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AKELA Pharma Inc. announces positive results for the extension part of its Phase IIB Fentanyl TAIFUN(R) Trial |
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06 Sep 2007 |
The results demonstrated statistically significant differences compared to placebo in the measured primary and secondary efficacy variables resulting in faster and superior pain relief
MONTREAL, Canada | September 5, 2007 | 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® 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® 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 (ITT) population, the median time to significant pain relief in the Fentanyl TAIFUN® 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® 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® 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® was a multi-center, multinational clinical trial in cancer patients with severe persistent pain on maintenance opioid therapy. The first part of the trial was a single arm, open-label dose titration to evaluate the effective individual dose for significant pain relief with Fentanyl TAIFUN® in the treatment of breakthrough cancer pain. The second part included responders from the open-label part randomized to receive the titrated doses or placebo.
Chronic pain associated with advanced cancer is commonly treated with strong opioid analgesics, such as fentanyl. Breakthrough pain episodes are sudden and intense flares of pain that “break through” a long-acting continuous treatment, such as a transdermal patch or a slow release tablet. Breakthrough pain episodes are common in cancer patients, often occurring several times a day.
About Akela Pharma
Akela Pharma is an integrated drug development company focused on developing therapies for the growing multi-billion dollar inhalation, pain and CNS markets. Its lead product, for the treatment of breakthrough cancer pain, is a fast-acting Fentanyl formulation delivered using the Company’s TAIFUN® dry powder inhaler platform. Its pipeline also includes therapeutics for asthma, COPD, growth hormone deficiencies and controlled substance abuse deterrent formulations.
Akela’s common shares trade on The Toronto Stock Exchange (“TSX”) under the symbol “AKL” with 82.3 million shares outstanding.
SOURCE: AKELA Pharma Inc.
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