FDA lets drugmaker test cannabis-based pain spray
January 04, 2006
George E. Jordan, Star-Ledger (NJ)
Proponents of medical marijuana got a boost yesterday when the Food and Drug Administration gave a British drugmaker permission to test a cannabis-derived treatment for cancer pain.
GW Pharmaceuticals was given permission to start a Phase III clinical trial in the United States for Sativex, an oral spray for use by seriously ill patients. The company said it may file for FDA approval as early as 2008.
Currently, sufferers of severe cancer pain have only a handful of narcotic pain medications, such as morphine, oxycodone, hydromorphone and fentanyl. They have potentially serious side effects in up to 60 percent of patients.
Founded in 1998, GW is attempting to develop a portfolio for prescription cannabis-based medications for multiple sclerosis, neuropathic pain, spinal cord injury, cancer pain and rheumatoid arthritis. Sativex is the company's first compound.
The company said it grows marijuana in a greenhouse at a secret location in the south of England. It said its medicines would be administered as sprays or tablets, not the customary method of smoking a hand-rolled cigarette. "Smoking is not an acceptable means of delivery for a medicine," the company said.
Federal law prohibits the use of marijuana, but several states -- Maine, Vermont, Alaska, California, Colorado, Hawaii, Montana, Nevada, Oregon and Washington -- allow it to be grown and used for medicinal purposes. The Rhode Island Legislature on Tuesday overrode a veto to approve medical marijuana use.
In June, the U.S. Supreme Court ruled people who smoke marijuana because their doctors recommend it could be prosecuted under federal drug laws, even if their states allow it. Federal authorities, however, have conceded they are unlikely to prosecute many medicinal marijuana users.