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: 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 Pharma

Archimedes 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.

SOURCE Archimedes Pharma