Archimedes Pharma: First Positive Phase III Clinical Trial Results for NasalFent
Shows Significant Difference in Pain Within 5 Minutes of Dosing
Archimedes Pharma Limited, the UK based, pan-European specialty pharmaceutical company, announces positive headline Phase III results for NasalFent®, the Company’s innovative fentanyl citrate nasal spray, developed to provide fast, effective and convenient treatment for breakthrough cancer pain.
Breakthrough cancer pain affects up to 95% of all cancer patients and is characterised by sudden, unpredictable episodes of intense pain that occur despite background pain medication. This pain is rapid in onset, often reaching maximum intensity in 5 minutes with duration of 30-60 minutes.
NasalFent met the primary efficacy endpoint in study 043, a pivotal Phase III clinical study for the product. Patients treated with NasalFent showed a highly statistically significant improvement in Summary of Pain Intensity Difference at 30 minutes (SPID30) compared to placebo (p < 0.001), meaning a greater reduction in pain.
Patients also reported statistically significant differences in pain scores with NasalFent compared to placebo within 5 minutes of dosing. NasalFent is the first product to have demonstrated, in a robust large scale Phase III programme, onset of pain relief as early as 5 minutes. The improvement in pain was maintained for 60 minutes after dosing with statistically significant results at all measured time points.
NasalFent showed both consistent effectiveness and high acceptability; 92% of patients completed the double-blind part of the study and 87% of patients elected to continue therapy with NasalFent in a long term Phase III safety study.
Russell K. Portenoy, MD, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center, New York and Principal Investigator for the NasalFent study programme, stated: “Breakthrough cancer pain is a significant clinical problem and there is a clear need for new analgesic formulations that are safe and effective, and provide pain relief in a time frame consistent with the rapid time course of most breakthrough pain episodes.”
Study 043 was conducted in the Americas, principally the USA, and involved 36 expert investigational sites. A total of 139 patients were screened and 114 (82%) entered the open dose titration phase. Eighty three (83) patients participated in the double-blind, placebo-controlled portion of the study. The protocol for study 043 was agreed with the FDA and is very close in design to studies for approved fentanyl-based products for breakthrough cancer pain.
Richard de Souza, CEO of Archimedes, commented, "We are pleased with the study results which position NasalFent, the first real intranasal form of fentanyl, as a product that redefines the standard of care for patients suffering with breakthrough cancer pain. This achievement validates our business model which is to build a fast growing commercial organisation capable of marketing the pipeline of products built around our proprietary nasal technology and developed by our in-house team.”
NasalFent consists of fentanyl in an aqueous solution delivered as a low volume nasal spray. The formulation incorporates PecSys™, Archimedes’ proprietary enabling drug delivery technology. NasalFent is designed to optimise the absorption of Fentanyl across the nasal mucosa, allowing rapid absorption for fast onset of pain relief but modulating the maximum amount of fentanyl absorbed in order to minimize side effects.
Donald R.Taylor, MD, Director of the Comprehensive Pain Care Centre, Marietta, Georgia added, "NasalFent, a new analgesic for breakthrough cancer pain, clearly provides more rapid pain relief than traditional breakthrough cancer pain medications and is well accepted by patients. It is also uniquely useful for patients with swallowing difficulties due to their cancer or its treatment."
Archimedes intends to publish full results for 043, along with additional data on the pharmacokinetic and pharmacodynamic profile of NasalFent compared current therapies, at a series of scientific conferences in 2009.
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