recautions (5.10)]
Seizures [see Warnings and Precautions (5.11)]
Dysphagia [see Warnings and Precautions (5.12)]
Priapism [see Warnings and Precautions (5.13)]
Body Temperature Regulation [see Warnings and Precautions (5.14)]
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 safety of PERSERIS was eva luated in a total of 814 adult subjects with schizophrenia who received at least 1 dose of PERSERIS during the clinical development program. A total of 322 subjects were exposed to PERSERIS for at least 6 months, of which 234 subjects were exposed to PERSERIS for at least 12 months; 281 and 176 of these, respectively, received the 120 mg dose.
Adverse drug reactions in adult subjects with schizophrenia (≥ 5% in any PERSERIS-treated group and greater than placebo) during the 8-week double-blind, placebo-controlled study) were weight increased, constipation, sedation/somnolence, pain in extremity, back pain, akathisia, anxiety, and musculoskeletal pain. In addition, the frequency of reported injection site reactions was similar across treatment groups with both PERSERIS and placebo; the most common (≥ 5%) of which were injection site pain, and erythema. The systemic safety profile for PERSERIS, was consistent with the known safety profile of oral risperidone.
Commonly-Observed Adverse Drug Reactions in Double-Blind, Placebo-Controlled Clinical Studies – Schizophrenia
Adverse Reactions with an incidence of 2% or more and greater than placebo are shown in TABLE 4.
Table 4. Adverse Drug Reactions in 2% or More of PERSERIS-Treated Subjects (and Greater than Placebo) in an 8-Week Double-Blind, Placebo-Controlled Study
* Sedation includes sedation and somnolence
System Organ Class
Preferred Term PERSERIS
90 mg
(n = 115) PERSERIS
120 mg
(n = 117) Placebo
(n = 118)
Percentage of Subjects Reporting ADR
Gastrointestinal disorders
Constipation 7.0 7.7 5.1
Abdominal discomfort 2.6 2.6 1.7
Dry mouth 1.7 2.6 1.7
Investigations
Weight increased 13.0 12.8 3.4
Metabolism and nutrition disorders
Increased appetite 1.7 3.4 1.7
Musculoskeletal and connective tissue disorders
Back pain 3.5 6.8 4.2
Pain in extremity 0.9 7.7 5.1
Musculoskeletal pain 5.2 5.1 2.5
Musculoskeletal stiffness 2.6 0.9 1.7
Muscle spasms 0 2.6 0
Nervous system disorders
Sedation* 7.0 7.7 0
Akathisia 2.6 6.8 4.2
Extrapyramidal disorder 4.3 1.7 0.8
Psychiatric disorders
Anxiety 2.6 6.8 5.1
Other Adverse Dru |
