Labopharm has initiated the regulatory approval process for its twice-daily Tramadol-Acetaminophen formulation in Europe under the decentralised procedure (DCP).
According to DCP, Labopharm has submitted a marketing authorisation application (MAA) with a Reference Member State (Iceland), which will provide an assessment of the MAA file to the company’s list of Concerned Member States.
Labopharm is responsible for obtaining regulatory approval in most of the countries included in the distribution and supply agreement with Grunenthal and is seeking approval in those countries. The regulatory authorities of both Reference Member State and Concerned Member States will achieve consensus regarding approval of the product and all Member States grant national marketing authorisations based upon that consensus decision.
The DCP is expected to take approximately one year to complete and national marketing authorisations will be provided thereafter.
Tramadol-Acetaminophen products leverage the complementary modes of action of each of the active ingredients to provide the analgesic strength of a mild opioid (Tramadol) and the rapid pain relief of Acetaminophen. Tramadol-Acetaminophen combination products were first launched in 2001 in the US and in 2003 in other major markets around the world.
Labopharm’s formulation of Tramadol-Acetaminophen is based on its Contramid controlled-release technology, which provides patients with both rapid pain relief and analgesic strength in a sustained-relief analgesic. The company’s twice-daily formulation of Tramadol-Acetaminophen is designed to provide improved patient benefit by controlling the release of the two active ingredients simultaneously, thereby providing both immediate and sustained relief of acute pain.
James Howard-Tripp, president and chief executive officer of Labopharm, said: “Initiating the regulatory approval process in Europe builds on our recently established marketing partnership with Grunenthal GmbH. It is our intention to commercialise our twice-daily Tramadol-acetaminophen formulation in key markets around the world. To this end, we are both preparing to submit additional regulatory applications in 2010 and pursuing marketing partners in key regions around the world.”