ARTICLE | Company News

Kyowa pulls Japanese Abstral NDA

August 27, 2010 11:48 PM UTC

Orexo AB (SSE:ORX) said partner Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) withdrew a Japanese NDA for Abstral sublingual fentanyl ( KW-2246) to treat breakthrough cancer pain after Japan's Pharmaceuticals and Medical Devices Agency asked for an additional Japanese Phase III trial using the dose-titration regimen used in U.S. and European Phase III trials. Kyowa had submitted data from a Japanese trial using a different dosing regimen. Orexo said it expects completion of the trial to take about a year, after which the NDA will be resubmitted. ...