Topline outcomes present constructive outcomes for the experimental intranasal nalmefene product OX125 (Orexo) for opioid overdose reversal, the producer introduced earlier right this moment.
A crossover, comparative bioavailability examine was carried out in wholesome volunteers to evaluate nalmefene absorption of three improvement formulations of OX125. Preliminary outcomes confirmed “intensive and fast absorption” throughout all three formulations versus an intramuscular injection of nalmefene, Orexo reported.
“Because the US heroin disaster has developed to a fentanyl disaster, the medical want for novel and extra highly effective opioid rescue drugs is huge,” Nikolaj Sørensen, president and CEO of Orexo, stated in a press launch.
“The necessity has additionally escalated as a result of COVID-19 pandemic as the results of social distancing and financial weak point are anticipated to result in a big enhance in psychological well being points and substance use problems,” Sørensen added.
Robert Rönn, vp and head of R&D at Orexo, famous in the identical launch that the corporate will now be working with the US Meals and Drug Administration “to determine the optimum path to market.”
There have been greater than 31,000 fatalities from extremely potent artificial opioids in the US in 2018, the producer stories.
“Like naloxone, nalmefene is an opioid antagonist that acts by blocking the consequences of opioids on the opioid receptors,” it notes.
Nevertheless, nalmefene has an extended half-life than naloxone. These longer-acting properties could also be “of specific worth to guard towards renarcotization (second overdose), because the antagonist wears off,” in keeping with an Orexo press launch.
OX125 was developed to supply absorption of drug substances by way of the nasal mucosa.
Along with exhibiting fast absorption throughout all formulations studied, examine outcomes confirmed “good tolerability, supporting the viability” of the remedy as an opioid overdose rescue medicine, the corporate stated.
“This isn’t solely a proof-of-concept for our wholly owned OX125 product, but in addition an illustration of the worth of our novel nasal know-how platform,” Rönn stated.
“Alongside OX124, our naloxone rescue undertaking, OX125 shall be an necessary lifesaving addition in our dedication to serving to sufferers affected by opioid habit in all phases,” Sørensen added.
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