Archimedes Announces European Filing Of NasalFent(R) For The Treatment Of Breakthrough Cancer Pain

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Pain / Anesthetics;  Ear, Nose and Throat
Article Date: 28 Apr 2009 - 3:00 PDT

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Archimedes Pharma ("Archimedes"), the pan-European specialty pharmaceutical company, today announced that it has submitted a centralised Marketing Authorisation Application with the European Medicines Evaluation Agency (EMEA) for approval of its lead development product, NasalFent, an innovative and highly differentiated fentanyl nasal spray for the rapid relief of breakthrough cancer pain.

The NasalFent clinical development programme was comprehensive and involved more than 100 investigational sites in 13 countries across four continents. Data from this programme showed that NasalFent met both its primary and secondary endpoints, and of particular importance was the finding that NasalFent showed a statistically significant difference in pain scores compared to placebo within five minutes of dosing. Patients and physicians rated NasalFent highly in terms of convenience, acceptability and speed of onset of pain relief. In addition, the requirement for rescue medication was low, in less than six per cent of episodes, confirming that NasalFent is consistently effective for this indication.

Richard de Souza, Chief Executive Officer of Archimedes, commented: "This filing is a major milestone for Archimedes and a significant step forward in the development of NasalFent, our lead product. In developing NasalFent, we have carried out one of the most comprehensive phase III clinical programmes in breakthrough cancer pain and these studies have shown that NasalFent provides statistically significant and clinically meaningful results. NasalFent represents the optimal therapeutic profile against a breakthrough cancer pain episode as defined by patient needs and, furthermore, demonstrates clear advantages over existing competitor treatments either on the market or in development."

NasalFent

The Group's lead development product is NasalFent, an innovative and highly differentiated fentanyl citrate nasal spray, for the rapid relief of breakthrough cancer pain, based on Archimedes' PecSys™ technology. Initial Phase III data illustrates that NasalFent has a potential best-in-class profile among fentanyl products for breakthrough cancer pain and is the first product to demonstrate onset of pain relief within five minutes of dosing. NasalFent will be filed for regulatory approvals from Q2 2009 and is targeted for launch from mid-2010.

NasalFent is an aqueous fentanyl citrate solution utilising Archimedes' proprietary PecSys™ technology. The NasalFent solution has a low viscosity and is easily delivered in a low volume of 100mcl using a conventional nasal spray pump. The pump produces a fine mist of equally sized spray droplets which are deposited into the front of the nostril. The calcium ions present in nasal mucosal fluid cause the pectin to form a thin gel layer resulting in modulated drug absorption, allowing rapid absorption but controlled absorption into the systemic circulation and an increased duration of action. PecSys™ technology avoids problems associated with simple solutions used as nasal sprays such supratherapeutic levels of drugs and dripping or swallowing of drug solution.

Source
Archimedes Pharma