In a new set­back, FDA kicks back Acel­Rx’s ap­pli­ca­tion for pain med — shares tank again

An ac­ci­dent-prone Acel­Rx $ACRX has stum­bled in­to an­oth­er reg­u­la­to­ry ditch.

The biotech re­port­ed this morn­ing that the FDA re­ject­ed its ap­pli­ca­tion for Dsu­via (ARX-04), a sub­lin­gual jolt of the pain med sufen­tanil. Ac­cord­ing to the state­ment, the FDA wants more safe­ty da­ta on at least 50 pa­tients while al­so de­mand­ing a hu­man fac­tors study to val­i­date the changes made on di­rec­tions for use.

That’s all quite man­age­able, says the com­pa­ny. But af­ter some ear­li­er mis­steps, in­clud­ing reneg­ing on a promise that the agency would not re­quire a new late-stage study of its lead opi­oid pain drug Za­lvi­so a cou­ple of years ago, Acel­Rx has de­vel­oped some­thing of a cred­i­bil­i­ty prob­lem with in­vestors.

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