The Food and Drugs Administration is conducting a further review of Parkinson's drug, Nuplazid, over potential serious risks, but has not cited it as particularly harmful.
The initiative to evaluate Acadia's Parkinson's drug comes during the congressional budget hearing. Scott Gottlieb, the FDA commissioner, said the agency would take another look at Nuplazid amid concerns of hundreds of deaths reported by doctors and other medical professionals.
Gottlieb added that the review already began several weeks ago. The FDA did not mention specific reasons for conducting another review on Nuplazid, but only that it is based on new information on the drug's potential adverse events.
Although an evaluation is underway, the FDA is not limiting physicians to prescribe the drug or to stop patients from their current prescriptions.
"I have accumulated a great deal of experience with this drug," Dr. Joseph Jankovic, a professor of neurology at Baylor College of Medicine, told CNN. "While not all patients are completely satisfied, many of my patients have experienced marked improvement in their visual hallucinations, paranoia, and other psychotic symptoms."
Parkinson's Drug-Related Deaths
Nuplazid, with a generic name pimavanserin, is the only FDA-approved drug for the treatment of hallucinations and delusions related to Parkinson's disease psychosis.
People with a hypersensitivity reaction to pimavanserin and its components are advised not to take Nuplazid. Some of the reported side effects include peripheral edema, nausea, confusion, hallucinations, constipation, and gait disturbance.
In 2017, Nuplazid sales roughly reached $125 million as more caregivers and families had availed the drugs for its promised benefits. Dr. Paul Andreason warned that patients who took the drug during Acadia's clinical trials experienced severe adverse events including death, which is more than twice the rate in the placebo group.
Consequently, FDA called Nuplazid a "breakthrough therapy." The agency also noted the numerous pleas from patients' families and the lack of safer alternatives.
However, Dr. Andreason said he was not convinced of the FDA's ruling that the drug's benefits outweighed its risks.
Thomas Moore, senior scientist for drug safety and policy at the Institute for Safe Medication Practices, said that the related deaths are "important warning signal[s]" that warrant additional review by the authorities.
In November 2017, the ISMP published an analysis of adverse events related to Nuplazid reported within a 12-month period. Of 2,236 incidents, 244 were attributed to deaths and 333 for the ineffectiveness of the drug.
Acadia In Defense
Approximately 50 percent of Americans with Parkinson's disease experience psychosis. The Tennessee-based pharmaceutical company said that the high death rates associated with the use of Nuplazid are common among patients with advanced stage of Parkinson's.
Acadia also defended that the drug is distributed mainly in a network of specialty pharmacies, allowing them to communicate frequently with both the care providers and the patients.
In an official statement, Acadia said that mortality rates have improved since the launch of Nuplazid. They highlighted that Nuplazid underwent 25 clinical studies before it was introduced in the market. The studies involved more than 1,200 patients, 600 of which had Parkinson's disease psychosis.
"Acadia continues to vigorously monitor all adverse events through robust pharmacovigilance activities and evaluates the benefit/risk profile of Nuplazid on an ongoing basis," Acadia said in an official statement.