A naloxone nasal spray should be sold over-the-counter, a panel of the Food and Drug Administration's outside advisers unanimously voted Wednesday, clearing the way for the regulator to broaden access to reversing drug overdoses.
– initial steps typically left up to drugmakers to pay for – in hopes of encouraging manufacturers to pursue selling naloxone over-the-counter.
However, FDA officials told the panel that they had identified a handful of shortcomings with the company's study. And despitethat may have biased the study towards positive results, the regulator noted there were still errors using the spray. Some users started on the wrong steps or administered the spray incorrectly.
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