Archimedes Pharma Enrols First Patient in Phase III Programme for Nasalfent in Cancer Pain
Archimedes Pharma Ltd announced the commencement of its global Phase III programme for Nasalfent® in breakthrough cancer pain. Up to 180 patients are being recruited in a placebo controlled, randomised trial across 43 centres in the US and Canada. The endpoints will focus on assessments of pain intensity and pain relief at several time points up to 60 minutes post treatment and will provide data on the acceptability and safety of Nasalfent. The lead investigator is Russell K. Portenoy, MD, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center, New York. Patients who successfully complete the trial will be eligible to enrol in a longer term open safety study.
Nasalfent is an fentanyl citrate nasal spray aimed at providing a fast, effective and convenient treatment for breakthrough cancer pain - sudden, unpredictable episodes of intense pain that occur despite background pain medication and which can affect up to 95% of cancer patients. Patients suffering from breakthrough cancer pain may have very limited treatment options. Fentanyl is a highly effective opiate analgesic and is seen as the drug of choice for breakthrough cancer pain because of its rapid onset and short duration of action.
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