Wafernyl™ - for breakthrough cancer pain

Wafernyl™ is a wafer containing fentanyl for management of breakthrough cancer pain using the rapidly dispersible WaferiX™ which is to be placed under the tongue. It has been reported that treatment of transient breakthrough pain requires a fast acting medication that provides immediate pain relief before the "natural" disappearance of the pain. The sublingual absorption of fentanyl provides for prompt achievement of therapeutic plasma concentrations comparable to intravenous administration of fentanyl but is devoid of the harmful high peak concentration. Wafernyl™ dissolves rapidly within a minute of administration with no residue when placed under the tongue.

Phase 1 Clinical Study

Study Design & Objective: This is an open label study to compare the pharmacokinetics and bioavailability of 100µg sublingual wafer fentanyl to the currently registered 100µg intravenous formulation of fentanyl.

Study Sample: 24 healthy adult male and female volunteers were enrolled for this study.

Results: Sublingual administration of Wafernyl™ resulted in rapidly detectable plasma fentanyl concentrations. The absolute bioavailability of 78.9% indicated a high systemic availability of fentanyl and suggests that further development of Wafernyl™ is justified. (A Phase 1 Pharmacokinetic and Bioavailability Study of a Sublingual Fentanyl Wafer in Healthy Volunteers, Anesthesia and Analgesia, September 2012).

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