Ryzolt
Generic name: tramadol
Treatment for: Pain
Labopharm Meets with FDA to Discuss Second Approvable Letter forOnce-daily Tramadol
LAVAL, QC, June 29, 2007 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that it has met with the U.S. Food and Drug Administration (FDA) to discuss the matters raised in the Agency's May 30, 2007 Approvable Letter for the Company's once-daily formulation of tramadol. The Company believes that the meeting with the Agency was productive and that the statistical analysis required by the FDA to achieve approval has been clearly delineated. If the existing data cannot satisfy these statistical requirements, the Company would be required to generate new data through an additional Phase III clinical trial. Labopharm will provide additional updates as it continues to interact with the FDA, as well as work with its marketing partner for the U.S., Purdue Pharma, and its advisors.
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 that involve a number of risks and uncertainties relating to the Company's once-daily tramadol product in the United States that could cause actual results to differ materially from those indicated in the forward looking statements. These statements reflect the Company's current expectations regarding future events. Specifically the risks and uncertainties the Company faces include but are not limited to: the Company's ability to resolve the issues identified by the FDA to the FDA's satisfaction in a timely manner; the uncertainties related to the regulatory process, including regulatory approval, and the commercialization of the drug thereafter. There can be no assurance that the Company will be able to resolve the issues identified by the FDA using existing data, or at all. If the Company is unable to resolve the issues identified by the FDA using existing data, it would need to generate additional data in order to obtain FDA approval. The Company's once-daily formulation of tramadol may not be legally marketed in the United States prior to approval by the FDA. 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
Related articles
- Labopharm Announces FDA Approval of Once-Daily Ryzolt for Moderate to Moderately Severe Chronic Pain - December 31, 2008
- FDA Accepts Labopharm's Response for Once-Daily Tramadol asComplete Class 2 Response - July 17, 2008
- Labopharm Submits Complete Response to FDA as a Result of Outcomeof Appeal Process for Once-Daily Tramadol - July 3, 2008
- Labopharm Receives Response from FDA Regarding its Once-DailyTramadol Product - June 30, 2008
- Labopharm Appeals FDA's Decision on Once-Daily Tramadol to NextSupervisory Level After Additional Analysis Supports Efficacy - April 1, 2008
- Labopharm Receives FDA Response to Recent Appeal of ApprovableLetter For Once-Daily Tramadol - January 24, 2008
- Labopharm Appeals FDA's Decision on Once-Daily Tramadol - October 15, 2007
- Labopharm Provides Update on U.S. Regulatory Process for Once-DailyTramadol - September 25, 2007
- Labopharm Receives Second Approvable Letter from FDA for Once-DailyTramadol - June 1, 2007
Ryzolt (tramadol) FDA Approval History
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