ProStrakan submit NDA for Abstral to FDA

Orexo AB has announced that its partner, UK-based international speciality pharmaceutical company ProStrakan Group, has submitted a New Drug Application (NDA) for Abstral to the US Food and Drug Administration (FDA).

The filing of Abstral (for the treatment of breakthrough cancer pain in opioid-tolerant patients) will result in $27m in certain regulatory and sales milestone payments for Orexo as part of the agreement with ProStrakan for North America. In addition, Orexo will receive royalties on product sales. ProStrakan is also Orexo's partner for Abstral in Europe.

Commenting on the filing, Torbjörn Bjerke, Orexo's president and CEO, said: "This submission is the first stage of bringing Abstral to the thousands of patients in the USA we believe will benefit from this novel, convenient and effective treatment. The US market is the world's largest market for breakthrough cancer pain with the number of breakthrough cancer pain attacks amounting to approximately 376 million per year."

The filing of Abstral has yet to be validated by the FDA before being accepted for review, and therefore no Prescription Drug User Fee Act (PDUFA) date has yet been assigned.