GW Pharmaceuticals, the developer of cannabis-based medicinal products, has released a puff piece about a favourable review of its Sativex product in a US medical journal.
The "Journal of Pain", the official journal of the American Pain Society, has published the full results from a Phase IIb dose-ranging trial evaluating the efficacy and safety of Sativex in the treatment of pain in patients with advanced cancer, who experience inadequate pain relief (analgesia) during optimised chronic pain suppression therapy.
The Phase IIb study was the first major trial carried out by GW and its partner Otsuka Pharmaceutical as part of the development programme aimed at securing regulatory approval for Sativex from the US Food & Drug Administration (FDA).
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Top line results from this study were originally reported in March 2010 and a Phase III trials programme has since commenced.
The publication's lead author, Dr Russell Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City, said, "The finding in this dose ranging study that Sativex has potential analgesic efficacy as add-on therapy for pain due to advanced cancer that is poorly responsive to opioid therapy has great potential clinical relevance."
Phase III confirmatory studies are strongly warranted in Dr Portenoy's view, and, if positive, "may provide an opportunity to address a significant clinical challenge."
The Phase III trials programme is being funded by Japanese pharmaceuticals giant Otsuka.
Shares in GW Pharmaceuticals rose 2.125p to 92p in morning trade, after hitting 93.75p at one stage.
JH
