Mundipharma and Orexo Submit MAA for Zubsolv

Mundipharma and Orexo together announced they have submitted a Marketing Authorisation Application (MAA) for Zubsolv sublingual tablet to the European Medicines Agency (EMA). The medication is intended to treat opioid dependence.
According to the press release:

“The submission will not trigger any new financial milestones. However Mundipharma is compensating Orexo for specific expenses related to the work required to prepare the submission. The next milestones are pending marketing authorisations and commercialisation of Zubsolv. Orexo is also entitled to receive tiered royalties on future net sales.”

Orexo’s CEO, Nikolaj Sørensen, said:

“Opioid dependence is a growing concern globally and with the unique novel product characteristics of Zubsolv such as fast dissolve time, six unique strengths to suit individual patients’ needs and strong patient preference, I am certain Zubsolv could be a welcome alternative for European physicians treating opioid dependence.”

Read the full press release here.