Media reports over Parkinson’s drug risk hit Acadia hard

pharmafile | April 10, 2018 | News story | Manufacturing and Production, Medical Communications Acadia Pharmaceutical, biotech, drugs, pharma, pharmaceutical 

Shortly after the Institute for Safe Medication Practices released a report revealing the number of deaths of patients in those taking Acadia Pharmaceuticals’ Nuplazid, the biotech’s shares tanked – dropping from $35 to $27 in just a few weeks.

Since the report was released, the biotech’s stock never fully recovered and then CNN released a story on the risks associated with the drug, leading to another massive drop of 23% in share price. It now sits at $16, less than half the value from when the initial report was first published.

It’s understandable why this coverage would hit the biotech so hard, Nuplazid is its only marketable product and it hopes to expand its indication into four other indication, including schizophrenia treatment and major depressive disorder.

The drug is currently approved to treat hallucinations and delusions associated with Parkinson’s disease psychosis. It is the only product on the market to treat this condition and expected the drug to reap sales of $270 million this year alone, after managing $125 million in 2017.

However, those sales figures could be hit, after CNN highlighted that there had been 244 deaths reported to the FDA between the drug’s launch in June 2016 and March 2017 that were related to patients’ use of Nuplazid.

The FDA’s committee voted to approve the drug with a vote of 12-2, though this came with the awareness that there were risks associated with the drug – on balance, it was considered that the risk-benefit ratio of the drug, especially given the poor health of patients likely to receive it, meant it was worth giving families of patients the option of the drug.

The drug comes with the strongest warning possible for an approved treatment, with a black box warning detailing the risks and potential increase in the risk of death for those receiving it.

However, FDA data now shows that the number of deaths where the drug is suspected as being associated has risen to at least 500 and pressure on the biotech will only increase as this figure goes up.

In its own defence, the company released a statement on its own monitoring of the safety of the drug: “As part of our standard pharmacovigilance efforts, Acadia continues to regularly monitor and evaluate mortality risks for Nuplazid, and we report this quarterly to the FDA in the Periodic Adverse Drug Experience Report. Since launch, Nuplazid overall mortality rate is 14.4 per 100 patient years. It’s important to note that this is lower than overall mortality rate for PDP patients in the Medicare Claims Database (2012-2015) of 2.2 per 100 patient years.”

This bullishness on the benefits that its medication brings is confirmed by the FDA, which suggested that the data provided to it, on patient deaths, do not highlight a specific safety issue that it had not already included on the label of the product.

It means little will likely change on marketing authorisation of the product, but it could see physicians being much warier of recommending the drug to families – hitting Acadia where it hurts, in sales.

Ben Hargreaves

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