Archimedes Pharma announces ground breaking phase III data for NasalFent

First study of a next generation fentanyl based product to show superiority over immediate release morphine

11-May-2009 - United Kingdom

Archimedes Pharma Limited announced new positive headline phase III results for NasalFent®, the Company’s highly differentiated fentanyl citrate nasal spray, developed for the rapid relief of breakthrough cancer pain. The ground breaking phase III study compared NasalFent to immediate release morphine sulphate, the most commonly prescribed medicine for breakthrough cancer pain.

NasalFent met the primary efficacy endpoint in the phase III study 044. Patients treated with NasalFent showed a statistically significant improvement in Pain Intensity Difference within 15 minutes (PID15) compared to immediate release morphine sulphate (p < 0.04), meaning a greater reduction in pain.

According to the company, NasalFent is the only one of the new generation of fentanyl products to have demonstrated statistically significant improvements over immediate release morphine sulphate. Significantly better improvements in pain scores for NasalFent versus immediate release morphine sulphate were seen at all subsequent time points indicating that superiority of NasalFent was maintained for 60 minutes after dosing.

NasalFent showed both consistent effectiveness and high acceptability; 94% of patients completed the double-blind part of the study and 70% of patients elected to continue therapy with NasalFent in the long term Phase III safety study.

Professor Marie Fallon, St Columba's Hospice Chair of Palliative Medicine, University of Edinburgh, Edinburgh Cancer Research Centre (CRUK) Western General Hospital Edinburgh, UK stated: “These data are hugely exciting. 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. NasalFent offers the prospect of greatly improving the management of this distressing and common complication of cancer”.

Study 044 was conducted in all major western European countries and in India, involving 35 expert investigational sites. A total of 135 patients were screened and 110 (82%) entered the open dose titration phase. 84 (76%) patients participated in the double-blind, placebo-controlled portion of the study. It is planned that data from study 044 will be presented at scientific meetings later in 2009.

https://www.bionity.com/en/news/100652/archimedes-pharma-announces-ground-breaking-phase-iii-data-for-nasalfent.html