ADVERSE REACTIONS
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 clinical practice.
The safety of OXYTROL was evaluated in a total of 417 patients who participated in two clinical efficacy and safety studies and an open-label extension. Additional safety information was collected in earlier phase trials. In the two pivotal studies, a total of 246 patients received OXYTROL during the 12-week treatment periods. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received OXYTROL for at least 24 weeks and at least 36 weeks, respectively.
No deaths were reported during treatment. No serious adverse events related to treatment were reported.
Adverse reactions reported in the pivotal trials are summarized in Tables 1 and 2 below.
Table 1: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo group (Study 1).
|
Adverse Reaction
|
Placebo
(N = 132)
|
OXYTROL (3.9 mg/day)
(N = 125) |
| N |
% |
N |
% |
| Application site pruritus |
8 |
6.1% |
21 |
16.8% |
| Dry mouth |
11 |
8.3% |
12 |
9.6% |
| Application site erythema |
3 |
2.3% |
7 |
5.6% |
| Application site vesicles |
0 |
0.0% |
4 |
3.2% |
| Diarrhea |
3 |
2.3% |
4 |
3.2% |
| Dysuria |
0 |
0.0% |
3 |
2.4% |
Table 2: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo group (Study 2).
|
Adverse Reaction
|
Placebo
(N = 117)
|
OXYTROL (3.9 mg/day)
(N = 121) |
| N |
% |
N |
% |
| Application site pruritus |
5 |
4.3% |
17 |
14.0% |
| Application site erythema |
2 |
1.7% |
10 |
8.3% |
| Dry mouth |
2 |
1.7% |
5 |
4.1% |
| Constipation |
0 |
0.0% |
4 |
3.3% |
| Application site rash |
1 |
0.9% |
4 |
3.3% |
| Application site macules |
0 |
0.0% |
3 |
2.5% |
| Abnormal vision |
0 |
0.0% |
3 |
2.5% |
Most adverse reactions were described as mild or moderate in intensity. Severe application site reactions were reported by 6.4% of OXYTROL-treated patients in Study 1 and by 5.0% of OXYTROL-treated patients in Study 2.
Adverse reactions that resulted in discontinuation were reported by 11.2% of OXYTROL-treated patients in Study 1 and 10.7% of OXYTROL-treated patients in Study 2. Most of these discontinuations were due to application site reaction. In the two pivotal studies, no patient discontinued OXYTROL treatment due to dry mouth.
In the open-label extension, the most common treatment-related adverse reactions were: application site pruritus, application site erythema and dry mouth.
In a controlled clinical trial of skin sensitization, none of the 103 test subjects demonstrated skin hypersensitivity to OXYTROL.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of OXYTROL: dizziness and somnolence. 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.
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