Paladin Labs Inc. and Labopharm Inc. announced the Canadian launch of Tridural once-daily tramadol product. Tridural is a unique treatment option developed as a first-line therapy for adult patients with moderate pain who require treatment for several days or more that provides 24-hour pain relief from a single tablet taken once-daily.
Tridural is based on Labopharm's proprietary controlled-release technology, Contramid, and a novel dual matrix delivery system that facilitates both rapid and sustained drug release, maintaining therapeutic blood levels of tramadol for a full 24-hour period. Tridural offers physicians and patients greater treatment flexibility based on its relatively rapid two-day titration schedule, which could help patients reach their optimum daily dose faster than any other approved once-daily tramadol product and quickly achieve effective pain relief. In addition, Tridural has a demonstrated safety profile based on clinical trial experience of more than 2,400 patients globally and almost two years of commercial experience. As a tramadol product, Tridural provides pain relief through its action at three sites related to analgesic activity: the microns-opioid receptor, the serotonin receptor, and the norepinephrine receptor.
"The largest component of the pain market is composed of patients with persistent, moderate pain. Tridural is a new treatment option that specifically addresses this large group. Based on our market research, Tridural has some unique advantages over its competitors. We are excited to launch Tridural to the benefit of Canadian patients," said Jonathan Ross Goodman, President and chief executive officer of Paladin Labs Inc.
"Tridural's competitive strengths - full 24-hour pain relief, titration flexibility and demonstrated safety profile - are directly attributable to Labopharm's Contramid technology, which was developed to optimize the performance of existing drug products," said James R. Howard-Tripp, president and chief executive officer, Labopharm Inc. "As a Contramid technology-based product, Tridural will be significantly differentiated in the marketplace."
Tramadol is a centrally acting analgesic for the treatment of moderate to severe pain. Tramadol has a 30-year history of efficacy and safety and is currently marketed in more than 70 countries worldwide, primarily in formulations that require multiple doses per day. Studies have shown that tramadol provides relief from both acute and chronic pain conditions, including osteoarthritis pain, low back pain, cancer pain, post-operative pain and dental pain. Tramadol avoids the potentially serious side effects such as gastrointestinal bleeding that may be caused by NSAIDs and the potential cardiovascular events recently attributed to COX-2 inhibitors. Compared to stronger opioids, tramadol has, in clinical studies, demonstrated a lower incidence of major side effects, such as respiratory depression.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally.