Emergent BioSolutions Inc's over-the-counter version of opioid overdose reversing drug received unanimous support from U.S. Food and Drug Administration's panel of advisers, sending shares of the contract drugmaker up nearly 16% after market.
Advisers suggested that all five steps of administering the drug should be printed only on the back panel instead of across the back and side panels of the drug's packaging, which has led to confusion among consumers about the order of the steps to be followed.
"The current prescription version has a little paper flap that gives the instructions..which the proposed over-the-counter version won't have. It would just be very clear on the box about the steps to use and so I think that would be helpful," said Scott Weiner, an emergency medicine physician at Brigham and Women's Hospital ahead of the panel meeting.
In support of the favorable vote, the American Medical Association said it believes "greater access will occur when naloxone for overdose risk is just as easily accessible in a pharmacy, grocery store and other common locations as a decongestant for a stuffy nose."
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FDA panel weighs moving opioid antidote over the counterU.S. health advisers are weighing whether the overdose-reversal drug naloxone, commonly referred to as Narcan, should be made available as an over-the-counter medication.
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