Navigation Links
Archimedes Pharma Announces Publication of Long-Term Safety and Tolerability Clinical Study of Fentanyl Pectin Nasal Spray (FPNS) in the Journal of Opioid Management
Date:10/12/2010

READING, England and BEDMINSTER, N.J., Oct. 12 /PRNewswire/ -- Archimedes Pharma, an emerging specialty pharma company focused on oncology, pain, neurology and critical care sectors, today announced publication of results from a Phase III, long-term safety, tolerability and consistency of effect, clinical study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain (BTCP).

The article, entitled "Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients," [fentanyl pectin nasal spray is called PecFent® in Europe] has been published in the September/October issue of the Journal of Opioid Management.  The Phase III multicenter open-label study analyzed 403 adult cancer patients and was conducted in 91 centers over 16 weeks.  FPNS was self-administered for 42,227 episodes of BTCP.  The study assessed the long-term safety, tolerability, and consistency of FPNS effectiveness and dose in adult cancer patients with BTCP. The abstract of the study is available at: http://bit.ly/a8ptCF.

This study demonstrated that FPNS was acceptable and generally well tolerated in patients suffering from breakthrough cancer pain. In this trial the most frequently reported adverse events were typical of opioid medications and included dizziness, vomiting, constipation and somnolence. Nasal tolerability of FPNS over the long term was demonstrated as good with no significant nasal adverse events.  94% of BTCP episodes were successfully treated by a single dose of FPNS and did not require additional rescue medication within 60 minutes of FPNS treatment. In addition, more than 90% of patients required no increase in their dose of FPNS, once titration was achieved.

Jeff Buchalter, President and CEO of Archimedes Pharma, commented, "The long-term usage data continues to support FPNS as a highly acceptable and consistently effective product for the long-term treatment of BTCP."  He continued, "With our recent launch of PecFent® in the UK and upcoming launches in additional European countries, Archimedes Pharma is providing a new therapy to improve the treatment options for adult patients with breakthrough cancer pain.  An NDA has been submitted with the US Food and Drug Administration and is currently under review."

Notes to editors:About Archimedes PharmaArchimedes Pharma is an international specialty pharmaceutical company focused on the oncology, pain, neurology, and critical care sectors. Archimedes Pharma is marketing an expanding portfolio of specialist products to hospital-based prescribers in Europe and has established commercial organizations in the UK, US, France, Germany, Ireland, and Spain.

Fentanyl Pectin Nasal Spray [called PecFent® in Europe]

PecFent is an innovative fentanyl pectin citrate nasal spray that has been granted Marketing Authorization by the European Medicines Agency for the treatment of breakthrough cancer pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain.  It is under review by the US Food and Drug Administration (FDA).

In the clinical trial program, the use of PecFent in the treatment of breakthrough cancer pain was associated with the occurrence of adverse events typical of opioid medication in this population.  The most frequently reported were vomiting, nausea, disease progression and constipation.  The majority of such events were mild to moderate in intensity, and adverse effects assessed as treatment-related led to study withdrawal in 3.9% of patients.

About Breakthrough Cancer Pain (BTCP)

Breakthrough cancer pain affects 24% to 95% (average across all studies 62%) of all cancer patients with pain and is characterized by sudden, often unpredictable episodes of intense pain that occur despite background pain medication. This pain is rapid in onset, usually reaching maximum intensity in five minutes and lasting for 30 to 60 minutes.

For more information, please visit: www.archimedespharma.com.Media contacts:Tiberend Strategic Advisors, Inc. (USA)Tamara Bright +1 212-827-0020 tbright@tiberendstrategicadvisors.com Citigate Dewe Rogerson (UK and Europe)Chris Gardner +44 207 638 9571 chris.gardner@citigatedr.co.uk
'/>"/>

SOURCE Archimedes Pharma
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Archimedes Pharma Announces Publication of a Pivotal Clinical Study of Fentanyl Pectin Nasal Spray (FPNS) in Pain, the Peer-Reviewed Journal from the International Association for the Study of Pain
2. Archimedes Pharma Receives CHMP Positive Opinion for PecFent(R) for the Treatment of Breakthrough Cancer Pain
3. Archimedes Pharma Announces Successful Proof-of-Concept Results on Two Intranasal Development Projects
4. Auxilium Pharmaceuticals, Inc. Announces Issuance of Patent for Clostridial Collagenase
5. Cranewares Pharmacy ChargeLink® Version 3 Helps Improve Margins and Control Costs
6. Johnson & Johnson to Host Analyst Meeting to Discuss Third-Quarter Financial Results and Review Pharmaceutical Business
7. Generex Reaches Agreement to Acquire 51% Stake in Global Medical Direct, a Nationwide Durable Medical Equipment and Pharmaceutical Provider Specializing in Direct-to-Consumer Diabetes Supplies
8. Newly Revised Concepts in Clinical Pharmacokinetics Web-Based Continuing Education Course Offered by the University of Georgia
9. Webcast Alert: CEL-SCI Corp. (CVM) Announces the Biotech, Healthcare and Pharma Virtual Conference
10. PharmaNet Development Group Announces Observational Research Survey
11. Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/28/2017)... Sept. 28, 2017 Hill-Rom Holdings, Inc. (NYSE: ... conference call and webcast on Friday, November 3, 2017, ... and ending at approximately 8:30 a.m. (CDT) / 9:30 ... company,s 2017 financial performance and guidance for 2018, Hill-Rom ... to enhance operational performance, and long-range financial outlook through ...
(Date:9/25/2017)... Sept. 25, 2017  EpiVax, Inc., a leader ... and immune-engineering today announced the launch of EpiVax ... of personalized therapeutic cancer vaccines. EpiVax has provided ... access to enabling technologies to the new precision ... lead EpiVax Oncology as Chief Executive Officer. Gad ...
(Date:9/19/2017)... , Sept. 19, 2017   ZirMed Inc ., a ... today announced that it has been ranked #1 by its ... Book™ Rankings 2017 User Survey. ZirMed was recognized as ... large hospitals and medical centers over 200 beds and holds ... healthcare technology user survey history. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... While it’s often important to take certain medications during the night, finding ... identified a solution. , She developed a prototype for MOTION LIGHT-UP PILL BOX to ... the need to turn on a light when taking medication during the night, allowing ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health and Nutrition ... the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing CBD market ... can be easily incorporated into liquid products, while reducing costs to end users. , ...
(Date:10/13/2017)... Shelton, CT (PRWEB) , ... October 13, 2017 , ... ... and long-term care services, staged a mock evacuation of the facility as part of ... Department, Shelton Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well ...
(Date:10/13/2017)... ... ... Ellevate Network, the leading network for professional women, brought together some of ... their inaugural Summit in New York City in June. The event was livestreamed with ... 3 million. To watch the Mobilize Women video, click here . , ...
(Date:10/13/2017)... ... ... Talented host, actor Rob Lowe, is introducing a segment ... of "Success Files," which is an award-winning educational program broadcasted on PBS Member ... with passion and integrity. , Sciatica occurs when the sciatic nerve in the ...
Breaking Medicine News(10 mins):