Nuplazid (pimavanserin) is an atypical antipsychotic which is approved for the treatment of Parkinson’s disease psychosis and is also being researched for the treatment of Alzheimer’s disease psychosis, schizophrenia, agitation, and major depressive disorder. Unlike other antipsychotics, it is not a dopamine receptor antagonist. Developed by Acadia Pharmaceuticals, it was approved by the FDA in 2014.
Could trouble be brewing? Seeking Alpha reported in late 2018 that Nuplazid is its key revenue driver in 2018 and 2019. More on the financials of Acadia but first on to a far more important topic—patient safety. Jonathan Block, writing for MedShadow, reports that since June 2016, the FDA has received more than 700 reports of Nuplazid-related deaths. There are calls to pull the drug immediately from the market. We agree. This is a dangerously high number.
As new drugs are approved under the expedited or accelerated approval pathway the FDA has a responsibility to be every vigilant in monitoring safety signals very carefully. For whatever reason, Block notes, the FDA has taken their eye off the ball here. After all, that is why Congress created the law that was the genesis for the agency—patient safety.
The drug was assigned “breakthrough therapy designation” due to the fact that in clinical trials it evidenced significant improvements over other drugs. Moreover it was the only such approved drug, as Block reminds the reader, to treat hallucinations and delusions associated with Parkinson’s psychosis.
Back in 2017 it was already becoming apparent there were potential problems. The Institute for Safe Medication Practices (ISMP) reported in its QuarterWatch report that Nuplazid was associated with 2,236 adverse events. Of great concern: 11% of the Nuplazid reports involved death. Nuplazid does carry a “black box” warning as Block notes and involves death. As of April, 700 have died that were also taking Nuplazid. CNN reported that the FDA is undertaking a new Nuplazid study.
Medshadow author Block believes the drug should be pulled—and while all are waiting the FDA should strengthen the label to reflect the dangerous observations on the market.
Acadia Pharmaceuticals could find itself in trouble. According to Yahoo Finance its’ EBITDA forecast is a loss of -$244 million. Although it is publicly traded and has $473 million in the bank, it burns through nearly $200 million per annum. Its valuation at $27.32 per share equals $3.9 billion (high multiple on no profits); this high multiple could be in jeopardy should the FDA act and take the drug off the market.