This Phase I trial for the first EDACS(TM) based product is an open-label, randomized, single-dose, cross-over study investigating the pharmacokinetics and safety of 3 different extended release formulations of a well-known opioid product compared to the same opioid drug immediate release formulation. The study will be carried out in 12 healthy subjects, and the results are expected to be available in Q3/2008.
"The abuse of prescription drugs is approaching epidemic proportions in numerous countries. The costs to society associated with this abuse are tremendous. Akela has developed a platform technology to prevent the abuse of such substances by preventing the tampering of extended release dosage forms as well as unintentional dose dumping in alcohol. " said Dr. Halvor Jaeger, Chief Executive Officer of Akela Pharma Inc. "We believe that our platform technology is perfectly suited to meet the increasing market demand as well as regulatory pressure for abuse deterrent formulations."
About EDACS(TM):
EDACS(TM) is a patent pending platform technology which utilizes extrusion technology to prepare an insoluble matrix containing dispersed drug which can be shaped into tablets. The matrix is water insoluble, slightly soluble in ethanol, not friable, does not break on compression or allow for crushing and inhalation and does not allow for dissolution and injection.
About Akela Pharma Inc.:
Akela Pharma is an integrated drug development company focused on developing therapies for the growing multi-billion dollar inhalation and pain 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 11.7 million shares outstanding.
This news release contains certain forward-looking statements that reflect the current views and/or expectations of Akela Pharma Inc. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.
Source: Akela Pharma Inc.
