Orexo’s partner, ProStrakan has submitted to FDA the New Drug Application (NDA) for Abstral, for the treatment of breakthrough cancer pain in opioid-tolerant patients.
The company said that the filing of Abstral will generate a milestone payment as part of the agreement with ProStrakan for North America, that in total, can give $27 million in certain regulatory and sales milestone payments. In addition, Orexo will receive royalties on product sales.
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.
Torbjorn Bjerke, president and CEO of Orexo, said: “This submission is the first stage of bringing Abstral to the thousands of patients in the US we believe will benefit from this novel, convenient and effective treatment. 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.”