Labopharm to Present Poster on Dose Titration of Once-dailyTramadol at 3rd International Forum on Pain Medicine- Article Discussing Pharmacokinetics and Dose Proportionality of Company's Once-Daily Tramadol to be Published in Biopharmaceutics Journal -
LAVAL, QC, June 29, 2007 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that it will present a poster discussing the dose titration of its once-daily formulation of tramadol at the 3rd International Forum on Pain Medicine to be held June 28 to July 1, 2007 in Montreal, Canada.
The poster compares two different titration schedules for Labopharm's once-daily formulation of tramadol in three Phase III clinical trials: a six-day titration to a 300 mg dose (clinical trials MDT3-002 and MDT3-003) and a nine-day titration to a 300 mg dose (clinical trial MDT3-005). The comparison showed that percentage of adverse events and discontinuations due to adverse events was similar regardless of the titration schedule.
These results, in addition to the fact that Labopharm's once-daily tramadol formulation achieves steady state plasma levels after two days, suggest that a shorter titration schedule may be adequate for most patients. A previous study showed that most patients achieve pain control using Labopharm's once-daily tramadol at a dose of 200 mg. The data in this poster suggest that, for most patients, after starting with a dose of 100 mg for two days, the therapeutic dose of 200 mg could be achieved after two days without increased risk of side effects. If a patient requires a higher dose (300 mg), the therapeutic dose could be achieved after six days of titration (100 mg for 2 days; 200 mg for 3 days then 300 mg on the 6th day) without increased risk of side effects.
"The results of the comparison of titration periods reviewed in the poster suggest that patients may benefit from rapid titration to optimal analgesia without increased risk of side effects using our product," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "The ability to quickly titrate patients to the optimal dose will be an important competitive strength for our product in the marketplace."
In addition, representatives of the Company will be at Labopharm's corporate booth to promote its once-daily tramadol product to medical professionals from around the world, as well as to generate awareness of Labopharm's drug optimization technologies.
Labopharm also announced today that an article discussing the Company's study to characterize the pharmacokinetics and to assess the dose proportionality of 100 mg, 200 mg and 300 mg strengths of its once-daily formulation of tramadol will be published in the September 2007 edition of the journal Biopharmaceutics and Drug Disposition (Volume 28, Issue 6, Pages 323-330).
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company has a robust pipeline of follow-on products in both pre-clinical and clinical development.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process and the commercialization of the Company's products, if they are approved, specifically, the adoption of such products by physicians and patients.. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.
Posted: June 2007