A nonprofit that makes an opioid-reversal drug administered with a nasal swab submitted data to the FDA that it said showed better results than spray versions
FDA has encouraged companies to pursue nonprescription status for opioid-reversal drugs
The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of naloxone to combat the overdose crisis from bootleg fentanyl.A startup vying to produce one of the first over-the-counter overdose-reversal medications said it had submitted results to the Food and Drug Administration showing that its drug works more quickly than prescription-only versions.
The randomized trial of 60 healthy volunteers evaluated naloxone absorption from Pocket Naloxone Corp.’s nasal swab versus a 4 milligram nasal-spray delivery and found 74% higher exposure 2.5 minutes after dosing and 19% higher exposure at 5 minutes. Naloxone works by blocking the effects of opioids.
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