The active ingredients in cannabis are Cannabinoids and the most potent ones are Tetrahydrocannabinol (THC) and Cannabinadiol (CBD). GWP has separated various Cannabinoids to determine which work best for specific ailments. Clinical trials have shown, for instance, that appetite was most improved with pure THC, but CBD also had an effect. They found the THC/CBD mix to work especially well for sleep improvement.
"We're seeing time and time again that CBD's have something to contribute," Dr. Ethan Russo told attendees at the recent NORML Conference in San Francisco. "I've been harping on this for years, but I think we finally have definitive proof of this concept."
While activists welcome the sublingual spray's medical efficacy, the delivery system has become fairly controversial.
The device designed for the British market is a simple spray bottle with no controls because, as Russo noted, "people over there do as they're told."
In order to gain approval by the FDA and DEA, however, GWP has developed the "Advanced Delivery System" (ADS) for the American market.
With it, the liquid or solid drug is contained in a cartridge that pops into a failsafe, access-coded device with Big Brotherish features such as a quantity monitor that reports to doctors on how high the patient is getting.
"In the US, this is how it will be," Russo resignedly stated.
Dr. Lester Grinspoon, retired Professor Emeritus of Harvard Medical School, has decidedly less enthusiasm for the ADS spray device. He criticizes its controls of titration, that is, how the patient incrementally increases the dosage necessary for symptomatic relief.
"The device prevents delivery if the patient tries to take more than the physician or pharmacist has set and it also can be set so that you can't get any response during certain hours. That is not titration," he told the NORML members. "The purpose of using this cumbersome and expensive device apparently reflects a concern that patients can not accurately titrate the therapeutic amount, or a fear that they might take more than they need and experience some degree of high, always assuming that the two can easily be separated."
GW Pharmaceuticals has submitted findings for three years of research on the sublingual cannabis extract and may gain approval from the British Government by the end of this year.
On May 21, GW Pharmaceuticals announced their exclusive agreement with German drug giant Bayer AG to market the cannabis-based extracts, which will be sold under the brand name Sativexr.
Elsewhere, the Israeli company Pharmos has created a neuroprotective product called Dexanabinol for the treatment of head trauma and stroke, and recently gained approval from the US government for a Phase III trial in the US, the first of its kind in this country.
Data from a recent German study on smoked marijuana's effects on Tourette's Syndrome shows that ingestion of pure THC resulted in a significant improvement of tic severity. In Spain, there are studies on how compounds in marijuana alleviate certain types of brain tumors.
At least 10 California state-funded trials are ongoing at UC San Francisco and San Diego investigating whole smoked marijuana's effects on HIV-related neuropathy, Multiple Sclerosis and analgesia. These institutions are working jointly with the New York State Psychiatric Institute comparing oral THC on patients with HIV/Aids.
Until the day when marijuana pharmaceuticals become available here, doctors overwhelmingly recommend the use of a vaporizer over pipes, joints, bongs and water pipes. The benefits include a novel means of delivery as well as the near-total elimination of carbon monoxide and tars.
The German-made Volcano is considered "the Cadillac of vaporizers." It's designed to heat material to temperatures of 130 to 230 Celsius where medically active vapors are produced, but below the threshold of combustion. This conically-shaped electric heat source zaps the sticky, cannabinoid-rich resin into vapor and blows it into a turkey baking bag that is secured by a press release nozzle. A patient can walk around sucking on this balloon o' vapor all day and the vapor stays potent even if left in the bag overnight.
A recent study in Massachusetts showed that the Volcano vapor was remarkably clean and consisted 95 percent of THC with traces of Cannabinol (CBN). The remaining 5 percent consisted of small amounts of three other components. In contrast, over 111 different components appeared in the gas of the combusted smoke, including a half-dozen known Polycyclic Aromatic Hydrocarbons (PAH).