LAVAL, QC, Sept. 29 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS, NASDAQ: DDSS) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for its once-daily formulation of tramadol.
In its letter, the FDA indicated that Labopharm’s once-daily formulation of tramadol is approvable subject to the resolution of certain issues. The Company plans to discuss the letter with the FDA as soon as possible and believes that it can address the issues raised in the letter without the need for additional data. Potential outcomes with respect to resolution of the issues range from utilization of current data to the need to generate additional data.
“We plan to work closely with the FDA to resolve the outstanding issues and obtain final approval,” said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. “We will provide further information following discussions with the FDA and clarification of the path forward.”
Labopharm’s New Drug Application (NDA) for its once-daily formulation of tramadol was submitted to the FDA in November 2005. The NDA included data from the Company’s global clinical development program including six Phase III clinical studies and 12 pharmacokinetic studies. Combined, more than 2400 patients have been exposed to the product in clinical studies.
About Labopharm Inc.
Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) is an international, specialty pharmaceutical company focused on the development of drugs incorporating Contramid®, the Company’s proprietary advanced controlled-release technology. Labopharm’s lead in-house product, a once-daily formulation of the analgesic tramadol, has received regulatory approval in 22 European countries and commercial launch of the product across Europe is underway. In the U.S., the Company has received an Approvable Letter from the FDA and is working with its marketing partner for the U.S., Purdue Pharma, to prepare for the launch of the product upon final approval. The Company’s pipeline includes a combination of in-house and partnered programs with products both in clinical trials and in preclinical development. For more information, please visit www.labopharm.com.
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.
Source: Labopharm Inc.
