The buprenorphine and naloxone sublingual tablet is the first to be approved in Europe with six different strengths, according to the Sweden-based company.
“Our ambition is to make Zubsolv available to patients outside the US, and this approval is an important step in realizing this goal,” Orexo’s president & CEO, Nikolaj Sørensen, said in prepared remarks. “We look forward to continuing our journey with Mundipharma, our partner, reaching out with this unique product globally and introducing an important new option in the care of those suffering from opioid dependence.”
The therapy’s approval did not trigger a milestone payment, Orexo said, adding that it is slated to land a payment when it starts commercializing Zubsolv in Europe.
ORX shares were trading at 44.60 Swedish krona today, up 3.7%.