Orexo AB Announces Positive Results From Human PK Study Assessing Orexo's New Intranasal Naloxone Formulations for Opioid Overdose Reversal
January 07, 2019 at 12:48 pm IST
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Orexo AB (publ) announced positive results from the human pharmacokinetic (PK) study OX124-001 in 20 healthy volunteers, assessing Orexo's novel naloxone nasal spray formulations intended for opioid overdose reversal. The study was a cross-over, comparative, bioavailability study comparing four development formulations of OX124 to Narcan Nasal Spray 4mg, the current market-leading naloxone rescue medication in the US. All formulations of OX124 were well tolerated and showed substantially higher plasma concentrations of naloxone, sustained duration of elevated plasma concentrations, and equivalent or superior onset time when compared to Narcan. Highly potent synthetic opioids such as fentanyl have become the leading cause of death following drug overdoses in the US, with nearly 30,000 fatalities in 2017. Currently available naloxone-based rescue medications struggle to reverse effects of such opioids. Orexo believes that the present results for OX124 will allow for the development of a proprietary rescue medication capable of reversing any overdose, irrespective of which type of opioid has caused it. The next step for OX124 is to continue to further optimize the formulation and prepare for a pivotal pharmacokinetic bridging study in consultation with the US Food and Drug Administration, FDA. The positive study results will also enable Orexo to accelerate development of the Company's second differentiated rescue drug candidate, OX125, which contains the active substance nalmefene. Assuming further successful development, Orexo expects to file OX124 and OX125 with FDA in 2021 and 2022, respectively.
Orexo AB is a Sweden-based company active within the pharmaceutical industry. It focuses primarily on the development of new, patented drugs by combining documented substances with technologies, and the new treatments for respiratory and inflammatory diseases. The Company has four commercialized products, several projects developed in partnership, as well as three development programs. The Company's registered products are: Abstral for the treatment of break through cancer pain, sold by ProStrakan Group plc in Europe, the United States and Canada; the sleeping pill Edluar, sold by Meda in the United States and Canada; as well as two products for the diagnosis of Helicobacter pylori which are being marketed by the subsidiary, Kibion AB. The Company operates through subsidiaries: Pharmacall AB, Noster System AB, Orexo UK, and Pharmakodex Ltd, among others. In December 2013, Kyowa Hakko Kirin Co., Ltd (KHK), with the licensed right to Abstral, commenced the launch of it in Japan.