PotShot

Firm helps get marijuana-based drug into trials
Michelle Miron | Kalamazoo Gazette | August 27, 2006

A cannabis-derived painkiller will undergo Phase III clinical trials in the United States beginning later this year, partly because of help from Kalamazoo life-sciences consulting firm Apjohn Group LLC.

The prescription drug, Sativex, was approved in January by the U.S. Food and Drug Administration for the Phase III trials, which represent the last stage of clinical research required before a company can apply for license to market.

The oral analgesic spray is produced by British technology firm GW Pharmaceuticals and is already being marketed in Canada by Bayer Healthcare AG.

Apjohn, the firm started in 2003 by former Pharmacia Corp. executive Donald Parfet and others, was hired by GW in early 2005 to help bring the drug closer to U.S. clinical trials.

``Apjohn played an extremely important role in helping GW prepare the documentation for the Investigational New Drug Application,'' said Mark Rogerson, GW's press and public-relations representative. ``(That) led to a very successful result from the Food and Drug Administration -- the agency's allowing us to go directly into pivotal Phase III trials.''

The drug is the first commercial cannabis (marijuana) -derived drug in the world. It's used in Canada to treat patients with multiple sclerosis, and current trials are targeted at patients with advanced cancer whose pain has not been relieved by opioid medications like morphine, according to GW.

More than 2,000 patients and subjects have been involved in Sativex clinical trials in Europe and elsewhere, Rogerson said. The drug was also recently approved for limited use in Spain.

GW projects that an application to market Sativex in the U.S. could be submitted within 24 to 36 months after U.S. trials begin.

``The time scale after that is up to the FDA,'' Rogerson said.

GW was founded in 1998 and also focuses on cannabis-derived pharmaceuticals for patients with spinal-cord injuries, rheumatoid arthritis, neuropathic pain and other conditions. Its operations encompass botanical research, cultivation, extraction, formulation and medication delivery.

Buzzby

GW Pharmaceutical might want you to believe that, but marijuana has been used medicinally for 5,000 years.

From the Schaffer Library of Drug Policy:

Cannabis sativa has been used therapeutically from the earliest records, nearly 5,000 years ago, to the present day (Mikuriya, 1969: 34) and its products have been widely noted for their effects, both physiological and psychological, throughout the world. Although the Chinese and Indian cultures knew about the properties of this drug from very early times, this information did not become general in the Near and Middle East until after the fifth century A.D., when travelers, traders and adventurers began to carry knowledge of the drug westward to Persia and Arabia.

Historians claim that cannabis was first employed in these countries as an antiseptic and analgesic. Other medical uses were later developed and spread throughout the Middle East, Africa, and Eastern Europe.

Several years after the return of Napoleon's army from Egypt, cannabis became widely accepted by Western medical practitioners. Previously, it had had limited use for such purposes as the treatment of burns. The scientific members of Napoleon's forces were interested in the drug's pain relieving and sedative effects. It was used during, and to a greater extent, following his rule in France, especially after 1840 when the work of such physicians as O'Shaughnessy, Aubert-Roche, and Moreau de Tours drew wide attention to this drug.

With the rise of the literary movement of the 1840-1860 period in France (Gautier, Baudelaire, Dumas, etc.), cannabis became somewhat popular as an intoxicant of the intellectual classes.

In the United States, medical interest in cannabis use was evidenced in 1860 by the convening of a Committee on Cannabis Indica of the Ohio State Medical Society, which reported on its therapeutic applications (McMeens, 1860: 1). Between the period 1840-1890, Walton states that more than 100 articles were published recommending cannabis for one disorder or another.

During the 19th Century, pharmacy shelves were stocked with dozens of cannabis-derived drugs.

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