Still in spot­light of a fed­er­al probe, In­sys touts PhI­II pain study as it preps an NDA

Still in the spot­light for fed­er­al in­ves­ti­ga­tions sur­round­ing sev­er­al cas­es of off-la­bel mar­ket­ing, In­sys Ther­a­peu­tics $IN­SY says it has come up with promis­ing Phase III da­ta for its most ad­vanced spray for­mu­la­tion of an ag­ing drug.

The drug is Buprenor­phine Sub­lin­gual Spray, a new for­mu­la­tion for an ad­dic­tion drug that is be­ing re­pur­posed to treat pain. Phoenix-based In­sys says that they hit the pri­ma­ry end­point in the study, test­ing three dos­es against a place­bo for mod­er­ate to se­vere post­op­er­a­tive pain af­ter a “bunionec­to­my.” The state­ment did not in­clude any da­ta, though. Now the com­pa­ny wants to start mov­ing to­ward a new drug ap­pli­ca­tion.

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