GW reveals strong Sativex data in multiple sclerosis

The UK's GW Pharmaceuticals says that results from two clinical studies of Sativex, the firm's lead cannabinoid product, were presented at Europe's leading multiple sclerosis (MS) conference, the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which took place in Dusseldorf, Germany, from 9-12 September. The outcome of these MS spasticity studies were first reported by GW earlier this year.

Approved by Health Canada under a license with conditions for prescription use in April 2005, Sativex is the world's first prescription medicine derived from the cannabis plant. The product is approved in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis and, more recently, for pain due to cancer. It is also available in a number of countries as an unlicensed medicine, which enables doctors to prescribe the product to individual patients who they consider may benefit.

Presentation of data from the Phase III MS spasticity trial was shortlisted by the conference for a prize. In this trial, 572 patients were enrolled into Phase A and 241 continued into Phase B. The authors conclude that 'Sativex demonstrated a statistically-significant and clinically-relevant improvement in spasticity and was well tolerated in MS patients'. The primary endpoint was significantly in favor of Sativex (p=0.0002). In addition, the 30% responder analysis, spasm frequency, sleep disruption, Physician, Carer and Subject Global Impression of Change and Barthel Activities of Daily Living index were all significantly in favour of Sativex (p=0.0003, p=0.0046, p

<0.0001, p="0.0045," p="0.0053," p="0.0234" and p="0.0067" respectively).>

A separate presentation from this trial specifically assessed the value of a four-week trial of treatment of MS spasticity with Sativex. The authors conclude that 'a four-week trial period with Sativex can effectively detect MS spasticity patients who will demonstrate positive outcomes in longer-term treatment'.