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

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:

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: contacts:Tiberend Strategic Advisors, Inc. (USA)Tamara Bright +1 212-827-0020 Citigate Dewe Rogerson (UK and Europe)Chris Gardner +44 207 638 9571

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:
(Date:11/25/2015)... , Nov. 25, 2015  Trovagene, Inc. (NASDAQ: ... today announced that Chief Executive Officer Antonius Schuh, Ph.D., ... 27 th Annual Piper Jaffray Healthcare Conference. ... the New York Palace Hotel in New ... 1:30 p.m. EST. Mr. Schuh will be available for ...
(Date:11/25/2015)... International plc (NASDAQ: ENDP ) (TSX: ENL) today announced ... discuss corporate updates at the 27 th Annual Piper ... on Wednesday, December 2, 2015 at 1 p.m. ET. ... the link to the event. Participants should allow approximately 10 ... site and download any streaming media software needed to listen ...
(Date:11/25/2015)... AVIV, Israel , November 25, 2015 ... (the "New Investors"), pursuant to which BioLight and the ... BioLight,s IOPtima Ltd. subsidiary ("IOPtima") via a private placement. ... commercialization of its innovative IOPtimate™ system used in the ... regulatory approval pathway process for the IOPtimate™ system with ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... ... aggressive than those found on mammography, according to a study published online in ... cancers not seen on mammography may necessitate a change in treatment. , Breast ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... preparing the perfect dish and pleasing the palates of attendees is of the ... a dish to a seasonal get-together, give these recipes a try this holiday ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... been recognized once again for its stellar workplace culture with the company’s Cincinnati ... , Medical Solutions’ Cincinnati office was named a finalist in Cincinnati Business ...
(Date:11/25/2015)... NV (PRWEB) , ... November 25, 2015 , ... Dr. ... patients to learn more about hair loss treatment with the Capillus272™ Pro laser therapy ... effective solution for thicker and fuller hair, without the need for surgery, prescription pills, ...
(Date:11/25/2015)... ... November 25, 2015 , ... On November 10, 2015, Bohrer ... Court of Connecticut on behalf of a home health care worker who provided companionship ... former home health care workers employed by Humana, Inc., Humana at Home, Inc., and ...
Breaking Medicine News(10 mins):