The Kalamazoo, Michigan based company Apjohn Group LLC is currently working with the British firm GW Pharmaceuticals to give U.S. patients access to the Sativex inhaler. The drug which is produced by GW Pharmaceuticals and available in Canada through Bayer, will begin Phase III trials in the U.S. Food and Drug Administration later this year.
The Sativex inhaler is a device that uses a cannabis (marijuana) derived painkiller that is delivered in the form of an oral analgesic spray. The drug is the first commercial cannabis 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 based medications like morphine, according to GW. The cannabis used in the Sativex inhaler does not contain the chemical THC (Tetrahydrocannabinol), the substance that causes intoxication.
The Apjohn Group LLC, 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. Over 2,000 patients have been involved in Sativex clinical trials in Europe, and has been 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.
For more information,
Apjohn Group LLC
http://www.apjohngroup.com/
GW Pharmaceuticals
http://www.gwpharm.com/