Acadia Pharmaceuticals is celebrating an FDA panel verdict that could set its Nuplazid drug up to be the first approved therapy for Parkinson’s disease-associated psychosis (PDP).
By a vote of 12 to 2, the advisory committee concluded that the benefits of Nuplazid (pimavanserin) outweigh its risks in PDP, setting up a possible FDA approval by the scheduled review date of 1 May.
The US regulator has already awarded Nuplazid both priority review and breakthrough status in recognition that there is a pressing need for effective therapies to control psychotic symptoms such as hallucinations and delusions in PD patients.
However, there were some anxious moments for Acadia after briefing documents released by the FDA reviewer ahead of the committee meeting questioned whether the drug’s benefits in PDP were clinically meaningful.
In particular, the agency asked for comment on the use of a new outcome measure, the Schedule for the Assessment of Positive Symptoms – Parkinson’s disease (SAPS-PD) scale, which has never before been used in a regulatory application.
Overall, the panel agreed that the benefit of the drug was modest, but concluded that this was meaningful as there is little to offer PD patients at present other than tweaking the doses of drugs used to control the motor symptoms of the disease.
In PD, dopamine agonists are used to relieve symptoms but can also trigger psychotic reactions, so getting the right dose for patients can be like walking a tightrope. Some atypical antipsychotic medicines are used to treat more advanced cases of PDP but – unlike Nuplazid – run the risk of aggravating motor symptoms.
Acadia is gearing up for a possible approval in the coming weeks and is planning to recruit around 135 sales representatives while working on an educational programme designed to raise awareness of PDP among 12,000 healthcare professionals.
The company is also working on follow-up indications for Nuplazid, including clinical programmes in Alzheimer’s disease-associated psychosis (ADP), agitation in AD patients and schizophrenia.
Analysts have indicated that they believe the drug could be a $1bn product at peak if approved in multiple indications.