LAVAL, Qc, Oct. 26 /PRNewswire-FirstCall/ - LAB International Inc. (“LAB”), an integrated drug development company with subsidiaries focused on developing therapies for the inhalation market and on providing contract research services, today announced positive preliminary results from an additional comparative Phase I trial for its lead product, Fentanyl TAIFUN(R). 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(R). The study also compared the pharmacokinetics of Fentanyl TAIFUN(R) with Actiq(R) 200 (micro)g, the commercially available Fentanyl lozenge.
The study results indicate that the absorption of fentanyl after a single inhalation of 200 (micro)g Fentanyl TAIFUN(R) was very rapid, with an average peak concentration of 935 pg/ml (geometric mean Cmax) reached in one minute (median Tmax). Comparatively for the 200 (micro)g Actiq(R) lozenge, the average peak concentration of 371 pg/ml (geometric mean Cmax) was reached one hour (median Tmax) after the start of administration of the lozenge. Subsequent to the rapid peak with the Fentanyl TAIFUN(R), the concentration dropped within the first 15 minutes to a plateau at the same level as compared to the peak obtained with Actiq(R), the plateau lasted at least one hour after the administration. The profile observed indicates instantaneous alveolar (deep lung) absorption, followed by absorption from other parts of the airways, the throat, and to some extent the GI-tract.
The time from the start of a break-through pain episode to the peak of the pain intensity is typically very short, on average only a few minutes as reported by Portenoy et al (Pain 81, 129-134, 1999). Accordingly, the bioavailability of fentanyl during the early part of the pharmacokinetic curve is of special importance. The bioavailability of Fentanyl TAIFUN(R) as indicated by the AUC0-20min (geometric mean area under the curve during the first 20 minutes from the start of the administration) and AUC0-30min of fentanyl with Fentanyl TAIFUN(R) was 140 h(x)pg/ml and 202 h(x)pg/ml, respectively, as compared to 17 h(x)pg/ml and 51 h(x)pg/ml, respectively, with Actiq(R). This corresponds to an eight-fold and four-fold relative bioavailability of fentanyl in the circulation during the first 20 and 30 minutes, respectively, a period that is critical to an analgesic response in an intensive but usually relatively short lasting pain attack.
“We have clearly demonstrated once again that Fentanyl TAIFUN(R) is the only non-injectable formulation to achieve analgesic plasma levels within the first few minutes after administration. The rapid peak in plasma concentration is the key characteristics for a successful breakthrough cancer pain reliever and would certainly constitute a significant improvement for patients over currently available therapeutics,” said Dr. Halvor Jaeger, Chief Executive Officer of LAB International Inc.
There were no unexpected local pulmonary adverse events observed. Since all administrations were given under opioid antagonist protection, the study will not be used for the evaluation of systemic safety of the product. The analysis of dose proportionality between the doses of 100-800 (micro)g using Fentanyl TAIFUN(R) is ongoing and will be reported separately.
About LAB International
LAB International (LAB Pharma and LAB Research) is an integrated drug development company. LAB Pharma is focused on the growing multi-billion dollar inhalation market. Its lead product, for the treatment of breakthrough cancer pain, is a fast-acting Fentanyl formulation delivered using the Company’s TAIFUN(R) dry powder inhaler platform. Its pipeline also includes therapeutics for asthma, COPD, and growth hormone deficiencies. LAB Research is a profitable and growing contract research services division supporting its clients base from state-of-the-art facilities in Canada, the US, Denmark and Hungary.
LAB’s common shares trade on The Toronto Stock Exchange (“TSX”) under the symbol “LAB”, on the Frankfurt Regulated Unofficial Market under the symbol “LD9.F” and on XETRA under the symbol “LD9.DE” with 56.0 million shares outstanding.
This news release contains certain forward-looking statements that reflect the current views and/or expectations of LAB International 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.
LAB INTERNATIONAL INC.
CONTACT: visit LAB’s website at www.labinc.ca, or contact: Luc Mainville,Chief Operating Officer, (450) 973-2240, ext. 1206, Fax: (450) 973-2259,mainvillel@labinc.ca; Frederic Dumais, Director, Communication and InvestorRelations, (450) 973-2240, ext. 1207, Fax: (450) 973-2259,dumaisf@labinc.ca; Kim Sutton Golodetz, Investor Relations (U.S.A), (212)838-3777, Fax: (212) 838-4568, kgolodetz@lhai.com
