New Canadian drug submission for cannabis-based medicine

GW Pharmaceuticals and Bayer HealthCare, Pharmaceuticals Division - Canada have announced that GW has submitted a New Drug Submission for Sativex®, a cannabis-based medicinal extract product, to Health Canada.

Sativex has been developed by GW and, subject to approval, will be exclusively marketed in Canada by the Pharmaceuticals Division of Bayer HealthCare.

Sativex has been developed to provide a cannabis-derived pharmaceutical product for the treatment of the debilitating symptoms of Multiple Sclerosis (“MS”) and severe neuropathic pain. The product is a whole plant medicinal cannabis extract containing TetranabinexTM (tetrahydrocannabinol or THC) and NabidiolexTM (cannabidiol or CBD) as its principal components. The medicine is administered by means of a spray into the mouth.

Approximately 50,000 people in Canada are diagnosed with Multiple Sclerosis. Pain is a common symptom in MS and significant pain occurs in 42–65% of all MS patients.1 A survey of Canadian patients with neuropathic pain cited a 72.8% finding of inadequate pain control.2

Dr Geoffrey Guy, Executive Chairman of GW, said, “In recent years, GW has conducted an active and positive dialogue with Canadian officials regarding the introduction of Sativex. Subject to regulatory approval, we now look forward to bringing a non-smoked, cannabis-based prescription medicine to market in Canada.”

Philip Blake, President of Bayer Inc., said, “We are very pleased to be working in partnership with GW to bring this innovative medicine to the Canadian market once it has been approved. MS patients often suffer from pain associated with this disease. We hope that Sativex offers another treatment option.”

GW submitted a product licence application for Sativex to the UK Medicines and Healthcare products Regulatory Agency in March 2003. http://www.gwpharm.com/

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