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.

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.

Newshawk: Ohio Patient Network http://www.ohiopatient.net/
Pubdate: Sun, 27 Aug 2006
Source: Kalamazoo Gazette (MI)
Copyright: 2006 Kalamazoo Gazette
Contact: letters@kalamazoogazette.com
Website: http://www.mlive.com/kzgazette/
Details: http://www.mapinc.org/media/588
Author: Michelle Miron