ARTICLE | Clinical News

Breakyl regulatory update

October 25, 2010 7:00 AM UTC

BioDelivery Sciences and Meda said an MAA for Breakyl BEMA fentanyl to manage breakthrough cancer pain in opioid-tolerant adults received approval via the European decentralized procedure, with Germany acting as the reference member state. The partners are expecting national marketing authorization approvals in each of 25 individual EU countries over the next several months, with an anticipated launch before the end of 2011.

BioDelivery is eligible for a $2.5 million milestone payment from Meda upon the first national marketing authorization of Breakyl. BioDelivery also is eligible for a $2.5 million milestone payment upon the first commercial sale. ...