BioWorld International Correspondent

LONDON - GW Pharmaceuticals plc announced positive results in a Phase III trial of Sativex, its cannabis-derived sublingual spray, and said it is in talks to file its first U.S. investigational new drug application for the product later this year.

The trial of Sativex in the treatment of severe cancer pain is the third indication in which the Salisbury, UK-based company has reported positive Phase III results, and the data file will grow further in the next few months as two more Phase III trials report.

The expansion of the trials database, plus new preclinical safety data and an evolving regulatory situation, means, "GW can now plot out a more expansive regulatory strategy," Stephen Wright, research and development director, told an analysts' meeting in London last week.

The company will aim to expand the indications in Canada where Sativex has received notice of approval in neuropathic pain caused by multiple sclerosis, and will submit additional data in an appeal against the decision by UK regulators not to approve the product in the treatment of spasticity in multiple sclerosis.

"Most importantly, we can now look much more confidently to get an IND in the U.S. because of the new preclinical safety data," Wright said. GW will decide which indication to work on in the U.S. following discussions with the FDA, and hopes it will be able to start with Phase II trials.

The Phase III trial of Sativex in severe cancer pain studied 177 patients in advanced stages of disease receiving palliative care in hospices. "It is important to emphasize the severity of patient need," Wright said. "They were receiving maintenance analgesics, but despite that all had at least moderate to severe pain still."

About 40 percent of patients on Sativex showed a greater than 30 percent reduction in pain levels.

GW said patient recruitment is complete in Phase III trials in spinal cord injury and bladder dysfunction in multiple sclerosis and those will report in the first half of the year. Sativex has been used by 1,000 subjects to date and there now is 1,000 patient years of safety data.

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