FDA deals out pain, hand­ing out its third pun­ish­ing slap down for opi­oid Re­moxy

Five long years af­ter the FDA re­ject­ed Re­moxy for the sec­ond time, Pain Ther­a­peu­tics has now been hand­ed its third painful FDA slap down for the sup­pos­ed­ly abuse-de­ter­rent opi­oid. This time the biotech says that it can ex­pect to take about a year for the fourth as­sault — af­ter it has a chance to re­view its op­tions and chat with reg­u­la­tors.

“The CRL fo­cus­es on the abuse-de­ter­rent prop­er­ties of Re­moxy ER and pro­posed drug la­bel­ing,” Pain said in a state­ment this morn­ing. There was no men­tion of an­oth­er study re­quire­ment.

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