AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFU...( http://w MONTREAL Sept....),Health

http://www.akelapharma.com Toronto Stock Exchange Symbol: AKL

MONTREAL, Sept. 5 /PRNewswire-FirstCall/ - AKELA Pharma Inc., (TSX: AKL), a drug development company focused on developing therapies for the inhalation, pain and CNS markets, today announced positive results from the double-blind extension part of its Fentanyl TAIFUN(R) Phase IIb trial. 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(R) is a fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry powder inhaler platform.

A total of 50 patients were randomized and started the extension part of the study. In the Intent-To-Treat (ITT) population, the median time to significant pain relief in the Fentanyl TAIFUN(R) group as measured by a decrease of at least 2 points on the numerical pain scale (NPS) was 5.2 minutes, which was statistically significantly faster when compared to placebo (P=0.007). The mean difference in sum of pain intensity difference (SPID) was also statistically significantly in favor of Fentanyl TAIFUN(R) for the whole 60 min pain episode (P=0.050). This was already seen in numerical pain scale scores up to 15 minutes (P=0.008) when compared to placebo.

"We are extremely satisfied to have demonstrated beyond doubt the faster and superior pain relief provided by Fentanyl TAIFUN(R) to patients. 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, Chief Executive Officer of Akela Pharma Inc.

Phase IIb for Fentanyl TAIFUN(R) was a multi-center, multinational clinical trial in cancer patients with severe persistent pain on main
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