A 'dis­ori­ent­ed' Pain Ther­a­peu­tics flips out af­ter FDA re­jects ap­peal on Re­moxy

Pain Ther­a­peu­tics has had the last word on its four-time re­ject Re­moxy — and it’s a bit­ter one.

Af­ter a meet­ing with the FDA, the biotech says, “we be­lieve we are no clos­er to­day to prod­uct ap­proval than we were over a year ago” thanks to “sham­bol­ic reg­u­la­tions” at the agency.

Its stock $PTIE prompt­ly fell 20%, tum­bling fur­ther in­to pen­ny­s­tock low­land.

The dis­pute here cen­ters around how eas­i­ly Re­moxy — an ex­tend­ed re­lease gel for­mu­la­tion of oxy­codone — can be abused, at a time the dead­ly opi­oid cri­sis has led to calls for height­ened vig­i­lance over ap­proval of new pain drugs.

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