Akela reports positive results for Fentanyl Taifun trial

Akela says the results demonstrated statistically significant differences compared to placebo in the measured primary and secondary efficacy variables, resulting in faster and superior pain relief. Fentanyl Taifun is a fast-acting Fentanyl formulation delivered using the company’s Taifun dry powder inhaler platform.

A total of 50 patients were randomized and started the extension part of the study. In the intent-to-treat population, the median time to significant pain relief in the Fentanyl Tainfun group as measured by a decrease of at least 2 points on the numerical pain scale was 5.2 minutes, which was statistically significantly faster when compared to placebo.

The mean difference in sum of pain intensity difference was also statistically significantly in favor of Fentanyl Taifun for the whole 60 minute pain episode. This was already seen in numerical pain scale scores up to 15 minutes when compared to placebo.

“The additional knowledge and data accumulated during this clinical trial, as well as the positive feed-back by the authorities during the recent end-of-Phase II meetings makes us confident when preparing our Phase III study protocols,” said Dr Halvor Jaeger, CEO of Akela Pharma.