Mundipharma has signed an agreement with Swedish-based pharmaceutical company Orexo to grant exclusive global (ex-US) rights to Mundipharma’s network of independent associated companies for Zubsolv (buprenorphine and naloxone sublingual tablet), for the treatment of patients outside the US with opioid dependence.

The launch of Orexo’s Zubsolv in worldwide markets outside the US will help increase its production volumes, and also provide a greater choice of therapies to patients and clinicians managing addiction to opioids, such as heroin.

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Mundipharma International president and CEO Antony Mattessich said: "We’re very excited about this new collaboration and the opportunity to realise the potential of Zubsolv to help patients and healthcare professionals manage opioid dependence with a combination product that is designed to deter misuse."

Zubsolv (buprenorphine and naloxone) is licensed in the US for the treatment of opioid dependence and administered in patients as part of a comprehensive treatment plan, which includes counselling and psychosocial support.

"Mundipharma has shown a strong commitment to become a leader in the treatment of opioid dependence and I am proud they have selected to commercialise Zubsolv."

Orexo CEO Nikolaj Sørensen said: "I am very pleased that Zubsolv soon could have a more global reach.

"Mundipharma has shown a strong commitment to become a leader in the treatment of opioid dependence and I am proud they have selected to commercialise Zubsolv."

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Under the agreement, Orexo receives an upfront payment of €7m.

Zubsolv will be submitted to the European Medicine Agency (EMA) for marketing authorisation, pending the completion of a registrational bioequivalence study compared to a reference product Suboxone tablet (buprenorphine and naloxone).

Regulatory filings in other ex-US territories are also planned.

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