ACADIA Pharmaceuticals Announces NUPLAZID™ (pimavanserin) Is Now Available for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis

NUPLAZID is the First and Only FDA-Approved Drug for this Indication

An Estimated 40 Percent of Parkinson’s Disease Patients Have Psychosis

SAN DIEGO–(BUSINESS WIRE)–May 31, 2016– ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that NUPLAZID™ (pimavanserin) is now available for prescription in the United States. NUPLAZID was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

NUPLAZID is the first and only drug approved by the FDA for this indication. NUPLAZID is also the only drug approved by the FDA that preferentially targets 5-HT2A receptors. These receptors are thought to play an important role in Parkinson’s disease psychosis. The unique pharmacology of NUPLAZID establishes a new class of drug – selective serotonin inverse agonists (SSIA) – by not only preferentially targeting 5-HT2A receptors but also avoiding activity at dopamine and other receptors commonly targeted by antipsychotics. Typical Parkinson’s disease therapy consists of drugs that stimulate dopamine to treat patients’ motor symptoms such as tremor, muscle rigidity and difficulty with walking. NUPLAZID does not interfere with patients’ dopaminergic therapy and therefore does not impair their motor function.

“I am delighted that we now have an effective and FDA-approved therapy for patients with hallucinations and delusions associated with Parkinson’s disease psychosis,” said Neal Hermanowicz, M.D., Health Sciences Clinical Professor, Neurology, UC Irvine School of Medicine and Director, UC Irvine Movement Disorders Program. “In the pivotal Phase III study of NUPLAZID, we observed significant reductions in the severity and frequency of hallucinations and delusions in patients with Parkinson’s disease psychosis. Importantly, these benefits were achieved without impairing motor function.”

According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. An estimated 40 percent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions, is associated with significant caregiver burden, and is a major reason for nursing home placement among Parkinson’s patients.

“We believe NUPLAZID fills an important therapeutic gap as the first FDA-approved treatment for patients afflicted with hallucinations and delusions associated with Parkinson’s disease psychosis,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “We are excited to bring this new treatment option to patients living with the challenges of this debilitating condition.”

NUPLAZIDconnect™ Patient Access and Support Services

ACADIA is committed to ensuring that patients in the United States who are prescribed NUPLAZID are able to access the medicine and receive the ongoing support they may need. ACADIA has established NUPLAZIDconnect™, a comprehensive program that provides access assistance to patients, their caregivers, and physicians, as well as financial assistance to those patients who qualify. NUPLAZID is available through a specialty pharmacy network. Patients and physicians can access information about NUPLAZID and NUPLAZIDconnect by visiting www.nuplazid.com or calling 844-737-2223.

About NUPLAZID™ (pimavanserin)
NUPLAZID is the first FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. NUPLAZID is a non-dopaminergic, selective serotonin inverse agonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson’s disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg (two 17 mg tablets). ACADIA discovered this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID. Please see full prescribing information at www.nuplazid.com. For additional information and multimedia assets on NUPLAZID, click here http://www.businesswire.com/news/home/20160429006144/en/

Important Safety Information and Indication for NUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.

NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.

Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half.

Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.

Pediatric Use: Safety and efficacy have not been established in pediatric patients.

Dosage and Administration: Recommended dose: 34 mg per day, taken orally as two 17 mg tablets once daily, without titration.

About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA maintains a website at www.acadia-pharm.com to which we regularly post copies of our press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.

Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the benefits to be derived from ACADIA’s product candidates and from NUPLAZID (pimavanserin); whether NUPLAZID fills an important therapeutic gap as the first FDA-approved treatment for patients afflicted with hallucinations and delusions associated with Parkinson’s disease psychosis; whether NUPLAZID establishes a new class of drug; whether ACADIA will be able to ensure patients have access to NUPLAZID; and the assistance that will be available to patients, their caregivers and physicians from ACADIA, including through NUPLAZIDconnect. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development, and commercialization, whether NUPLAZID receives adequate reimbursement from third-party payers, ACADIA’s ability to establish an adequate specialty pharmacy network to distribute NUPLAZID, the degree to which NUPLAZID receives acceptance from patients and physicians for its approved indication, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA’s annual report on Form 10-K for the year ended December 31, 2015 as well as ACADIA’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

Source: ACADIA Pharmaceuticals Inc.