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UPDATE 2-FDA seeks more data on Labopharm's Tramadol
January 24, 2008 / 12:42 PM / in 10 years

UPDATE 2-FDA seeks more data on Labopharm's Tramadol

(Adds analyst’s comments)

TORONTO, Jan 24 (Reuters) - Labopharm Inc DDS.TO DDSS.O said on Thursday that the U.S. Food and Drug Administration has asked it for more information as it continues to evaluate approval for the company’s once-daily formula for the pain-reliever Tramadol.

The FDA has also suggested that the company meet with it before resubmitting another approvable letter for the Tramadol formula, Labopharm said.

“I think it’s positive that it’s moving forward, but we are still not there yet,” said Tania Maciver, a biotech analyst at Haywood Securities. “It’s kind of a modest positive outlook.”

Labopharm received notification from the FDA in May 2007 that the Tramadol treatment would not be approved until certain conditions were met.

It said that Labopharm had not demonstrated the efficacy of its formula because statistical methods used to analyze data from clinical trials did not adequately address missing data relating to those who dropped out and did not complete the study.

Labopharm said on Thursday the statistical method the FDA proposes for a new analysis of the data is different from that previously requested by the FDA.

“We are encouraged by the FDA’s recent communication and are currently evaluating the proposal outlined in the letter,” Labopharm President and Chief Executive James Howard-Tripp said in a release.

“We look forward to potentially resolving the outstanding issues.”

However, Maciver said that a few questions remain including the length of the analysis, what additional information the agency will require, and how long the review process will take.

“There is still quite a bit of risk, but it is less of a roadblock than we had before,” she said.

Labopharm shares were up 18 Canadian cents, or 19 percent, at C$1.13 at midday on the Toronto Stock Exchange after climbing as high as C$1.19 earlier in the day. ($1=$1.01 Canadian) (Reporting by Scott Anderson; Editing by Peter Galloway)

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