pimavanserin
Generic: PIMAVANSERIN
Basic Information
Manufacturer
Novadoz Pharmaceuticals LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
403b6540-c53d-4e92-91b4-36ca6338b2b1
Indications & Usage
1 INDICATIONS AND USAGE Pimavanserin capsule is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis [see Clinical Studies (14) ].
Pimavanserin capsule is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
(1)
Pimavanserin capsule is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
(1)
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] QT Interval Prolongation [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥5% and twice the rate of placebo): peripheral edema and confusional state.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical trial database for pimavanserin consists of over 1200 subjects and patients exposed to one or more doses of pimavanserin.
Of these, 616 were patients with hallucinations and delusions associated with Parkinson’s disease psychosis (PDP).
In the placebo-controlled setting, the majority of experience in patients comes from studies evaluating once-daily pimavanserin doses of 34 mg (N=202) compared to placebo (N=231) for up to 6 weeks.
In the controlled trial setting, the study population was approximately 64% male and 91% Caucasian, and the mean age was about 71 years at study entry.
Additional clinical trial experience in patients with hallucinations and delusions associated with PDP comes from two open-label, safety extension studies (total N=497).
The majority of patients receiving long-term treatment received 34 mg once-daily (N=459).
Over 300 patients have been treated for more than 6 months; over 270 have been treated for at least 12 months; and over 150 have been treated for at least 24 months.
The following adverse reactions are based on the 6-week, placebo-controlled studies in which pimavanserin was administered once daily to patients with hallucinations and delusions associated with PDP.
Common Adverse Reactions (incidence ≥5% and at least twice the rate of placebo): peripheral edema (7% pimavanserin 34 mg vs.
2% placebo) and confusional state (6% pimavanserin 34 mg vs.
3% placebo).
Adverse Reactions Leading to Discontinuation of Treatment A total of 8% (16/202) of pimavanserin 34 mg-treated patients and 4% (10/231) of placebo-treated patients discontinued because of adverse reactions.
The adverse reactions that occurred in more than one patient and with an incidence at least twice that of placebo were hallucination (2% pimavanserin vs.
<1% placebo), urinary tract infection (1% pimavanserin vs.
<1% placebo), and fatigue (1% pimavanserin vs.
0% placebo).
Adverse reactions that occurred in 6-week, placebo-controlled studies and that were reported at an incidence of ≥2% and >placebo are presented in Table 1 .
Table 1 Adverse Reactions in Placebo-Controlled Studies of 6-Week Treatment Duration and Reported in ≥2% and >Placebo Percentage of Patients Reporting Adverse Reaction Pimavanserin 34 mg Placebo N=202 N=231 Gastrointestinal disorders Nausea 7% 4% Constipation 4% 3% General disorders Peripheral edema 7% 2% Gait disturbance 2% <1% Psychiatric disorders Hallucination 5% 3% Confusional state 6% 3% Adverse Reactions in Demographic Subgroups Examination of population subgroups in the 6-week, placebo-controlled studies did not reveal any differences in safety on the basis of age (≤75 vs.
>75 years) or sex.
Because the study population was predominantly Caucasian (91%; consistent with reported demographics for PD/PDP), racial or ethnic differences in the safety profile of pimavanserin could not be assessed.
In addition, in the 6-week, placebo-controlled studies, no clinically relevant differences in the incidence of adverse reactions were observed among those with a Mini-Mental State Examination (MMSE) score at entry of <25 versus those with scores ≥25.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of pimavanserin.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These reactions include rash, urticaria, reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea), somnolence, falls, agitation and aggression.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical trial database for pimavanserin consists of over 1200 subjects and patients exposed to one or more doses of pimavanserin.
Of these, 616 were patients with hallucinations and delusions associated with Parkinson’s disease psychosis (PDP).
In the placebo-controlled setting, the majority of experience in patients comes from studies evaluating once-daily pimavanserin doses of 34 mg (N=202) compared to placebo (N=231) for up to 6 weeks.
In the controlled trial setting, the study population was approximately 64% male and 91% Caucasian, and the mean age was about 71 years at study entry.
Additional clinical trial experience in patients with hallucinations and delusions associated with PDP comes from two open-label, safety extension studies (total N=497).
The majority of patients receiving long-term treatment received 34 mg once-daily (N=459).
Over 300 patients have been treated for more than 6 months; over 270 have been treated for at least 12 months; and over 150 have been treated for at least 24 months.
The following adverse reactions are based on the 6-week, placebo-controlled studies in which pimavanserin was administered once daily to patients with hallucinations and delusions associated with PDP.
Common Adverse Reactions (incidence ≥5% and at least twice the rate of placebo): peripheral edema (7% pimavanserin 34 mg vs.
2% placebo) and confusional state (6% pimavanserin 34 mg vs.
3% placebo).
Adverse Reactions Leading to Discontinuation of Treatment A total of 8% (16/202) of pimavanserin 34 mg-treated patients and 4% (10/231) of placebo-treated patients discontinued because of adverse reactions.
The adverse reactions that occurred in more than one patient and with an incidence at least twice that of placebo were hallucination (2% pimavanserin vs.
<1% placebo), urinary tract infection (1% pimavanserin vs.
<1% placebo), and fatigue (1% pimavanserin vs.
0% placebo).
Adverse reactions that occurred in 6-week, placebo-controlled studies and that were reported at an incidence of ≥2% and >placebo are presented in Table 1 .
Table 1 Adverse Reactions in Placebo-Controlled Studies of 6-Week Treatment Duration and Reported in ≥2% and >Placebo Percentage of Patients Reporting Adverse Reaction Pimavanserin 34 mg Placebo N=202 N=231 Gastrointestinal disorders Nausea 7% 4% Constipation 4% 3% General disorders Peripheral edema 7% 2% Gait disturbance 2% <1% Psychiatric disorders Hallucination 5% 3% Confusional state 6% 3% Adverse Reactions in Demographic Subgroups Examination of population subgroups in the 6-week, placebo-controlled studies did not reveal any differences in safety on the basis of age (≤75 vs.
>75 years) or sex.
Because the study population was predominantly Caucasian (91%; consistent with reported demographics for PD/PDP), racial or ethnic differences in the safety profile of pimavanserin could not be assessed.
In addition, in the 6-week, placebo-controlled studies, no clinically relevant differences in the incidence of adverse reactions were observed among those with a Mini-Mental State Examination (MMSE) score at entry of <25 versus those with scores ≥25.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of pimavanserin.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These reactions include rash, urticaria, reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea), somnolence, falls, agitation and aggression.