LAB INTERNATIONAL ANNOUNCES POSITIVE PRELIMINARY RESULTS FROM TAIFUN TRIAL

LAB International has announced positive preliminary results from an additional comparative Phase I trial for its lead product, Fentanyl TAIFUN, for the treatment of cancer-related pain. The study was conducted in 32 healthy volunteers to obtain additional pharmacokinetic data, and examine dose proportionality using single doses of 100-800 (micro)g of Fentanyl TAIFUN. The study also compared the pharmacokinetics of Fentanyl TAIFUN with Actiq 200 mcg, the commercially available Fentanyl lozenge.

The study results indicate that the absorption of fentanyl after a single inhalation of 200 mcg of Fentanyl TAIFUN was very rapid, with an average peak concentration of 935 pg/ml reached in one minute. Comparatively for the 200 mcg Actiq lozenge, the average peak concentration of 371 pg/ml was reached one hour after the start of administration of the lozenge. Subsequent to the rapid peak with the Fentanyl TAIFUN, the concentration dropped within the first 15 minutes to a plateau at the same level as compared to the peak obtained with Actiq, the plateau lasted at least one hour after the administration.