Acadias Nuplazid flops schizophrenia trial on the heels of DOJ marketing probe

Acadias controversial antipsychotic med Nuplazid has faced its share of scrutiny after a safety controversy drew federal eyeballs in March. Now, the drug has to contend with a trial setback in its pursuit of a first-ever add-on approval in schizophrenia. In a phase 3 trial testing Nuplazid as an add-on to antipsychotic treatment, the drug fell short of both its goals, Acadia said Monday. Collected after six weeks of treatment, the data did show a “consistent trend” in improving psychotic symptoms over placebo in adults who did not respond to previous treatment, Acadia said. It also improved patients’ Clinical Global Severity Score, the trial’s secondary endpoint, the company said. But in both cases, the numbers fell short of statistical significance. The trial was meant to support a new indication as the first schizophrenia med approved as an add-on to patients’ current antipsychotic therapy. The slip-up puts a damper on hopes for Nuplazid, which has been churning up sales growth despite a black box warning that drew media scrutiny after the drug’s approval in 2016.