Archimedes publishes results from FPNS Phase III clinical study for breakthrough cancer pain

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."