Nasalfent shows clinically meaningful pain relief within 5 minutes of dosing and is well-tolerated
READING, England, 7 June 2007 - Archimedes Pharma Ltd ("Archimedes"), a European specialty pharmaceutical company, today presented new clinical data from a Phase II study of Nasalfent(r), an innovative fentanyl citrate nasal spray aimed at providing a fast, effective and convenient treatment for breakthrough cancer pain. Data were presented at the 10th Congress of the European Association for Palliative Care (EAPC) in Budapest showing that Nasalfent can give significant, clinically meaningful levels of pain relief and a reduction in pain intensity within 5 minutes of dosing.
The open-label, multi-centre study, was conducted in two parts - the first to establish an effective dose for each patient, followed by an efficacy phase in which the dose identified in part one was evaluated using a series of measures for pain relief. Statistically significant improvements from baseline in pain intensity and onset of pain relief were seen within five minutes of dosing (both p<0.05) in the 15 patients included in the efficacy analysis. All patients experienced at least one episode with meaningful pain relief and in the 55 breakthrough cancer pain episodes assessed, some degree of pain relief was recorded in 96% and clinically meaningful pain relief in 73%.
All doses of Nasalfent from 25mcg to 800mcg were well-tolerated, with no significant nasal findings or symptoms of irritation seen at any dose. In a patient satisfaction survey, 77% rated the product as 'good', 'very good' or 'excellent'.
Principal Investigator Dr Geoff Davis, Medical Director of Palliative Care, St Joseph's Care Group, Thunder Bay, Ontario, Canada said: "Breakthrough cancer pain is a significant clinical problem which requires a drug with a fast and reliable onset of action, together with ease of use and high patient acceptabilit y. This study provides the first clinical evidence for Nasalfent as an effective, acceptable and well-tolerated treatment and is also the first study to report clinically meaningful relief of breakthrough cancer pain at five minutes using a non-injected route of administration. A nasally-delivered product that offers more rapid onset of pain relief than that seen with existing oral therapies would help reduce the burden of breakthrough cancer pain for patients and their caregivers."
Dr Mark Watling, Medical Director of Archimedes said: "The data presented at today's EAPC congress highlights the potential of Nasalfent to address a significant market and medical need. With an international Phase III trial programme now underway, Archimedes is generating an extensive body of data to support regulatory filings in both the US and Europe with the aim of bringing a vital therapy to patients with breakthrough cancer pain."
Nasalfent is a trade mark of Archimedes and are registered as CTM, and US Registered Trademarks and in certain other jurisdictions.
Enquiries Archimedes Pharma: Michael Clark, +44 118 931 5050, +44 7973 111683 Citigate Dewe Rogerson: Chris Gardner, +44 (0)207 638 9571 For more information on Archimedes, visit: www.archimedespharma.com
Notes to Editors
About Archimedes Pharma Archimedes is a European specialty pharmaceutical company with an established commercial organisation in the UK, Ireland, France and Germany and a portfolio of products marketed to specialist prescribers. Archimedes' products include Gliadel, a biodegradable wafer impregnated with an anti-cancer drug, carmustine, for high-grade glioma; Zomorph, an oral sustained release morphine product for cancer pain; Nozinan, a neuroleptic which possesses anti-emetic, antihistamine and anti-adrenaline activity and used to treat patients with cancer; and Pabrinex, a high potency formulation of vitamin s B and C used to treat the symptoms of malnutrition especially in patients with acute alcohol problems.
Archimedes' strategy is to grow its commercial presence organically and through the acquisition of pharmaceutical companies or marketed brands in Europe and through partnering or licensing of European rights to new specialist prescribed products. In parallel, Archimedes is developing a robust pipeline of innovative near term products to support its commercial organisation. Its lead product, Nasalfent(r), intranasal fentanyl for rapid relief of breakthrough cancer pain, is in phase III clinical development and is targeted for launch in 2009. To provide further impetus and sales growth for the company in the medium term, Archimedes has an established development organisation with proprietary enabling technologies for nasal drug delivery and a number of products in development.
Citigate Dewe Rogerson is registered in England NO 218404. Registered office is 15-17 Huntsworth Mews, London, NW1 6DD.