Acadia Pharma (ACAD) Commences Pimavanserin Phase 3 as Adjunctive Treatment for Schizophrenia
- Wall Street gains, helped by oil, economic data
- Twitter (TWTR) 'Takeover Money' Moves On as 'Trump Money' Moves In
- Buy Any Seasonal Market Weakness Ahead of Year End Rally - Oppenheimer (SPY)
- Unusual 11 Mid-Day Movers 12/5: (NVCN) (BCEI) (MEMP) Higher; (GTXI) (CERC) (HDSN) Lower
- Oil hits 16-month high in buying rush after OPEC agreement
Get the Pulse of the Market with StreetInsider.com's Pulse Picks. Get your Free Trial here.
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) announced the initiation of ENHANCE-1, a Phase III study to evaluate pimavanserin for adjunctive treatment of schizophrenia in patients with an inadequate response to current antipsychotic therapy. Current antipsychotics approved for schizophrenia primarily target the dopaminergic pathway. As a selective serotonin inverse agonist (SSIA), pimavanserin is a new class of antipsychotic medication with a distinct mechanism of action targeting serotonergic 5-HT2A receptors while avoiding activity at dopamine and other receptors commonly targeted by other antipsychotics.
“About 30 percent of patients with schizophrenia do not achieve an adequate response to a single antipsychotic medication, and as a result more than one in four schizophrenia patients are treated with two or more antipsychotics,” said Serge Stankovic, M.D., M.S.P.H., ACADIA’s Executive Vice President, Head of Research and Development. “We believe pimavanserin, through its highly selective mechanism of action, could provide an important new option for adjunctive treatment of schizophrenia and improve clinical outcomes by both augmenting the efficacy of currently used antipsychotics and lessening the undesirable side effects associated with polypharmacy.”
ENHANCE-1 is a Phase III, six-week, randomized, double-blind, placebo-controlled, multi-center, outpatient study designed to examine the efficacy and safety of adjunctive use of pimavanserin in patients with schizophrenia who have not achieved an adequate response to their current antipsychotic treatment. Approximately 380 patients will be randomized to receive pimavanserin, or placebo, orally, once daily, in addition to their ongoing antipsychotic in a flexible dosing regimen. The starting daily dose of 20 mg of pimavanserin at baseline may be adjusted to 34 mg or 10 mg during the first three weeks of treatment. The primary endpoint of the study is the change from baseline to week six on the Positive and Negative Syndrome Scale (PANSS) total score. Following participation in ENHANCE-1, patients will be eligible to enroll in a 52-week open-label extension study.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Juno Therapeutics (JUNO) Announces Prelim. JCAR017 Data in r/r NHL; No sCRS Observed
- Bellicum Pharma (BLCM) Announces GoCAR-T and GoTCR Preclinical Presentations ASH Meeting
- Cytori Therapeutics (CYTX) Says Review of Three-Year Follow-up Data from SCLERADEC I Trial Shows Sustained Benefit
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!