Aachen- Germany- January 25- 2008. The German pain specialistGrunenthal GmbH announces that a New Drug Application (NDA) hasbeen submitted to the U.S. Food and Drug Administration (FDA) fortapentadol immediate release (IR) tablets by its co-developmentpartner Johnson amp; Johnson Pharmaceutical Research amp;Development- L.L.C. (J amp;JPRD). Tapentadol is an oral centrallyacting analgesic and will be the first new substance in its classfor more than 25 years after successful registration. In theEuropean Union- tapentadol is currently in phase 3 of thedevelopment program for severe acute pain- and the Company plans tosubmit it for approval later this year.
Tapentadol acts by two mechanisms of action- combining mu-opioidreceptor agonism and noradrenaline reuptake inhibition propertiesin a single molecule. It is in development as immediate-release andprolonged-release formulations. When approved- it will be used inhospital and outpatient settings.