"This is great news for those who can't get any relief from the most common drugs," Jan Hillert, an MS researcher at Karolinska Institute, told the Dagens Nyheter daily newspaper, reports The Local.
The agency said that it plans to closely monitor prescriptions for Sativex to ensure against abuse.
According to both the agency and Sativex manufacturer GW Pharmaceuticals, which grows medicinal cannabis and prepares the extract in Britain, the spray does not result in a "high" as the cannabinoids included -- a near 1:1 mix of tetrahydrocannabinol (THC) and cannabidiol (CBD) -- aren't administered in large enough doses.
|A plant from GW Pharmaceuticals' legal grow in the U.K.|
People suffering from MS, which damages the brain and the central nervous system, often experience problems with stiffness and muscle cramps.
Sativex spray, which is used sublingually (under the tongue), has been shown by a series of medical studies to be successful in alleviating MS symptoms.
"Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder or sleep disturbance," GW Pharmaceuticals said in a press release. "By relieving the symptoms of MS, Sativex® can improve patients' quality of life and allow them greater independence in performing their daily activities."
The cannabis spray is already available as a prescription medication in the United Kingdom, Germany, Spain, Denmark, Canada and New Zealand, according to GW. Last week, Sativex also received regulatory approval in Austria, where the product launch is expected to take place later this year following the completion of the national pricing and reimbursement process.
In addition to its approved use for MS, Sativex is also in Phase III clinical development as a treatment for cancer pain, according to GW.
Sativex will be marketed in both Sweden and Austria by GW's marketing partner, Almirall S.A. The extract is currently under regulatory review in Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.
Herbal medical marijuana is not illegal in Sweden, but getting a prescription for it is a lengthy and difficult process. The prescribing doctor is required to apply for a special permit from the Medical Products Agency and, if the prescription is approved, the closest pharmacy has to arrange for a special import from the Netherlands, where the Dutch-based company Bedrocan grows the legal medical cannabis supply for much of Europe.
According to some observers of the American medical marijuana scene, the current crackdown on medicinal cannabis dispensaries is part of a larger plan under which the pharmaceutical industry, specifically GW Pharmaceuticals -- which makes campaign contributions to the politicians responsible for regulating it -- would take over the industry with Sativex after the competition is cleared out of the way.
|GW's grow room facilities, above, are at an undisclosed location in the English countryside|