LAB REPORTS FAVORABLE PROFILE OF FENTANYL PRODUCT

Lab International has announced positive results from the open-label arm of its Fentanyl Taifun Phase IIb clinical trial. The results from the 24-patient study demonstrated successful dose titration resulting in effective control of breakthrough pain episodes. Fentanyl Taifun is a fast-acting fentanyl formulation delivered using the company's Taifun dry-powder inhaler platform.

The trial was a multicenter, 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 study to evaluate the effective individual dose for significant pain relief with Fentanyl Taifun in the treatment of breakthrough cancer pain. The second part included 28 responders from the open-label arm randomized to receive the titrated doses or placebo. The double-blind, placebo-controlled extension arm, which is currently underway, is expected to be completed before the end of the second quarter of 2007.

All 24 patients were successfully titrated to a dose of 400 micrograms or less. The patients experienced significant pain relief (defined as a decrease of at least 2 points on the Numerical Pain Scale) in 95 percent of the pain episodes treated. The estimate of the median time to significant pain relief was seven minutes. Based on the interim adverse event data, Fentanyl Taifun doses have been well tolerated, and adverse events recorded were in accordance with previously disclosed data, therefore suggesting high tolerability of Fentanyl Taifun in opioid-tolerant cancer patients.

The excellent titration success and very fast onset of action obtained with Fentanyl Taifun compares very favorably with data published from trials on transmucosal fentanyl preparations, according to the company. The apparent opioid-sparing effect of Fentanyl Taifun is most likely due to the unique pharmacokinetic profile of the product, which combines an essentially immediate absorption of the drug with a prolonged and relatively steady concentration for the duration of a typical breakthrough pain attack.