Archimedes Pharma announces ground breaking phase III data showing NasalFent to be superior to the standard of care for breakthrough cancer pain

Update: Lazanda (fentanyl nasal spray) Now FDA Approved - June 30, 2011

• Meets primary efficacy endpoint • First study of a next generation fentanyl based product to show superiority over immediate release morphine

READING, 8th May 2009 – Archimedes Pharma Limited, the UK based, pan-European specialty pharmaceutical company, today announces new positive headline phase III results for NasalFent®, the Company’s innovative and 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.

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 a duration of 30-60 minutes.

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.

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.

Richard de Souza, CEO of Archimedes, commented, "We are delighted with these results from another innovative study of NasalFent in what is the largest and most comprehensive clinical programme for any breakthrough cancer pain product. These data clearly show that NasalFent is superior to the benchmark product for this condition and fully supports the results from study 043 which demonstrate that NasalFent offers pain relief within 5 minutes of dosing and is highly acceptable to patients. Data from our third phase III study, 045, a long-term safety study, including over 500 patients, will be available shortly.”

Phase III data on NasalFent confirming best-in-class profile to be presented at major scientific congresses

Data from the phase III study 043 on NasalFent are to be presented at the American Pain Society (APS) on 7 and 8 May by Professor Allen Burton, Professor and Chair at the University of Texas and MD Anderson Cancer Centre in Houston, Texas, and at the European Association of Palliative Care (EAPC) on 9 and 10 May by Dr Russell Portenoy, Chairman, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York and Dr Donald Taylor, Medical Director and Anesthesiologist, Georgia Center for Cancer Pain Management & Palliative Medicine, Georgia.

Results covering both primary and secondary outcomes show statistical superiority for NasalFent over placebo and provide robust evidence for NasalFent as the first product to have demonstrated both rapid onset of pain relief within five minutes of dosing, and early clinically meaningful pain relief within 10 minutes of dosing. Use of rescue medication was low confirming that NasalFent was also consistently effective. Additional data presented showed that NasalFent produced highly significant improvements across a range of pain assessments. Nasal tolerability was excellent and side effects were generally mild to moderate in intensity and importantly were typical of fentanyl use in this patient population.

Professor Allen Burton, Professor and Chair at the University of Texas and MD Anderson Cancer Centre in Houston, Texas, who participated in the study and is presenting the data at the APS, said: “Breakthrough cancer pain is a significant clinical issue and these data illustrate the potential for NasalFent to offer ultra-rapid, consistent pain relief to the many patients who suffer from this unpredictable and extremely debilitating pain.”

 

American Pain Society 043 abstracts 1. Wallace M, Taylor D, Rauck R, et al. Fentanyl pectin nasal spray (FPNS) with PecSys®: efficacy, tolerability, and onset of action in the treatment of breakthrough cancer pain (BTCP). Poster #245 presented at: the American Pain Society 28th annual scientific meeting; May 7-9, 2009; San Diego,CA.

2. Burton A, Wallace M, Weinstein S, et al. Fentanyl pectin nasal spray (FPNS) with PecSys®: onset of action, consistency, and acceptability in breakthrough cancer pain (BTCP). Poster #244 presented at: the American Pain Society 28th annual scientific meeting; May 7-9, 2009; San Diego, CA.

- ENDS -

For further information, please contact:

Archimedes Pharma: Michael Clark, +44 118 931 5050 Capital MS&L (for corporate enquiries: Mary Clark, Joanna Whineray, +44 20 7307 5330 (for medical enquiries): Clare Lucker, +44 20 7878 3155 Trout International LLC (for investor enquiries): Mike Booth, +44 20 7936 9326

Note to Editors

About Archimedes Pharma Archimedes Pharma (“Archimedes”) is a pan-European specialty pharmaceutical company marketing and selling an expanding portfolio of specialist products to hospital-based prescribers in major European territories.

Focused on the oncology, pain, neurology and critical care sectors, Archimedes currently markets a range of products in the UK, France, Germany, Ireland and Belgium, and will continue to expand its commercial presence through partnering and acquisition activities during 2009. Products currently marketed in Europe by Archimedes include: Gliadel, a biodegradable wafer impregnated with carmustine, for high-grade glioma; Zomorph, an oral sustained release morphine product for pain; Oramorph, a liquid immediate release morphine product also for pain; Zibor, a second generation Low Molecular Weight Heparin for thromboprophylaxis; and Pabrinex, a high potency vitamin formulation used to treat the symptoms of malnutrition especially in patients with alcohol misuse problems.

Archimedes is also developing a robust, high value pipeline of in-house products in pain, Parkinson’s disease and critical care. It applies its world-class drug delivery technologies to proven molecules which have yet to achieve their market potential due to their current mode of delivery. This approach reduces the company’s development risk, while delivering significant clinical and commercial benefits.

NasalFent NasalFent is an innovative and highly differentiated aqueous fentanyl citrate nasal spray utilising Archimedes’ proprietary PecSys™ technology. NasalFent 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 similarly 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 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 as supratherapeutic levels of drugs and dripping or swallowing of drug solution. NasalFent is in development for rapid relief of breakthrough cancer pain.

Breakthrough cancer pain affects up to 95% of all cancer patients and is characterised by sudden, unpredictable episodes of intense pain typically lasting 30-60 minutes and which occur despite background opioid pain medication. 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.

Posted: May 2009

View comments

Hide
(web2)