Mundipharma International and Orexo (STO:ORX) said today that its fast-dissolving Zubsolv buprenorphine and naloxone sublingual tablet won a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The European Commission is slated to make a final decision about the product’s marketing authorization by the end of this year, the companies reported.
The product is designed to treat people with opioid use disorder. If it wins approval, it will be the first fast-dissolving tablet available in six different strengths, according to the companies. The formulation was developed to be abuse-deterrent.
“This positive opinion is an important step for our collaboration with Orexo, and we are committed to working with them to make this important treatment available to patients in Europe,” Rachel Gooch, Mundipharma’s head of addiction therapy, said in prepared remarks. “Opioid dependency is a chronic condition, where new options are very much needed, particularly if they can deter misuse. We very much look forward to being able to support the clinical community and their patients in this underserved area of medicine by offering an alternative treatment option.”
“Together with our partner Mundipharma, our ambition is to make Zubsolv available to patients outside the US. The positive CHMP opinion is important progress towards approval to bring Zubsolv to patients suffering from opioid dependence in Europe,” Orexo president & CEO Nikolaj Sørensen added. “I am very pleased with the collaboration with Mundipharma and I look forward to our continuing journey to reach out with this unique product globally. We also share Mundipharma’s commitment to addressing unmet patient needs in opioid dependence, and we remain proud they have chosen to commercialise Zubsolv with us.”
Under the terms of a deal that Munidpharma and Orexo struck last year, Orexo will receive a milestone payment for an undisclosed amount if the EU approves the product and the companies start commercialization.
ORX shares were trading at $34.80 apiece today at close, up 5.5%.