The FDA is digging back into the safety numbers on Acadia Pharmaceuticals' antipsychotic drug Nuplazid after reports of side effects—including deaths—raised questions about its approval two years ago.
"The FDA is conducting an evaluation of available information about Nuplazid," an agency spokesperson told FiercePharma via email. "This review has been going on for several weeks. We have nothing more to share at this time."
The confirmation comes amid a surge of criticism for Nuplazid, prompted in part by a CNN report in early April that said hundreds of patients died after receiving the drug for Parkinson's-related psychosis. FDA Commissioner Scott Gottlieb told lawmakers this week he'd "take another look" at Nuplazid after they grilled him about the drug's safety at a hearing on Capitol Hill.
It's not the first time Acadia has faced questions about Nuplazid's safety. A November analysis by the Institute for Safe Medication Practices documented 244 deaths between Nuplazid's launch in June 2016 and March 2017. All told, the FDA has tracked more than 700 deaths after patients received the drug. And before it was approved, the agency's staff reviewers noted their own worries about its risks.
Acadia said it stands by the safety of its med, which was approved in April 2016 with a black-box warning.
"As the only drug currently approved by the FDA for the treatment of hallucinations and delusions associated with [Parkinson’s disease psychosis], Nuplazid is filling an important and previously unmet need and offers hope to those with PDP and the people who care for them," the company said in a statement posted on its website. "We remain confident in the efficacy and safety of Nuplazid that supported its approval by the FDA and stand firmly behind it."
Parkinson's disease psychosis causes patients to experience hallucinations and delusions, and about half of Parkinson's patients develop the symptoms, according to the American Parkinson Disease Association. About 90% of Parkinson's cases are in people 50 or older, according to the organization.
At Nuplazid's panel review in 2016, experts voiced some concerns about the drug's data, but many said Nuplazid would treat patients with no alternatives—patients who'd be willing to take the risks associated with the therapy. For their part, the FDA's own reviewers raised questions about safety and efficacy ahead of the meeting.
Still, the FDA blessed the med in April 2016, and Nuplazid hit the market in June of that year.
The FDA's decision to sift through the data appears to be a reversal, judging from a recent statement the agency issued to the press. After the original CNN report, an FDA representative told The San Diego Union-Tribune that the agency hadn't "identified a specific safety issue that is not already adequately described in the product labeling."
In a note following that April 9 CNN story, Evercore ISI analyst Josh Schimmer wrote that the CNN report was based on a "completely uncontrolled analysis of patient deaths." Still, the publication's reporting spooked investors, as share prices fell about 20% on the initial news. Now that the FDA has taken up a review, share prices fell another 23% on Wednesday.