Orexo AB announced that its partner, UK-based international specialty pharmaceutical company ProStrakan Group plc, has submitted the New Drug Application (NDA) for Abstral (for the treatment of breakthrough cancer pain in opioid-tolerant patients) to the US Food and Drug Administration (FDA).
The filing of Abstral will generate a milestone payment to Orexo as part of the agreement with ProStrakan for North America that in total can give USD 27 million in certain regulatory and sales milestone payments. In addition, Orexo will receive royalties on product sales.
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. We are excited about the prospect of a US launch of Abstral by ProStrakan, Orexo's partner for Abstral in both North America and Europe."
The filing of Abstral has yet to be validated by the FDA before being accepted for review, and therefore no PDUFA date has yet been assigned.
Abstral is a fast-dissolving tablet for sub-lingual administration of fentanyl, intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics.
Orexo is a pharmaceutical company focusing on developing treatments for pain and inflammation.