Positive preliminary results from a Phase II study of GW Pharmaceuticals’ chronic cancer pain drug Sativex should result in regulatory approval for the world’s first cannabis-based prescription drug within a few months.
The trials show good results for the oral spray, which is indicated for the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimised chronic opioid therapy.
According to GW, the regulatory submission filed in the UK and Spain has met no obstacles and both countries regulators have concluded that there are no major quality, safety or efficacy issues remaining to be resolved.
Resolution is now required only in points of clarification related to the finalisation of wording on the patient information leaflet, which when completed should allow for full authorisation within three months.
GW R&D director Stephen Wright said that this is a major milestone in the regulatory process for Sativex.
“This progress with Sativex also provides further validation of GW’s cannabinoid platform and the significant long-term promise of GW’s portfolio of cannabinoid medicines,” Wright said.
Following UK regulatory approval, GW expects to receive a £10m milestone payment from Bayer. A further £2.5m payment is payable by Almirall following both regulatory and pricing approval in Spain.