Nycomed submits application for Daxas

Nycomed has submitted a marketing authorisation application for Daxas (roflumilast).

The drug, which is a treatment aimed at those with chronic obstructive pulmonary disease (COPD) with chronic bronchitis, is taken once daily.

The company announced it had filed the relevant papers with the European Medicines Agency based on four phase III trials ? two of which met their primary endpoints.

Another two studies proved Daxas’ efficacy when taken with standard bronchodilator treatments.

Nycomed’s chief executive officer Haka Njorkland said the development was a “significant milestone”.

“Daxas represents a potentially important new approach in the management of COPD which is predicted to become the third leading cause of death worldwide by 2030,” he added.

In related news, Nycomed’s Instanul (intranasal fentanyl spray) was given a positive opinion last month by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

This product is aimed at managing adult cancer patients’ breakthrough pain if they are already no opioid therapy.