Acadia was stung hard after its schizophrenia hopes for flagship Nuplazid fell flat back in late July. On the heels of that failure, Acadia is calling off a trial in dementia-related psychosis (DRP) after it saw promising interim results for the drug.
Acadia halted its phase 3 Harmony study for Nuplazid after the drug showed a significant reduction over placebo in time to relapse for patients with DRP, the drugmaker said.
The San Diego-based company said it plans to file for another FDA approval in 2020 and will submit its findings for presentation at upcoming medical meetings.
“We are very excited that today’s results bring us one step closer to the potential of offering patients with dementia-related psychosis a critically needed treatment option,” Acadia’s president Serge Stankovic said in a release.
The DRP win follows a tough stretch for Acadia after Nuplazid’s schizophrenia disappointment and ongoing scrutiny from the DOJ over the company’s marketing of the drug.
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In a separate phase 3 trial, Nuplazid as an add-on to antipsychotic treatment fell short of its primary endpoints in treating the symptoms of schizophrenia. Acadia said the trial data did show a “consistent trend” in improving psychotic symptoms over placebo in adults who did not respond to previous treatment.
Nuplazid is already approved as the first-and-only drug to treat Parkinson’s disease psychosis (PDP).
In August, Acadia CEO Steve Davis said the drugmaker had no plans to pursue the same indication in schizophrenia but would continue chasing Nuplazid indications in DRP and major depressive disorder. The drugmaker also has a separate candidate in its pipeline for Rett’s syndrome.
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The newest win could help Nuplazid add to its growing sales after the drug hauled in $83.2 million in Q2, a 46% increase over the same period in the previous year and a sign that the drug is “hitting its stride” in Parkinson’s psychosis, Davis said in August.
However, Acadia still has the specter of a DOJ probe hanging over its head.
In 2018, an FDA review of hundreds of deaths among Nuplazid patients resulted in an effective “all-clear” from the agency, which said the drug’s risks were consistent with its labeling, which includes a black-box warning for an increased risk of death in elderly patients.
In September, the DOJ subpoenaed Acadia’s records on its Nuplazid marketing, and Acadia has said it is cooperating with that request.
