Abstral fentanyl regulatory update

Orexo said partner Kyowa withdrew a Japanese NDA for Abstral sublingual fentanyl (KW-2246) to treat breakthrough cancer pain after the Pharmaceutical and Medical Devices Agency of the Japanese Ministry of Health Labor and Welfare 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. ...