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ACADIA launches mid-stage study of NUPLAZID as adjunctive therapy in patients with negative symptoms of schizophrenia

Published 11/15/2016, 11:47 AM
ACADIA launches mid-stage study of NUPLAZID as adjunctive therapy in patients with negative symptoms of schizophrenia
ACAD
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  • ACADIA Pharmaceuticals (ACAD -1.4%) initiates a Phase 2 clinical trial, ADVANCE, assessing NUPLAZID (pimavanserin) for adjunctive treatment of patients with negative symptoms of schizophrenia. There are no currently approved drugs for this population, representing as many as half of schizophrenia sufferers.
  • ADVANCE is a 26-week, double-blind, placebo-controlled study that will randomize ~380 subjects to receive either pimavanserin or placebo (once daily) in addition to their ongoing antipsychotic therapy. The starting dose of pimavanserin at baseline will be 20 mg but may be adjusted down to 10 mg or up to 34 mg during the first eight weeks of treatment. The primary endpoint is the change from baseline to week 26 in the total score of a scale called Negative Symptom Assessment-16 (NSA-16). Following the trial, participants will be eligible to enroll in a 52-week open-label extension study.
  • Schizophrenia patients are characterized by having positive or negative symptoms. Positive symptoms include hallucinations, delusions and disorganized speech. Negative symptoms include flat effect, loss of interest, emotional withdrawal and cognitive impairment.
  • NUPLAZID is a non-dopaminergic antipsychotic that acts as a selective serotonin inverse agonist that preferentially targets 5-HT2A receptors while avoiding activity at common targets like dopamine. The FDA approved it in April for the treatment of Parkinson's disease psychosis.

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