Cambridge UK medical technology company GW Pharmaceuticals has stepped up its product push in the United States.
GW has opened a Phase 3 Investigational New Drug (IND) application with the US Food and Drug Administration to conduct a pivotal efficacy and safety clinical programme to evaluate Sativex for the treatment of spasticity caused by Multiple Sclerosis.
It is also pushing Sativex to cancer-related markets in the States.
Sativex, based on cannabis under Home Office licence, is currently approved in 22 countries outside the US. as a treatment for MS spasticity.
The proposed US Phase 3 program will be conducted under the agreement with GW’s licensing partner for Sativex, Otsuka Pharmaceutical Co. Ltd.
Otsuka is responsible for wholly funding the MS Phase 3 clinical program, as is the case with the current Phase 3 cancer pain program.
As part of its MS spasticity IND application, GW requested feedback from the FDA on key features of the proposed single Phase 3 trial protocol. GW expects to work with the FDA over the coming months to incorporate FDA feedback and to finalise the protocol design, which may include a request for Special Protocol Assessment (SPA). GW expects the trial to start in 2014.
Cancer pain remains the initial target indication for Sativex in the US and it is intended that MS spasticity would represent a future second indication for the US market.
GW and Otsuka are currently undertaking a Phase 3 clinical trials program for Sativex in cancer pain and results from two pivotal Phase 3 trials are expected in 2014.
CEO Justin Gover said: “With results from our US Phase 3 program in cancer pain due next year, this new Phase 3 IND provides us with the opportunity to broaden the future US market potential for Sativex to include MS spasticity.
“As such, this new IND represents an important extension of GW’s and Otsuka’s ambitions for Sativex in the US. We now look forward to working with the FDA to gain agreement on the required program to enable a future filing of an NDA for the MS indication.”
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