Labopharm (DDS) expects to submit response this week.
Shares of Labopharm Inc. (TSX: T.DDS, Stock Forum) soared 41.3% Monday morning to $1.88, after the company announced that it had received a response from the U.S. Food and Drug Administration regarding its most recent appeal of the decision for its once-daily tramadol formulation through the formal dispute resolution process.
Procedurally, says Labopharm, “Dr. Douglas Throckmorton, M.D., the FDA's Deputy Director, Center for Drug Evaluation and Research, agreed with Dr. Jenkins, M.D., Director for the Office of New Drugs, Center for Drug Evaluation and Research and denied the appeal.” However, he suggested a regulatory path forward, namely that the company submit the analysis put forward by Dr. Jenkins. In the response, the FDA has concluded that a positive finding using this analysis could provide the needed assurance to support the efficacy of Labopharm's product.
Following resolution of any issues with labeling, such a finding would lead to the approval of the product, says Labopharm.
The company says it expects to submit the complete response before the end of the week and the FDA has agreed to conduct its review of the response in a timely basis.
The company’s once-daily tramadol product “provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief,” says Labopharm’s news release.
