An old, con­tro­ver­sial Pfiz­er drug shows mid-stage ef­fi­ca­cy against nar­colep­sy

Re­box­e­tine nev­er got much trac­tion in the US. Mar­ket­ed as an an­ti-de­pres­sant in Eu­rope for the past 20 years, the Pfiz­er drug was pro­vi­sion­al­ly FDA-ap­proved in 1999 but the agency lat­er re­tract­ed their per­mis­sion and, more re­cent­ly, a Ger­man meta-analy­sis made the com­pound a prime ex­am­ple of trans­la­tion­al fail­ure. “In­ef­fec­tive and po­ten­tial­ly harm­ful,” the analy­sis con­clud­ed.

Last Oc­to­ber, though, a small New York-based CNS biotech called Ax­some an­nounced it would try to res­ur­rect the com­pound, which has al­ways worked el­e­gant­ly in mice, state­side to treat nar­colep­sy. Yes­ter­day, they un­veiled Phase II da­ta show­ing the drug may in­deed help pre­vent cat­a­plexy at­tacks and re­duce day­time sleepi­ness, two of the dis­or­der’s pri­ma­ry symp­toms.

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