Navigation Links
Archimedes Pharma Presents Positive Efficacy and Safety Data on,Nasalfent at European Association for Palliative Care Congress

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.


'"/>




Related medicine technology :

1. Sygnis Pharma AG announces date for presentation of clinical results
2. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
3. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
5. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
6. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
7. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
8. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
9. Array BioPharma to Present at the C.E Unterbeg, Towbin Emerging Growth Conference
10. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
11. TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , April 28, 2016   Click here ... Pharmacy, Inc. (NYSE: DPLO), the nation,s largest independent ... a definitive agreement to acquire Valley Campus Pharmacy, ... ("TNH"), a leading specialty pharmacy that provides individualized ... California . In 2015, TNH generated approximately ...
(Date:4/28/2016)... BURLINGAME, Calif. , April 28, 2016 /PRNewswire/ ... first-ever widely accessible breast and ovarian cancer risk ... cancer panel analyzing 30 genes that highly impact ... and women. Available today, the Color Test analyzes ... pancreatic, prostate, stomach, and uterine cancers. The Color ...
(Date:4/28/2016)... April 28, 2016 Treato ... on healthcare, announced today that it has been named ... Cool Vendor in Life Sciences, 2016, Stephen ...  The report focuses on life-science- oriented analytics, algorithms and ... patients and doctors, confirm medication ingestion, and analyze unstructured ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 29, 2016 , ... On Tuesday, April 26, 2016 members of the ... signature of Gov. Nathan Deal on SB 258, the “Rural Health Care Relief” Bill. ... a 70% tax credit to individuals and corporations which donate directly to a “rural ...
(Date:4/29/2016)... ... 29, 2016 , ... Conditions were ideal for Global Lyme Alliance’s (GLA) 2nd ... sunny skies, a light breeze and temperatures in the 60s. Over 400 runners, walkers ... and Walk and 1-mile walk were held to increase awareness about Lyme disease ...
(Date:4/29/2016)... PA (PRWEB) , ... April 29, 2016 , ... ... announced that student team BioCellection won the $30,000 Perlman Grand Prize of the ... Prize, the Gloeckner Undergraduate Award, the Michelson People’s Choice Award, and the Committee ...
(Date:4/29/2016)... ... 29, 2016 , ... Melanoma is the deadliest type of skin cancer. Although only about 1 ... skin cancer deaths. More than 10,000 people are expected to die of melanoma this year. ... is the one of the most commonly diagnosed cancers in young women. A recent breakthrough ...
(Date:4/29/2016)... , ... April 29, 2016 , ... For those who ... the meal to miss. That was among the many new lifestyle diet tips offered ... recent Sharon Kleyne Hour® Power of Water® radio show. Bonny and Lawrence noted that ...
Breaking Medicine News(10 mins):