioid pain medications, and improving the quality of sleep and other quality of life indicators among patients.
"A previous Phase III clinical study showed that Sativex achieved a statistically significant improvement in pain relief in terminally ill cancer patients," said researcher, Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative \Care at Beth Israel Medical Center in New York City. "Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex will be critical in defining their role."
"Sativex seems to be a very promising treatment option for patients whose pain does not respond to current analgesics," said Dr. Nathaniel Katz, Assistant Professor of Anesthesia, Tufts University School of Medicine. "The clinical data thus far suggest that many patients who have been suffering with intractable pain may gain significant benefit from the use of Sativex. I welcome GW expanding its research program into the US."
GW stockholders and chronic pain patients may indeed welcome the FDA's approval of Sativex trials as one more step in bringing the drug to market in the US. But advocates of raw, smoked medical marijuana also worry whether approval of a cannabis-based medicine could cut the legs out from under the medical marijuana movement.