Aca­dia hits an­oth­er Nu­plazid road­block as the FDA doles out CRL and rec­om­mends an­oth­er tri­al

De­spite win­ning an ap­proval back in 2016, Aca­dia’s Nu­plazid has not had the eas­i­est of paths in its jour­ney to ex­pand in­to new ar­eas. And late Thurs­day night, the com­pa­ny put out a press re­lease say­ing it re­ceived more bad news from the FDA.

Reg­u­la­tors re­ject­ed Aca­dia’s ap­pli­ca­tion to ex­pand Nu­plazid cov­er­age in­to Alzheimer’s-re­lat­ed psy­chosis, the biotech said, turn­ing away its sup­ple­men­tal NDA with a CRL. The re­jec­tion let­ter in­di­cat­ed the FDA al­so rec­om­mend­ed that Aca­dia con­duct an ad­di­tion­al tri­al in ADP, Aca­dia said.

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