Archimedes publishes FPNS clinical study results in Pain journal

Archimedes Pharma US Inc. today announced publication of results from a pivotal clinical study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain (BTCP). The article, entitled "A multicenter, placebo-controlled, double-blind, multiple-crossover study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain," has been published in Pain, the peer-reviewed journal from the International Association for the Study of Pain.  

This randomized, placebo-controlled, double-blind study assessed the efficacy and tolerability of FPNS in cancer patients with breakthrough pain in spite of receiving adequate background opioid therapy.  The full text of the study is available at http://www.jpain.org/.

This study met its primary endpoint in demonstrating a significant difference in summed pain intensity difference 30 minutes after dosing (SPID30; p<0.0001).  In addition, significant benefits in pain intensity were noted at five minutes after dosing and were maintained to the end of the assessment period.  Adverse events in the study were typical of an opioid medication in this population.  The most frequently reported adverse events were vomiting, nausea, disease progression and constipation; the majority of such events were mild to moderate in intensity.

The trial's lead investigator, Dr. Russell Portenoy, chairman of the Department of Pain Medicine at New York's Beth Israel Hospital, said, "Both the prevalence and negative impact of breakthrough cancer pain support the need for new treatments.  A rapid onset formulation has a clear rationale, potentially addressing the well documented mismatch between the time course of most breakthrough pains and the time action relationship of oral drugs."

Jeff Buchalter, President and CEO of Archimedes Pharma, commented, "BTCP, which remains under recognized and inadequately managed, affects up to 95% of all cancer patients.  FPNS' proprietary pectin-based transmucosal delivery system is characterized by reduced time to onset of effect, which helps overcome one limitation associated with treatment by conventional opioids."