Akela Pharma Inc., a drug development company focused on developing therapies for the inhalation, pain and CNS markets, has completed enrolling patients in its Fentanyl Taifun phase IIb trial. Fentanyl Taifun is a fast-acting Fentanyl formulation delivered using the company's Taifun dry powder inhaler platform.
Phase IIb for Fentanyl Taifun is a multi-cantered, multinational clinical trial in cancer patients with severe persistent pain on maintenance opioid therapy. The first part of the trial is 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 includes 28 responders from the open-label arm randomized to receive the titrated doses or placebo. The safety and efficacy data from this double-blind, placebo-controlled extension arm is expected to be available by early September 2007.
"The completion of patient enrolment in our Fentanyl Taifun phase IIb marks yet another important milestone achievement in the development of our lead compound. We confidently anticipate being able to demonstrate once again the same superior formulation, technological platform and unique therapeutic profile." said Dr Halvor Jaeger, CEO of Akela Pharma Inc.
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. Break-through pain episodes are common in cancer patients, often occurring several times a day.