Acadia readies new round of Nuplazid DTC as federal marketing probe continues

With a trial flop for its Nuplazid in adjunct schizophrenia still stinging and a federal probe into the drug’s marketing ongoing, Acadia is hoping a new round of TV ads will help court more patients.

The campaign’s goal? Helping Parkinson’s disease psychosis (PDP) patients have the “right conversation” with their physicians.

Acadia will roll its second DTC television campaign in the back half of 2019 in an effort to “try to close that information gap so that patients have a greater awareness” of Nuplazid as a treatment for PDP, CEO Steve Davis said. Nuplazid was the first drug approved by the FDA to treat PDP but faced a review from the agency last year after hundreds of patients died while taking the drug.

Davis said most of Acadia’s marketing efforts centered on combating the “information gap” for PDP, a condition he says is often underdiagnosed and misunderstood by both patients and physicians.

When a patient is first diagnosed with Parkinson's, "most physicians don’t tell you you could start having delusions and hallucinations,” Davis said. “(Patients) don’t connect the dots, and they don’t realize it’s a symptom of Parkinson’s disease.”

RELATED: Acadia debuts first Nuplazid branded ads, aiming to spark talk of Parkinson's psychosis

While Davis admitted Nuplazid has a long way to go to cover that gap, he said the newest rounds of TV ads would be in the same vein as the last, which rolled out around Thanksgiving 2018 and ended in the spring. The branded Nuplazid campaign followed a PDP awareness campaign that stretched from fall 2017 to spring 2018.

Davis said the new ads would look “very similar” to those from the last campaign and called those spots “still fresh and resonant.”

As the first drug approved to treat PDP, Nuplazid has faced a raft of scrutiny in its first three years on the market, as well as a recent setback in pursuing an adjunct schizophrenia label expansion.

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

Late last month, Acadia said the drug had not hit its primary endpoints in reducing the symptoms of schizophrenia over placebo as a follow-up treatment for patients who did not respond to previous standard-of-care regimens. Nuplazid did show a “consistent trend” of reducing symptoms after six weeks, Acadia said, but not to a significant degree.

Following the trial flop, Acadia has no intention of pursuing that particular schizophrenia indication again, Davis said, but it does have another phase 3 trial investigating Nuplazid as an adjunct treatment for patients who do respond to standard-of-care therapy. The drugmaker is also pursuing indications in dementia-related psychosis and major depressive disorder and is has a drug prospect in its pipeline for Rett’s syndrome.

In PDP alone, Nuplazid raked in $83.2 million in Q2 sales, a 46% increase over the same period in the previous year and a sign that the drug is “hitting its stride” in that indication, Davis said.

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

However, Acadia still faces a Department of Justice probe into its Nuplazid marketing. In September, the DOJ subpoenaed Acadia’s records on its Nuplazid marketing, following up on an “all-clear” the drugmaker received from the FDA, which said the drug's risks were consistent with its labeling.

Acadia had no update on the probe last week, but Davis said the drugmaker was fully cooperating with the DOJ’s request.

Editor's Note: This story has been updated to correct details of Acadia's pharmaceutical pipeline and clarify a comment from CEO Steve Davis.