Heron's pain drug nails PhI­II, prep­ping the com­pa­ny for NDA lat­er this year

San Diego’s Heron Ther­a­peu­tics $HRTX is on a roll, to­day trum­pet­ing good news from its Phase III tri­al in post-op­er­a­tive pain. The promis­ing da­ta will back the drug­mak­er’s bid for FDA ap­proval of the drug lat­er this year. If ap­proved, it would be the sec­ond FDA OK for Heron in a mat­ter of months.

The news is send­ing Heron’s stock price soar­ing, up near­ly 26% since the an­nounce­ment.

The com­pa­ny’s pain drug is a long-act­ing lo­cal anes­thet­ic made up of bupi­va­caine and meloxi­cam, which Heron calls HTX-011. The drug was test­ed in two Phase III stud­ies that mea­sured post-surgery pain and opi­oid use af­ter bunionec­to­my (bunion re­moval) and her­nia re­pair. HTX-011 achieved all its pri­ma­ry and sec­ondary end­points in both tri­als, ac­cord­ing to Heron.

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