Swedish Specialty Pharmaceutical Company Orexo AB Announced Today the Submission of a New Drug Application for Zubsolv™ (OX219) to the FDA
Published: Sep 06, 2012
UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: Orexo (STO:ORX) is the first company to submit a New Drug Application (NDA) for a novel combination product of buprenorphine and naloxone for treatment of opioid dependence, a condition affecting over two million Americans. The development of Zubsolv (OX219), a product comprising buprenorphine and naloxone based on Orexo’s proprietary sublingual drug delivery technology, has progressed well and faster than originally anticipated. A total of four clinical studies were completed in support of the filing, along with a CMC product stability program covering two independent manufacturing sites.