New data from a Phase III trial of Archimedes’ breakthrough cancer pain spray NasalFent strengthen earlier findings that the product is superior to morphine, the current standard of care.

The market for breakthrough cancer pain is huge, with 95% of all cancer patients affected by the condition, which is characterised by sudden bouts of intense pain despite ‘background’ pain medication.

Breakthrough cancer pain is usually treated with immediate release morphine sulphate (IRMS), but there is growing excitement over the potential of NasalFent, an aqueous fentanyl citrate nasal spray built with Archimedes’ proprietary PecSys technology, which is attracting attention because of its powerful and fast action.

The PecSys technology behind the product improves on standard nasal sprays as it generates the formation of a thin layer of gel in the nostril that modulates drug absorption so that pain relief is delivered in a rapid but controlled manner, thereby increasing its duration of action, the firm said. Furthermore, it claims that it also helps to avoid common problems such as the dripping/swallowing of the drug or sub-therapeutic levels often seen with conventional nasal sprays.

Clinical trials to date have already demonstrated NasalFent’s ability to treat breakthrough cancer pain, but this latest set of Phase III data have confirmed that it has a faster effect than morphine, with a significantly greater number of pain episodes treated with the spray showing onset of effect within 5 minutes and clinically meaningful pain relief within 10 minutes.

In addition, patients treated with NasalFent experienced a statistically significant reduction in pain from baseline, as assessed by Pain Intensity Difference, from 10 minutes and at all time points up to and including 60 minutes, the group said.

Patient satisfaction
Furthermore, findings from the trial show that patients preferred NasalFent to IRMS, with the spray beating the standard of care on scores for speed of relief, reliability and overall satisfaction at both 30 minutes and 60 minutes after dosing.

According to Professor Marie Fallon, St Columba's Hospice Chair of Palliative Medicine, University of Edinburgh, the results are “hugely exciting”, particularly as “this is the first time a simple-to-use fentanyl product has been shown to be superior to the standard treatment for breakthrough cancer pain”, and she claims that “NasalFent offers the prospect of greatly improving the management of this distressing and common complication of cancer”.

Archimedes says NasalFent, which has been filed in Europe and is due to be filed in the US in the third quarter of this year, has a potential best-in-class profile among fentanyl products for breakthrough cancer pain, and the group is working towards a launch from the middle of next year.