Acadia's Nuplazid flops schizophrenia trial on the heels of DOJ marketing probe

FDA
Acadia' Nuplazid flopped its phase 3 trial in schizophrenia following the launch of a DOJ probe in March. (Associated Press)

Acadia’s 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.

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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.

RELATED: FDA endorses Acadia's Nuplazid after review of deaths tied to drug

In the first quarter, Nuplazid raked in $63 million in global sales, a 29% increase over the previous year, Acadia said. Almost all of that revenue was redirected to R&D, where Acadia spent $52.9 million in the first quarter. The company's chasing Nuplazid label expansions in schizophrenia, major depressive disorder and Rett syndrome.

Those growing sales followed the FDA’s “all clear” for the drug after a CNN investigation found hundreds of reported deaths in Nuplazid patients treated for hallucinations and delusions associated with Parkinson’s disease psychosis (PDP).

After launching a post-marketing review, the FDA said its findings were consistent with a black-box warning label already affixed to the drug and found nothing “new or unexpected.”

RELATED: Justice Department launches probe into Acadia's Nuplazid marketing

Regardless of the FDA’s go-ahead, Acadia will still face federal scrutiny after the Justice Department launched a probe into the drugmaker’s Nuplazid marketing in March. In an interview at the time, Acadia CEO Steve Davis said Acadia would hand over the requested documents in keeping with the company’s “culture of compliance.”

As the first drug approved to treat PDP, Nuplazid required a robust education campaign from Acadia, Davis said, particularly because it used a different mechanism of action than other antipsychotic drugs.

“We thought there was a lot that we needed to accomplish,” he said. “We have made some very significant inroads in elevating the awareness of PDP and helping the medical community to understand some of the dynamics” in the disease.

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