For major depressive disorder (Adjunctive) in adultsSexual side effects and EPS
Reports of sexual side effects and EPS-related TEAEs1-3
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| Pooled safety data from 6-week trials (Study 501 and 502) and a 6‑month, open-label safety trial (Study 503) | |||
|---|---|---|---|
| 6-WEEK TRIALS | 6-MONTH, OPEN LABEL SAFETY TRIAL* | ||
| SEXUAL DYSFUNCTION (% OF PATIENT REPORTING)† | CAPLYTA + ADT (n=483) | Placebo + ADT (n=481) | CAPLYTA + ADT (n=809) |
| Patients with ≥ 1 dysfunction TEAE | 0.4% | 0.2% | |
| EPS-RELATED TEAEs | |||
| Akathisia | 0.8% | 0.4% | 0.4% |
| Restlessness | 0.2% | 0.4% | 0.7% |
| ≥1 EPS-related TEAE (excluding akathisia and restlessness)‡ | 5.0% | 0.8% | 3.2% |
| Pooled safety data from 6-week trials (Study 501 and 502) and a 6‑month, open-label safety trial (Study 503) | |||
|---|---|---|---|
| 6-WEEK TRIALS | 6-MONTH, OPEN LABEL SAFETY TRIAL* | ||
| SEXUAL DYSFUNCTION (% OF PATIENT REPORTING)† | CAPLYTA + ADT (n=483) | Placebo + ADT (n=481) | CAPLYTA + ADT (n=809) |
| Patients with ≥ 1 dysfunction TEAE | 0.4% | 0.2% | |
| EPS-RELATED TEAEs | |||
| Akathisia | 0.8% | 0.4% | 0.4% |
| Restlessness | 0.2% | 0.4% | 0.7% |
| ≥1 EPS-related TEAE (excluding akathisia and restlessness)‡ | 5.0% | 0.8% | 3.2% |
No notable changes from baseline on clinician-rated objective measures of movement disorders (AIMS, BARS, SAS).1-3
*Limitation: This open-label safety extension trial was designed primarily to assess long-term safety and tolerability.
In 6-week trials, reported sexual side effects and akathisia were not common (<1% for each).2
WARNINGS & PRECAUTIONS: Antipsychotic drugs have been reported to cause:
- Tardive Dyskinesia (TD) may develop in patients treated with antipsychotic drugs, including CAPLYTA. TD can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. The TD risk appears to be highest in elderly women. The likelihood that TD will become irreversible increases with the duration of the antipsychotic drug treatment and cumulative dose. If signs and symptoms of TD appear, consider discontinuing CAPLYTA if clinically appropriate.
Please see additional Important Safety Information, including Boxed WARNINGS, below.
†Data from 6-week trials only. Pooled incidence of TEAEs related to sexual dysfunction included erectile dysfunction, loss of libido, sexual dysfunction, and decreased libido.2
‡Based on Broad SMQ definition and includes patients with tremor, bradykinesia, muscle spasm, gait disturbance, tongue spasm, muscle tightness, dyskinesia, extrapyramidal disorder, muscle contraction involuntary, bradyphrenia, or musculoskeletal stiffness; excluding akathisia and restlessness.2
ADT=antidepressant therapy; AIMS=Abnormal Involuntary Movement Scale; BARS=Barnes Akathisia Rating Scale; EPS=extrapyramidal symptoms; SAS=Simpson-Angus Scale; SMQ=Standardised MedDRA Queries; TEAE=treatment emergent adverse events.
