Labopharm Inc announced the initiation of two Phase III clinical trials in the U.S. for its lead in-house product, a once-daily formulation of Tramadol. Currently available in the U.S. only in immediate-release forms that require dosing four to six times daily, Tramadol generates annual U.S. sales of approximately US$740 million.

Labopharm is conducting two double blind, multi-centre, randomized trials to evaluate the efficacy of once-daily Tramadol in reducing moderate to moderately severe pain in patients suffering from osteoarthritis. The subject population will include men and women aged 40 to 75 and patient dosing will last for 12 weeks. The Company expects to complete the trials by the end of 2003, and the U.S. trial data, in conjunction with the data from ongoing and completed studies, will form the New Drug Application (NDA) filing to the FDA.

"The on schedule initiation of the U.S. studies represents another major step forward in our efforts to bring Tramadol to market globally," said James R. Howard-Tripp, President and CEO of Labopharm. "Consistent with our plan, we expect to file a drug registration dossier in Europe in the first quarter of 2003 followed by an NDA filing in the U.S. by the end of the year."

Tramadol is a centrally acting analgesic indicated for moderate to moderately severe pain, which may be associated with such conditions as osteoarthritis, lower back spasm, and other chronic conditions. It reduces pain by binding to u-opioid receptors and by inhibiting the re-uptake of the neurotransmitters norepinephrine and serotonin, offering a unique advantage over other analgesics.

Howard-Tripp noted, "Because Tramadol is well tolerated compared to anti-inflammatory drugs, it can be used by patients who are at risk of developing gastrointestinal bleeding and those with kidney problems. We look forward to bringing the convenience of once-daily dosing of Tramadol's proven therapeutic benefits to these and other patients." Current worldwide sales of Tramadol are estimated to be in excess of US$1.3 billion annually.