Acadia shares slide — again — after FDA confirms it has launched a safety review of Nuplazid

Acadia’s suffering shares $ACAD took another hit on Wednesday, plunging 22% after the FDA confirmed today that regulators have begun a review of its anti-psychosis drug Nuplazid — following CNN’s report questioning the safety of the drug.

A ’breakthrough’ drug ushered into the market to treat Parkinson’s disease psychosis, CNN recently highlighted a nonprofit’s warning on 244 deaths involving patients on the drug in less than a year after its launch. Acadia responded by saying there’s no reason to believe the drug was directly responsible for any of the deaths CNN spotlighted in its story. And the FDA noted at the time that there is no reason to believe there is any safety issue that isn’t already covered by the label. 

In a recent exchange with lawmakers, though, FDA commissioner Scott Gottlieb — who took the helm well after the drug was approved — said he would “take another look” at Nuplazid, CNN reported.

A spokesperson for the FDA confirmed to me that the drug is under review, saying:

The FDA is conducting an evaluation of available information about Nuplazid. This review has been going on for several weeks. We have nothing more to share at this time.

The attention on safety issues has pushed a steep drop in Acadia shares, which have lost more than half their value over the last 6 months.

Acadia won over an expert panel two years ago, despite a critical review by FDA insiders that clearly red-flagged their safety concerns, noting a distinct increase in the number of deaths as well as adverse events among the patients taking the drug compared to the control arm of the study — even if there was no obvious clue what was triggering those events. The agency’s approval came with a black box warning on the risks, not uncommon at the FDA.

Steve Davis, Acadia CEO

Acadia had set out to prove that the drug could also be used for Alzheimer’s disease psychosis, claiming a win in a clinical trial on the data. The results, though, quickly drew scrutiny from analysts and one Alzheimer’s expert, Lon Schneider, who noted in a subsequent review of the data that investigators had only tracked a temporary worsening in the placebo arm before claiming success. The biotech later switched strategies, though, changing to a mix of diseases associated with psychosis.

Investigators last fall described their new approach for the pivotal study, recruiting a mix of patients with Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia and frontotemporal dementia.

The added scrutiny of Nuplazid comes as the FDA has been working on accelerating the speed of drug development and agency reviews. Any issues with one of its ‘breakthrough’ drugs could conceivably slow that process down.

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Skyhawk Therapeutics Waltham, MA
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Recursion Pharmaceuticals Salt Lake City, UT

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