GW Pharmaceuticals announces positive preliminary results in a Phase III clinical trial with Sativex® in 125 patients with neuropathic (nerve damage) pain.
In the Phase III trial, a statistically significant improvement in comparison to placebo was achieved in pain as measured on a numerical rating scale (p[0.01), the primary endpoint of the study. In addition, positive results were obtained in the majority of secondary outcome measures including allodynia (p[0.05), pain disability index (p[0.01), quality of sleep (p[0.01), and patients’ global impression of change (p[0.01).
The trial was a multi centre double-blind, randomised, placebo-controlled parallel group study of Sativex in the treatment of peripheral neuropathic pain characterised by allodynia. In addition to study medication, all patients remained on their existing medication during the course of the trial.
Allodynia is the occurrence of pain in response to a normally non-painful stimulus (e.g. clothes touching against the skin). It is often intense and can occur in patients suffering from a range of conditions that damage the peripheral nerves (e.g. diabetes, post-herpetic neuralgia) and is a highly reliable marker of neuropathic pain.
In the trial, the safety profile was consistent to that shown in previous Sativex studies with adverse events being generally mild or moderate in intensity.
Dr Geoffrey Guy, Executive Chairman, said, “Neuropathic pain is one of the most difficult types of chronic pain to treat and available treatment options are limited. This Phase III trial adds further strong support to the body of evidence in neuropathic pain generated from GW’s earlier clinical trials. As in previous trials, the results obtained are over and above the effects of the patients’ existing drug treatments. We therefore believe that Sativex may present an important therapeutic advance for patients suffering from this condition.”
Sativex is currently the subject of regulatory applications in both the UK and Canada. In both countries, upon approval, Sativex will be exclusively marketed by Bayer HealthCare.
GW Pharmaceuticals plc
Dr Geoffrey Guy, Chairman
Justin Gover, Managing Director
Mark Rogerson, Press and PR
Weber Shandwick Square Mile
020 7067 0700
Kevin Smith / Sarah MacLeod
(Vgl. Meldung vom 2004-06-15.)
Source: GW Pharm Press Release vom 2004-06-15.