Fentanyl Pectin Nasal Spray Effective in Clinical Study

The results from a clinical study of Fentanyl Pectin Nasal Spray in the treatment of breakthrough cancer pain are in.

The results from a clinical study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain (BTCP) are in.

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,” was published in Pain, the peer-reviewed journal from the International Association for the Study of Pain.”

The Fentanyl Pectin Nasal Spray (FPNS) is manufactured by Archimedes Pharma US Inc. The 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 primary endpoint of the study was to demonstrate a significant difference in pain intensity difference 30 minutes after dosing. The study results demonstrate the endpoint was achieved. 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 similar to other opioid medication in the treatment of breakthrough pain. The most frequently common adverse events were vomiting, nausea, disease progression and constipation, but the majority of the 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, in a press release, “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."

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.

Archimedes Pharma's manufactures fentanyl nasal spray, PecFent, which is approved in Europe 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 FDA.

Breakthrough cancer pain affects up to 95% of all cancer patients with pain. It is characterized by sudden, 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.