Does GW intend to try to develop Sativex® as a prescription medication in the US?
Has GW begun a US clinical trial?
What medical condition is being studied in this trial?
Where are the study locations?
Who can participate in the study?
Must patients stop taking their pain medications in order to participate in the study?
With which pharmaceutical company is GW working  in the United States?
Can patients obtain Sativex® through a compassionate use or Treatment IND program?

Does GW intend to try to develop Sativex® as a prescription medication in the US?
Yes. The US development program is now underway with a view to securing future regulatory approval for Sativex from the Food & Drug Administration (FDA). This program is being undertaken in collaboration with our US partner, Otsuka Pharmaceutical Co. Ltd. Sativex is being developed in the US as a treatment for patients with advanced cancer whose pain has not been adequately relieved by optimized treatment with strong opioid medications. The FDA has granted permission for Sativex to enter into pivotal Phase III trials. GW and Otsuka have elected for the first US study to be a Phase IIb/III dose-ranging study. Sativex® will be available on prescription in the US only when it has satisfied the FDA’s standards for quality, safety, and efficacy.
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Has GW begun a US clinical trial?
Yes. GW began to recruit patients into a Phase IIb/IIIclinical trial at the end of 2007.
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What medical condition is being studied in this trial?
The Phase IIb/III trial is researching Sativex in the treatment of patients with advanced cancer whose pain has not been adequately relieved by optimized treatment with strong opioid medications. Information about the SPRAY study (Sativex Pain Research in Advanced MalignancY) is available at www.SprayTrial.com.
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Where are the study locations?
The study is being conducted at approximately 33 research sites in the United States. in addition, there are study locations in a number of other countries in Europe and elsewhere. For further information about the research locations, see www.spraytrial.com.
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Who can participate in the study?
Patients with advanced cancer, whose pain is not adequately relieved by strong opioid medications, can be considered for participation in the study. For more information, see www.SprayTrial.com.
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Must patients stop taking their existing pain medications in order to participate in the study?
No. Patients continue to take their existing pain medications during their participation in the study.
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With which pharmaceutical company is GW working in the United States?
In February 2007, GW and Otsuka Pharmaceutical Co. Ltd signed an exclusive license agreement to develop and market Sativex® in the US. Under this agreement, GW and Otsuka jointly oversee US clinical development and regulatory activities as well as the commercialization strategy. GW is responsible for carrying out the US clinical development program, the costs of which are borne by Otsuka.  Otsuka will be responsible for the marketing and sales activities in the US.
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Can patients obtain Sativex® through a compassionate use or Treatment IND program?
GW intends to seek marketing approval for Sativex® by means of the conventional FDA regulatory process. As GW moves through that process, we will naturally follow the FDA's guidance, including what response the company should give to any requests for individual patient access through such compassionate use procedures. Until GW‘s clinical studies in the US have significantly progressed, we will not be a position to consider such requests.
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