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Pharmaceutical giant Bayer HealthCare has applied to market a marijuana-based drug in Canada. If approved, it would be the first cannabis-based drug legally available in this country for the relief of debilitating symptoms of multiple sclerosis and severe neuropathic pain.
Bayer and GW Pharmaceuticals of Britain announced Tuesday they had filed a new drug submission to Health Canada for Sativex, an oral spray developed by GW Pharmaceuticals and licensed to Bayer.
A spokesperson for Health Canada said it typically takes about 18 months for the department's therapeutic products directorate to review and rule on a submission.
Bayer's vice-president for public policy and communication said the companies are confident, based on early discussions with the department, that the submission will be approved.
"It's our belief through our initial discussions that we hope to get it through the regulatory process, and in as quick time as possible," Doug Grant said Tuesday.
"You can never tell with any drug once it gets into the regulatory process, but they have been quite open in discussing this with us."
The companies describe the product as a whole plant medicinal cannabis extract containing tetrahydrocannabinol, or THC, and cannabidiol as its principal components.
There are other cannabis-based drugs available in this country. They are used by cancer and AIDS patients to control nausea and vomiting and to restore appetite as a means of combating the wasting effect of those diseases.
But Sativex would be the first cannabis-derived drug aimed at MS sufferers.
The head of the MS clinic at St. Michael's Hospital in Toronto said if the drug is approved, it would be a welcome addition to the arsenal of drugs available to alleviate the pain and spasticity experienced by many patients with MS.
While there are other, non-cannabis based drugs on the market to treat those symptoms of the disease, "there remains a subgroup of MS patients who don't respond well or at all to the anti-pain, anti-spasticity drugs. And that group would want to try this," said Dr. Paul O'Connor, a neurologist.
"If it became an approved medication by the federal government, I would certainly want to try it in certain patients and get some first-hand experience as to how it works."
O'Connor said some of his patients use marijuana to control these debilitating symptoms.
But users of medicinal marijuana complain the product available by prescription from the federal government is of poor quality. And O'Connor said many patients don't want to smoke.
"A lot of the patients that do smoke it wish that there was a more convenient and non-smokeable but effective form of a cannabinoid available," he said.
Approximately 50,000 people in Canada are diagnosed with MS.
British regulatory authorities are already working on a drug approval submission for Sativex. Grant said the companies hope to have approval shortly and to have the product on the market there by the end of this year.
Source: Canadian Press
Published: May 11, 2004
Copyright: 2004 The Canadian Press
Bayer and GW Pharmaceuticals of Britain announced Tuesday they had filed a new drug submission to Health Canada for Sativex, an oral spray developed by GW Pharmaceuticals and licensed to Bayer.
A spokesperson for Health Canada said it typically takes about 18 months for the department's therapeutic products directorate to review and rule on a submission.
Bayer's vice-president for public policy and communication said the companies are confident, based on early discussions with the department, that the submission will be approved.
"It's our belief through our initial discussions that we hope to get it through the regulatory process, and in as quick time as possible," Doug Grant said Tuesday.
"You can never tell with any drug once it gets into the regulatory process, but they have been quite open in discussing this with us."
The companies describe the product as a whole plant medicinal cannabis extract containing tetrahydrocannabinol, or THC, and cannabidiol as its principal components.
There are other cannabis-based drugs available in this country. They are used by cancer and AIDS patients to control nausea and vomiting and to restore appetite as a means of combating the wasting effect of those diseases.
But Sativex would be the first cannabis-derived drug aimed at MS sufferers.
The head of the MS clinic at St. Michael's Hospital in Toronto said if the drug is approved, it would be a welcome addition to the arsenal of drugs available to alleviate the pain and spasticity experienced by many patients with MS.
While there are other, non-cannabis based drugs on the market to treat those symptoms of the disease, "there remains a subgroup of MS patients who don't respond well or at all to the anti-pain, anti-spasticity drugs. And that group would want to try this," said Dr. Paul O'Connor, a neurologist.
"If it became an approved medication by the federal government, I would certainly want to try it in certain patients and get some first-hand experience as to how it works."
O'Connor said some of his patients use marijuana to control these debilitating symptoms.
But users of medicinal marijuana complain the product available by prescription from the federal government is of poor quality. And O'Connor said many patients don't want to smoke.
"A lot of the patients that do smoke it wish that there was a more convenient and non-smokeable but effective form of a cannabinoid available," he said.
Approximately 50,000 people in Canada are diagnosed with MS.
British regulatory authorities are already working on a drug approval submission for Sativex. Grant said the companies hope to have approval shortly and to have the product on the market there by the end of this year.
Source: Canadian Press
Published: May 11, 2004
Copyright: 2004 The Canadian Press
