Concludes
Acadia Pharmaceuticals’ drug provides ‘modest but meaningful’ benefits
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).
 |
| Nuplazid |
March 30, 2016
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
http://health.einnews.com/article/318974815/WrgBAbuZpeaFrreS
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