TORONTO, April 8 (Reuters) - 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 decision.
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 said.
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)