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Ethan Russo, MD, GW Pharmaceuticals, 2235 Wylie Avenue, Missoula, MT 59802, 406-542-0151, erusso@montanadsl.net
Cannabis has been employed in human medicine for more than 4000 years, but has suffered political prohibition as well as rejection by the medical community due to issues of pulmonary sequelae of smoking including potential risks of carcinogenesis. Modern techniques employed by GW Pharmaceuticals have led to the development of standardized Cannabis Based Medicine Extracts (CBME) delivered by oromucosal spray that circumvent these problems and also meet all modern requirements of prescription products for safety, efficacy, and reliability. Regulatory approval of a lead product, Sativex®, is expected in the UK in late 2004 and Canada in 2005.
Whereas oral THC (Marinol®) has realized limited clinical application or acceptance, CBMEs are botanical products combining THC with cannabidiol (CBD), other synergistic cannabinoids and terpenoids that offer potentiation and summation of clinical benefits with mitigation of adverse effects in a pharmacokinetic vehicle that allows symptomatic control without undesirable cognitive impairment, or “high.” In this manner, CBMEs have demonstrated clinical efficacy in Phase II and III clinical trials of intractable pain and spasticity in multiple sclerosis, neuropathic pain, sleep disturbances, and intractable lower urinary tract symptoms (nocturia, frequency and incontinence). An optional Advanced Dispensing System (ADS) designed to monitor usage patterns, and prevent diversion of controlled substance will also be presented.
Learning Objectives: Learning objectives for this session will be
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: GW Pharmaceuticals
I have a significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.
Relationship: I am employed as GW Pharmaceutical's US Medical Director.