A year af­ter CRL, Aca­dia is go­ing back to bat for Nu­plazid at the FDA

A po­ten­tial block­buster drug for Aca­dia Phar­ma­ceu­ti­cals is fac­ing a new round of FDA scruti­ny in June.

The FDA is hold­ing a pub­lic ad­vi­so­ry com­mit­tee meet­ing on June 17 to dis­cuss a sup­ple­men­tal new drug ap­pli­ca­tion for Nu­plazid to treat hal­lu­ci­na­tions and delu­sions as­so­ci­at­ed with Alzheimer’s dis­ease psy­chosis.

While Nu­plazid is al­ready ap­proved for pa­tients with Parkin­son’s dis­ease psy­chosis, Aca­dia faced some hur­dles when it came to an ap­proval in pa­tients with de­men­tia-re­lat­ed psy­chosis, in­clud­ing a CRL back in 2021.

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