Tuesday, May 24, 2016

New Drug for the Treatment of Parkinson's Psychosis


As a former FDA employee in the Center of New Drugs and a primary caretaker for a love one with Parkinson, the above news attracted my attention. The new drug is Nuplazid or Pimavanserin manufactured by Acadia Pharmaceuticals, Inc.

Pimavanserin was approved by the FDA just recently specifically for the treatment of Parkinson's disease psychosis.
It works in a different way than other antipsychotics: it does not block dopamine. It is a selective serotonin inverse agonist, meaning it targets serotonin receptors. This makes it a safer choice when treating people with PD that are experiencing psychoses, because it can reduce hallucinations without affecting motor performance.

NUPLAZID™ (pimavanserin) is the first and only medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

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, a debilitating condition that 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.

The following information is from the insert published by Acadia Pharmaceuticals, Inc.:

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.

INDICATIONS AND USAGE
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. For details on the balancing act of treatment between motor symptoms and psychosis read the following: http://www.parkinson.org/understanding-parkinsons/non-motor-symptoms/Psychosis/What-are-the-Treatment-Options-for-Psychosis

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