Meda has got approval for Breakyl (fentanyl) in Europe via the Decentralized Procedure with Germany acting as Reference Member State.
Breakyl (also known as Onsolis or BEMA Fentanyl) is indicated for the management of pain in opioid tolerant adult patients with cancer.
Meda claims that Breakyl uses a unique patented delivery system designed to ensure rapid and reliable delivery of fentanyl.
Breakyl comes with a small dissolvable film which can be applied to the buccal (inner lining of cheek) membranes.
Breakyl has recently also been approved in Canada and the US under the trademark Onsolis.
Meda expects to get marketing authorisations approval in major European countries for Breakyl, throughout next year.
Meda CEO Anders Lonner said that they are pleased with this achievement and look forward making Breakyl available to patients across Europe who are afflicted with this indication.
“There is a growing medical need and Breakyl offers a unique and patented delivery technique compared with current treatment alternatives,” Lonner said.