Acel­Rx ral­ly quick­ly fiz­zles af­ter FDA of­fers a guard­ed warn­ing about its lat­est pain drug pitch

A lit­tle less than a year af­ter the FDA kicked back Acel­Rx’s sub­lin­gual jolt of the pain med sufen­tanil, Dsu­via (ARX-04), in search of more safe­ty da­ta, in-house re­view­ers at the FDA are ready to hand it over to an out­side pan­el to get their opin­ion on its po­ten­tial.

In a cov­er memo, the FDA’s Sharon Hertz said last year’s CRL was prompt­ed by two key con­cerns: “the safe­ty of sufen­tanil sub­lin­gual tablets 30 mcg in pa­tients re­quir­ing the max­i­mum dos­ing pro­posed for la­bel­ing and the risk of mis­placed tablets.”

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