Ottawa, Ontario: Health Canada granted preliminary regulatory approval this week to Sativex, an oral spray consisting of natural cannabis extracts, for the treatment of advanced cancer pain.
The agency issued a Qualifying Notice for the cannabis-based drug, confirming that it qualifies to be considered for regulatory approval. Final approval is expected within approximately 60 days.
Sativex is already available in Canada by prescription for the treatment of pain associated with multiple sclerosis. Regulators in Great Britain and Spain have also granted limited regulatory approval for the drug.
Produced by the British biotechnology firm GW Pharmaceuticals, Sativex is a whole plant medicinal cannabis extract containing precise doses of the cannabinoids THC and cannabidiol (CBD), as well as naturally existing terpenoids and flavonoids.
Last year, the US Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for Sativex to enter into Phase III clinical trials in the US for the treatment of cancer pain. The first US trial is expected to begin later this year.
For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at: paul@norml.org or visit: http://www.gwpharm.com.