Neu­ro­crine steers its ‘break­through’ tar­dive dysk­i­ne­sia drug to an FDA de­ci­sion

San Diego-based Neu­ro­crine Bio­sciences an­nounced that it has filed their NDA on a new drug for tar­dive dysk­i­ne­sia to­day, but the com­pa­ny isn’t wait­ing for the FDA to make up its mind be­fore lay­ing the ground­work on a mar­ket­ing cam­paign.

Com­pa­ny ex­ecs not­ed in their Q2 call with an­a­lysts that they are al­ready build­ing a mar­ket­ing group for the drug, val­be­nazine, which has achieved a break­through drug des­ig­na­tion that could put it on track to an ap­proval as ear­ly as next spring. The drug is a VMAT2 in­hibitor, de­signed to mod­u­late dopamine re­lease dur­ing nerve com­mu­ni­ca­tion. And it’s al­so in Phase II for Tourette syn­drome.

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