(Adds analyst's comments)
TORONTO Jan 24 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
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
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
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
"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.
(Reporting by Scott Anderson; Editing by Peter Galloway)