No­var­tis part­ner Durect reg­is­ters a PhI­II pain drug flop, biotech’s shares crater

Eigh­teen months af­ter the FDA or­dered Durect$DR­RX to amend its Phase III study of its pain drug posimir, the biotech is re­port­ing that the ther­a­py flopped — and the pro­to­col change may have played a key role in the fail­ure.

The agency de­mand­ed that Durect add bupi­va­caine as a com­para­tor drug in the Phase III tri­al of its ex­tend­ed-re­lease ver­sion of the drug. On­ly the top-line demon­strat­ed that there was no sta­tis­ti­cal dif­fer­ence in pa­tient re­sponse for the end­point: Re­duc­tion in pain on move­ment in the first 48 hours af­ter surgery.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA