Staff Writer

Labopharm Inc. said its painkiller tramadol could have a shot at getting FDA approval if it uses an analysis that the agency previously recommended, causing shares in the Canadian company to soar.

Its shares (NASDAQ:DDSS) gained 45 cents, or 34.6 percent, to close at $1.75.

Although the FDA has denied the company's most recent appeal of the agency's decision in an approvable letter, Douglas Throckmorton, deputy director of the FDA Center for Drug Evaluation and Research, suggested in a letter that there may be a regulatory path forward by submitting an analysis previously proposed in an agency letter.

That analysis, Labopharm said, could provide the needed assurance to support the efficacy of Labopharm's once-daily tramadol. Following resolution of any issues with labeling, such a finding would lead to the approval of the product, it said.

The Laval, Quebec-based company said it expects to submit a complete response to FDA before the end of the week, and the FDA has agreed to conduct its review of the response in a timely basis.

"We are encouraged by the agency's request to formally submit the data analysis that Dr. [John] Jenkins [director of FDA's Office of New Drugs] suggested we undertake and believe that this is a positive step toward regulatory approval in the U.S.," said James R. Howard-Tripp, president and CEO of Labopharm Inc., said in a statement.

Labopharm said it has completed the statistical analysis of data suggested by Jenkins and believes that the findings confirmed the conclusions of efficacy of its once-daily tramadol formulation.

Once-daily tramadol is based on the company's Contramid technology, which allows both rapid and sustained drug release and maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The company said that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy.

Under its global commercialization program, Labopharm's once-daily tramadol product has been launched in 11 countries, including the five largest markets in Europe and Canada and is approved in 19 other countries. Labopharm has licensing and distributions in place for more than 50 markets globally, including those countries in which its product has been launched.

The company also is developing controlled-release, abuse-resistant tramadol formulations that reduce the risks associated with accidental chewing or breaking of the tablets.

In addition, Labopharm is developing a Contramid-based once-daily formulation of the widely prescribed antidepressant trazodone, which is in Phase III testing; products based on both the oral an intravenous versions of its Polymeric Nano-Delivery Systems technology, as well as line extensions of its commercialized Contramid-based once-daily tramadol product. (See BioWorld Today, Feb. 11, 2008.)