FDA dis­miss­es Alk­er­mes’ pitch on ‘5461, de­mand­ing new de­pres­sion tri­als in a dam­ag­ing set­back

Alk­er­mes $ALKS made a high-stakes gam­ble that the FDA would con­sid­er ap­prov­ing their big de­pres­sion drug ALKS-5461 on the ba­sis of a sin­gle pos­i­tive Phase III study — and they lost. The biotech re­port­ed Mon­day morn­ing that the agency had is­sued a refuse-to-file let­ter for the drug, se­ri­ous­ly de­lay­ing any shot at an OK.

Ac­cord­ing to the com­pa­ny state­ment, the FDA is de­mand­ing more clin­i­cal tri­als to pro­vide a full set of da­ta as well as a “bioavail­abil­i­ty study to gen­er­ate ad­di­tion­al bridg­ing da­ta be­tween ALKS 5461 and the ref­er­ence list­ed drug, buprenor­phine.”

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