GW Pharma Opens Phase 3 IND Application In U.S. For Sativex For MS Spasticity

GW Pharmaceuticals plc (GWPH,GWP.L) has opened a Phase 3 Investigational New Drug or IND application with the U.S. Food and Drug Administration or FDA to conduct a pivotal efficacy and safety program to evaluate Sativex for the treatment of spasticity due to Multiple Sclerosis or MS. Currently, Sativex is approved in 22 countries outside the U.S. as a treatment for MS spasticity.

The proposed U.S. Phase 3 program would be conducted under the deal with GW's licensing partner for Sativex, Otsuka Pharmaceutical Co. Ltd. As part of GW's agreement with Otsuka, Otsuka is responsible for wholly funding the MS Phase 3 program, as is the case with the current Phase 3 cancer pain program.

According to 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 finalize the protocol design, which may include a request for Special Protocol Assessment or SPA. GW expects the Phase 3 study to begin in 2014.

GW and Otsuka are currently undertaking a Phase 3 trials program for Sativex in cancer pain and results from two pivotal Phase 3 trials are expected in 2014. "With results from our U.S. Phase 3 program in cancer pain due next year, this new Phase 3 IND provides us with the opportunity to broaden the future U.S. 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 U.S.," stated Justin Gover, Chief Executive Officer of GW.

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