Cephalon submits OraVescent NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cephalon submits an NDA for its effervescent buccal fentanyl product OraVescent. Announced Sept. 6, the application seeks an indication for management of breakthrough pain in patients with cancer who are already receiving or who are tolerant to opioid therapy for underlying persistent pain. "This NDA, submitted on schedule, is the fourth of five new product opportunities that Cephalon is pursuing over a 15-month period," the firm said. Cephalon previously indicated that its goal of achieving four NDA approvals in 2005-2006 could double the firm's size by 2008 (1Pharmaceutical Approvals Monthly May 2005, p. 13). The OraVescent NDA includes one pivotal trial with statistically significant pain improvements and interim analyses from three ongoing Phase III trials in opioid-tolerant patients...