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What is GW doing to try to develop Sativex® as a prescsription medication in the US?

Smokin Moose

Fallen Cannabis Warrior
Taken from GW Pharmaceuticals.

As we extend our development program to other countries, GW continues to strive, in accordance with each nation’s regulatory system, to achieve our goal of making cannabinoid prescription medications available to patients with serious unmet medical needs. In January 2006, the FDA informed GW that our Investigative New Drug application (IND) had been accepted and that we could proceed directly into pivotal Phase III clinical trials, the last stage of clinical research that must be completed before a company may submit a marketing application. In April 2007, after taking advice from experts in clinical trial design, GW concluded that the US development program would be strengthened if a Phase II dose-ranging study were to be undertaken in advance of the Phase III 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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GW intends to start its first clinical trial in the US towards the end of 2007.


What medical condition will be studied in these trials?
The trials will involve patients with advanced cancer whose pain has not been adequately relieved by optimized treatment with strong opioid medications.
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Which pharmaceutical company is GW working with 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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What impact would the approval of Sativex® in the US have on the availability, for medical purposes, of crude herbal cannabis?
Future approval of Sativex® in the US would not mean that any other presentation of cannabis would be made available as a prescription medicine in the US or elsewhere, unless and until that specific presentation or product has gone through the same rigorous research, testing, and regulatory approval processes.
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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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Must herbal cannabis be rescheduled (out of Schedule 1 of the US Controlled Substances Act) in order for Sativex® to be approved as a prescription medicine in the US?
No, Sativex® will be available on prescription in the US only when it has satisfied the FDA’s standards for quality, safety, and efficacy and meets the relevant Drug Enforcement Administration registration requirements for such an approved product. Cannabis’s placement in Schedule 1 has no effect on the fact that Sativex® must satisfy the FDA’s regulatory requirements. Rescheduling cannabis would not reduce the stringency of such requirements; conversely, approval of Sativex® will have no effect on the scheduling of crude herbal cannabis, which would remain in Schedule 1. GW will naturally keep patients and physicians apprised as we achieve various milestones in the FDA regulatory process.
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Why has GW devoted so much time and effort to make a cannabinoid pharmaceutical product?
Sativex® is a cannabinoid pharmaceutical product standardized in composition, formulation, and dose, administered by means of an appropriate delivery system, which has been, and continues to be, tested in properly controlled preclinical and clinical studies. Crude herbal cannabis in any form--including a crude extract or tincture-- is none of those things. We believe that most patients and most physicians should accept only a product that meets the standards of modern medicine. Since the company’s founding in 1998, GW has consistently maintained a single objective: to develop modern medicines that satisfy international standards for quality, safety, and efficacy, while also meeting the medical needs of seriously and chronically ill patients. Moreover, GW has conducted its program exclusively in accordance with the parameters of modern medical and pharmaceutical practice.

GW is entirely focused on creating cannabinoid medications that can be made available on prescription to patients 1) whose conditions have been shown to benefit from such medicines and 2) who wish to obtain their medical treatment from their physicians in accordance with the standards of modern medical practice.
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Has GW been involved in the US debate about “medical marijuana”?
GW is aware that there is a broader debate in the US and elsewhere relating to the use of crude herbal cannabis (often called marijuana) for medical and/or non-medical purposes. This sometimes-fierce discourse is overlain with political issues and has largely taken place outside the field of science. Since we are a pharmaceutical company, GW has quite appropriately taken no part in that political controversy. We have simply tried to proceed with the important work of developing the scientific data necessary to enable us to improve the plight of patients with serious unmet needs.
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What is GW's position on crude herbal cannabis?
GW has never endorsed or supported the idea of distributing or legalizing crude herbal cannabis for medical use. In both our publications and presentations, we have consistently maintained that only a cannabinoid medication--one that is standardized in composition, formulation, and dose, administered by means of an appropriate delivery system, and tested in properly controlled preclinical and clinical studies--can meet the standards of regulatory authorities around the world, including those of the FDA. These criteria are also mandatory if the modern medical model—informed patients working with, and being advised by, knowledgeable physicians to identify appropriate treatment options--is ever to be attained with a cannabinoid medication.

We have also repeatedly stressed that these regulatory processes provide important protections for patients, and we believe that any cannabinoid medication must be subjected to, and satisfy, such rigorous scrutiny.
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Certain cannabis advocacy groups have claimed that Sativex® is just “liquid marijuana”. Why does GW disagree with this view?
Sativex® is not "liquid marijuana." Sativex® is a pharmaceutical product standardized in composition, formulation, and dose, administered by means of an appropriate delivery system, which has been, and continues to be, tested in properly controlled preclinical and clinical studies. Crude herbal cannabis in any form--including a crude extract or tincture-- is none of those things. Such tinctures and extracts are unstandardized in quality, content, and dose and therefore are uncertain in effect.
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© GW Pharmaceuticals 2007
 
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