Safety
Adverse reactions: Pooled Study 1 and Study 21
| Adverse Reactions (≥3%) | PLACEBO n = 98 % |
GOCOVRI® 274 mg n = 100 % |
|---|---|---|
| Psychiatric disorders | ||
| Hallucinationa | 3 | 21 |
| Anxietyb | 3 | 7 |
| Insomnia | 2 | 7 |
| Depression/depressed mood | 1 | 6 |
| Abnormal dreams | 2 | 4 |
| Confusional state | 2 | 3 |
| Nervous system disorders | ||
| Dizziness | 1 | 16 |
| Headache | 4 | 6 |
| Dystonia | 1 | 3 |
| Gastrointestinal disorders | ||
| Dry mouth | 1 | 16 |
| Constipation | 3 | 13 |
| Nausea | 3 | 8 |
| Vomiting | 0 | 3 |
| General disorders and administration site conditions | ||
| Peripheral edema | 1 | 16 |
| Gait disturbance | 0 | 3 |
| Injury, poisoning, and procedural complications | ||
| Fall | 7 | 13 |
| Contusion | 1 | 6 |
| Infections and infestations | ||
| Urinary tract infection | 5 | 10 |
| Skin and subcutaneous tissue disorders | ||
| Livedo reticularis | 0 | 6 |
| Pigmentation disorder | 0 | 3 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 1 | 6 |
| Vascular disorders | ||
| Orthostatic hypotensionc | 1 | 13 |
| Eye disorders | ||
| Blurred vision | 1 | 4 |
| Cataract | 1 | 3 |
| Dry eye | 0 | 3 |
| Musculoskeletal and connective tissue disorders | ||
| Joint swelling | 0 | 3 |
| Muscle spasms | 0 | 3 |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasiad | 2 | 6 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough | 0 | 3 |
ARs, adverse reactions.
Other clinically relevant ARs observed at <3% included somnolence, fatigue, suicide ideation or attempt, apathy, delusions, illusions, and paranoia.
If your patient reports any adverse reactions, you should report them to the FDA at 1-800-FDA-1088 or fda.gov/medwatch.
| a | Includes visual hallucinations and auditory hallucinations. |
| b | Includes anxiety and generalized anxiety. |
| c | Includes orthostatic hypotension, postural dizziness, syncope, presyncope, and hypotension. |
| d | The denominator is all male patients in the safety population randomized to GOCOVRI® (n = 54) or placebo (n = 57). |
Most hallucinations were rated as mild and the majority (86%) were fully resolved
HALLUCINATIONS (POOLED SAFETY DATA)1-3
HALLUCINATIONS
21/100 (21%)
Investigator rating:
- 13 (62%) as mild
- 6 (29%) as moderate
- 2 (10%) as severe
Resolution of hallucinations:
- 18 (86%) fully resolved
- 12 (57%) resolved in ≤2 weeks
- 0 (0%) required hospitalization or
treatment with antipsychotics
- Patients <65 years old: 5/48 (10%)2
- Patients ≥65 years old: 16/52 (31%)2
- Majority of patients with PD are elderly and are more likely to have decreased renal function, which may put these patients at greater risk of adverse effects1
- Care should be taken in dose selection; observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases1
Pooled ARs leading to treatment discontinuations1
The overall pooled rate of discontinuation in at least 2% of patients due to ARs for patients treated with placebo was 8% vs 20% with GOCOVRI®1
| ADVERSE REACTIONS |
GOCOVRI® 274 mg n = 100 % |
Placebo n = 98 % |
|---|---|---|
| Hallucination | 8 | 0 |
| Dry mouth | 3 | 0 |
| Insomnia | 7 | 2 |
| Peripheral edema | 3 | 0 |
| Blurred vision | 3 | 0 |
| Postural dizziness and syncope | 2 | 0 |
| Abnormal dreams | 2 | 1 |
| Dysphagia | 2 | 0 |
| Gait disturbance | 2 | 0 |
In the EASE LID 2 OLE study
The safety profile of GOCOVRI® in this long-term study remained consistent with the pivotal trials4
ADVERSE EVENTS AND DISCONTINUATIONS DUE TO ADVERSE EVENTS (SAFETY POPULATION)
| ADVERSE EVENTS |
CONTINUING GOCOVRI® (n = 60) |
PREVIOUS PLACEBO (n = 78) |
ALL PATIENTS (N = 223) |
|---|---|---|---|
| Summary | |||
| Any AE | 57 (95.0%) | 70 (89.7%) | 205 (91.9%) |
| Study-drug related | 31 (51.7%) | 45 (57.7%) | 124 (55.6%) |
| Any SAE | 16 (26.7%) | 21 (26.9%) | 60 (26.9%) |
| Study-drug related | 1 (1.7%) | 3 (3.8%) | 5 (2.2%) |
| Any leading to study-drug discontinuation or death | 12 (20.0%) | 21 (26.9%) | 49 (22.0%) |
| Study-drug related | 4 (6.7%) | 15 (19.2%) | 31 (13.9%) |
| By preferred term* | |||
| Fall | 13 (21.7%) | 29 (37.2%) | 73 (32.7%) |
| Hallucination | 15 (25.0%) | 24 (30.8%) | 54 (24.2%) |
| Visual | 14 (23.3%) | 24 (30.8%) | 52 (23.3%) |
| Auditory | 1 (1.7%) | 1 (1.3%) | 5 (2.2%) |
| Peripheral edema | 10 (16.7%) | 12 (15.4%) | 36 (16.1%) |
| Constipation | 9 (15.0%) | 12 (15.4%) | 30 (13.5%) |
| Urinary tract infection | 7 (11.7%) | 8 (10.3%) | 23 (10.3%) |
| Dizziness | 4 (6.7%) | 10 (12.8%) | 22 (9.9%) |
| Nausea | 7 (11.7%) | 8 (10.3%) | 22 (9.9%) |
| Insomnia | 8 (13.3%) | 5 (6.4%) | 21 (9.4%) |
| Livedo reticularis | 6 (10.0%) | 5 (6.4%) | 20 (9.0%) |
| ON and OFF phenomenon | 7 (11.7%) | 4 (5.1%) | 18 (8.1%) |
| Dry mouth | 4 (6.7%) | 6 (7.7%) | 17 (7.6%) |
| * | Includes all preferred terms with an incidence ≥7.5% among all patients. |
| AE, adverse event; SAE, serious adverse event. |
- Discontinuations due to adverse events occurred more frequently among patients initiating GOCOVRI® in this study, compared to those who continued on GOCOVRI® from phase 3 trials4
- Discontinuations tended to occur in the first weeks of treatment around dose initiation and titration4
- No new safety signals were observed in this open-label extension4
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