Years af­ter it was OK'd, AM­AG's drug for pre­vent­ing preterm births fails bad­ly in long-await­ed con­fir­ma­to­ry tri­al

Eight years af­ter the FDA of­fered its con­tro­ver­sial OK for a drug dubbed Mak­e­na to pre­vent preterm births, the drug­mak­er who now con­trols it says the con­fir­ma­to­ry study — be­gun a decade ago — is fi­nal­ly com­plete.

And it failed — mis­er­ably.

Waltham, MA-based AM­AG Phar­ma­ceu­ti­cals $AM­AG not­ed that the Phase II­Ib Mak­e­na tri­al was de­mand­ed by the FDA as part of an ac­cel­er­at­ed ap­proval process that set the stage for the quick roll­out of Mak­e­na, or 17p, an old drug dat­ing back to the 1950s that had been sold for just a few dol­lars a dose by com­pound­ing phar­ma­cies.

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