Should Nar­can spray be sold over the counter? FDA pos­es po­ten­tial pack­ag­ing changes

Two of the FDA’s ad­vi­so­ry com­mit­tees are meet­ing on Wednes­day to dis­cuss whether the av­er­age con­sumer can use Emer­gent BioSo­lu­tions’ opi­oid over­dose drug Nar­can cor­rect­ly with­out train­ing or a pre­scrip­tion — and the agency has a few sug­ges­tions on the po­ten­tial pack­ag­ing, ac­cord­ing to brief­ing doc­u­ments.

Use of nalox­one has sky­rock­et­ed since 2017, in­creas­ing from 359,000 pre­scrip­tions dis­pensed that year to 1.5 mil­lion pre­scrip­tions in 2021, main­ly due to a boost in nasal spray for­mu­la­tions, reg­u­la­tors wrote in brief­ing doc­u­ments. Emer­gent filed a sup­ple­men­tal ap­pli­ca­tion to take its Nar­can nasal spray over the counter last year, and reg­u­la­tors have said they ex­pect a de­ci­sion on March 29.

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