The NDA for BEMA Fentanyl submitted in the US

Today, the NDA (New Drug Application) for BEMA Fentanyl was submitted to the FDA (Food and Drug Administration) in the US.

Meda has exclusive rights to the specialty product BEMA Fentanyl in the US, Europe, Canada and Mexico.

BEMA Fentanyl, inlicensed from BioDelivery Sciences International Inc (BDSI), is patented with a unique delivery system designed to give rapid and reliable delivery of fentanyl for treatment of breakthrough pain in cancer patients. The product consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal (inner lining of cheek) membranes. BEMA Fentanyl has shown in clinical studies important patient advantages compared to competing products.

“Our ambition with this unique product within the breakthrough cancer pain indication is to reach well over USD 200 million in yearly sales in the US only. Our US marketing organisation has good experience in the pain area and is well acquainted with the target group.”, says Anders Lonner, CEO Meda AB

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