Orexo (STO:ORX) touted results today from a 20-person pharmacokinetic study of its OX124-001 naloxone nasal spray. The company’s product is designed to reverse opioid overdoses. In the PK study, Orexo compared its drug to Narcan – the market-leading naloxone rescue medication. Sweden-based Orexo reported that all formulations of OX124 were well-tolerated by study participants and showed […]
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Orexo nabs regulatory win for fast-dissolving opioid dependence therapy
Orexo (STO:ORX) said today that the European Medicines Agency granted marketing authorization for its Zubsolv rapidly-disintegrating treatment for opioid dependence. 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 […]
Fast-dissolving opioid dependence tablet wins EU recommendation
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 […]
