Pre­sent­ed with up­beat Alzheimer's ag­i­ta­tion da­ta, FDA sees an­oth­er 'break­through' in Ax­some's AXS-05

Ax­some Ther­a­peu­tics’ sur­prise win in a late-stage Alzheimer’s study, un­veiled just two months ago, has reg­is­tered with reg­u­la­tors. The New York-based biotech has notched a break­through ther­a­py des­ig­na­tion for AXS-05 for the in­di­ca­tion, its sec­ond af­ter ma­jor de­pres­sive dis­or­der.

So what’s the big deal here? The drug is an oral agent “with mul­ti­modal ac­tiv­i­ty” con­sist­ing of two com­po­nents: dex­tromethor­phan, an NM­DA re­cep­tor an­tag­o­nist, and bupro­pi­on — whose main pur­pose is to slow down the me­tab­o­lism of the for­mer.

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