Salisbury, United Kingdom: British biotechnology firm GW Pharmaceuticals announced this week that it is accelerating plans to seek US regulatory approval for its oral spray Sativex, a whole plant medicinal cannabis extract containing precise doses of the cannabinoids THC and cannabidiol (CBD).
According to published reports by Reuters News Wire, the company has retained the services of the Apjohn Group, a 10-member organization consisting of former US pharmaceutical company executives specializing in US clinical drug development, regulatory affairs, and public policy. The company is also considering applying for an Investigational New Drug (IND) application from the US Food and Drug Administration (FDA).
In clinical trials, Sativex has been shown to reduce cancer pain and MS-associated spasticity, among other symptoms, in patients unresponsive to standard therapies.
Last December, Health Canada issued a “Qualifying Notice” for the approval of Sativex for the treatment of neuropathic pain associated with Multiple Sclerosis. However, British regulatory approval for the drug has been delayed after an advisory body of the British Medicines and Health products Regulatory Agency (MHRA) announced late last year that it required further clinical evidence of Sativex’s ability to alleviate MS-associated spasticity in a “clinically relevant” manner.
For more information, please contact Allen St. Pierre or Paul Armentano of NORML at (202) 483-5500 or visit: http://www.gwpharm.com