| TORONTO, April 8
TORONTO, April 8 Labopharm Inc's DDS.TO
lengthy struggle to get U.S. Food and Drug Administration
approval for its once-daily version of the pain killer tramadol
could be over in about four months, its president and chief
executive, James Howard-Tripp, told Reuters on Tuesday.
The company, which has been seeking the approval since May
2007, expects to meet with the director of the FDA's Center for
Drug Evaluation and Research sometime this month. After the
meeting, the FDA has another 30 days to hand down a
Once the decision is announced, the company must complete
labeling requirements, which could take 60 more days. When all
these steps are completed, an approval announcement could be
made sometime in August, Howard-Tripp said.
He said the company considered jettisoning the product at
one time due to the regulatory delays, but decided instead to
fight for approval, convinced that it had the data needed to
back its case.
"You have to be convinced that you have a good product and
you have to be convinced that you have the right data. But you
also have to be convinced that there is a fair process," he
Regulatory delays have been costly for the company and its
development partner, Purdue Pharma LLP, Howard-Tripp said. The
company expected approval in September 2006, and had prepared
for its launch in both 2006 and mid-2007.
"Through this process we have had to conduct additional
clinical trials, which at the end of the day are more trials
than normally asked for. That has cost a considerable amount of
time and money," he said.
Howard-Tripp said the delays were the result of the FDA's
decision to alter data requirements midstream. The company has
maintained that the statistical method the FDA proposed for a
new analysis of the data was different from that previously
requested by the FDA.
Labopharm argues that additional analysis, requested
recently by the agency, confirmed the efficacy of its
once-daily tramadol formulation, which was demonstrated in
previous analyses that were included in its New Drug
Application and additional submissions.
Labopharm received notification from the FDA in May 2007
that the tramadol treatment would not be approved until certain
conditions were met. At the time, the FDA said Labopharm had
not demonstrated the efficacy of its formula because
statistical methods used to analyze data from clinical trials
didn't adequately address missing data relating to those who
had dropped out and didn't complete the study.
(Editing by Peter Galloway)