A drug that could change the way Parkinson's disease is treated just got closer to approval

March 29, 2016

A human neuron.

A new drug that aims to treat a serious symptom of Parkinson's disease just won a critical endorsement from a Food and Drug Administration advisory committee.

The drug, called Nuplazid, is being developed by Acadia Pharmaceuticals. It is designed to treat psychosis, a symptom of Parkinson's that can involve hallucinations and delusions.

Parkinson's disease is a neurodegenerative disorder characterized by motor symptoms such as shaking in the hands and legs, as well as stiffness and impaired balance. 

But up to 40% of people are estimated to experience psychosis symptoms as well. 

Right now, there are no approved treatments specifically for Parkinson's disease psychosis, or PDP, and clinical trials looking at the use of traditional antipsychotics to treat PDP suggest that they're not particularly effective.

The FDA still has to vote to approve the drug, a decision that is ultimately independent of the committee's decision. That decision is expected to arrive by May 1.

Bank of America Merrill Lynch said in a note Monday that it expected the FDA panel to vote to recommend Nuplazid for PDP, because it doesn't interfere with other Parkinson's medications and there is no other approved treatment. Analysts estimate at least a $1 billion market for the drug. 

Shares of Acadia were halted Tuesday, because of the advisory committee's decision.

The advisory committee focused on data from a late-stage, six-week clinical trial of Nuplazid in 199 patients, which suggested that the drug may benefit those with PDP. Of the 199, about half were given Nuplazid in addition to any other Parkinson's treatment they were currently using, while the other were given a placebo. None of the participants were allowed to take any other form of antipsychotic.

Ten participants had to end the trial early because of adverse events, and four of those were on Nuplazid.

From there, and based off earlier trial results, they had to determine whether the drug was effective, safe, and whether the overall benefit of the drug's effects outweigh any risks associated with the drug. On the first question, the panel voted 12-2, the safety question 11-3, and the benefit-risk question 12-2.

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