Dive Brief:
- A postmarketing review by the Food and Drug Administration of Acadia Pharmaceuticals' Parkinson's disease drug Nuplazid turned up no new safety findings, sending shares of the biotech up more than 26% Thursday.
- After analyzing all available data on deaths and serious adverse events associated with Nuplazid, the FDA concluded the drug's benefits still outweighed its risks in treating patients with Parkinson's disease psychosis.
- Nuplazid's safety had been a concern before, and a recent investigation by CNN spurred new worries. The drug carries a boxed warning for an increased risk of death associated with antipsychotic use in elderly patients with dementia-related psychosis. The FDA said it will continue to monitor adverse event reports.
Dive Insight:
There has been wariness around Nuplazid (pimavanserin) for some time.
When it reached an FDA advisory committee in March 2016, the drug had spent about a decade in clinical development. Testing had shown positive efficacy but also some safety risks.
The advisory committee voted 12-2 in concluding Nuplazid's benefits outweighed its risks in patients with hallucinations and delusions tied to Parkinson's disease psychosis. The drug was approved in May of 2016 with its current black box warning.
Antipsychotics are linked with an increased risk of death in elderly patients. However, in its review of Nuplazid in patients with Parkinson’s disease psychosis, the FDA associated this higher mortality rate to older age, advanced Parkinson’s disease, and other medical conditions.
The agency concluded that "there was no evident pattern to suggest a drug effect" in safety reports for Nuplazid which included a cause of death.
As Nuplazid is largely distributed through a patient support program and a specialty pharmacy network, this may also increase the likelihood that deaths will be reported to the company, the FDA said.
However, the regulator's statement did include a notable caveat. Many of the reports the FDA assessed "did not provide sufficient information to assess drug cause and effect."
The FDA also raised concerns about prescribing patterns, such as the concomitant use of Nuplazid along with other antipsychotics or drugs that cause QT prolongation, a potential cause of heart rhythm disorder.
Nuplazid increases the chance of QT prolongation and serious arrhythmia, so the FDA has warned health care providers to be be careful of using Nuplazid with drugs that have a similar risk.
For Acadia, the review removes the risk for now that the FDA could have uncovered a new safety concern with the drug.
“Nothing is more important to Acadia than the wellbeing of the patients who use Nuplazid," said company CEO Steve Davis in a statement. "We are very pleased with the FDA's clear statement reaffirming Nuplazid's positive benefit-risk profile.”
Nuplazid is also in Phase 3 development for dementia-related psychosis and Phase 2 testing as an adjunctive therapy in schizophrenia and major depressive disorder.