Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a cou­ple of ma­jor reg­u­la­to­ry mile­stones for its new drug, Arde­lyx has bagged an FDA ap­proval to mar­ket Ib­srela (tena­panor) for ir­ri­ta­ble bow­el syn­drome.

The drug’s first ap­pli­ca­tion will be for IBS with con­sti­pa­tion (IBS-C), in­hibit­ing sodi­um-hy­dro­gen ex­chang­er NHE3 in the GI tract in such a way as to in­crease bow­el move­ments and de­crease ab­dom­i­nal pain. This comes on the heels of two suc­cess­ful Phase III tri­als.

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