Archimedes Pharma has published 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.
The randomised, 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 study met its primary endpoint in demonstrating a significant difference in summed pain intensity difference 30 minutes after dosing.
In addition, benefits in pain intensity were noted at five minutes after dosing and were maintained to the end of the assessment period and adverse events in the study were typical of an opioid medication in the population.
Archimedes Pharma president and CEO Jeff Buchalter said that BTCP, which remains under recognised and inadequately managed, affects up to 95% of all cancer patients and FPNS’ pectin-based transmucosal delivery system is characterised by reduced time to onset of effect, which helps overcome one limitation associated with treatment by conventional opioids.