ADVERSE REACTIONS
In all clinical studies combined, a total of 308 patients were treated with Striant® for up to 12 months
Twelve Week Trials
In the pivotal, Phase 3, open-label controlled study (Study 1), 98 patients received Striant® for up to 12 weeks. Adverse events judged possibly, probably, or definitely related to the use of Striant® and reported by >/= 1% of patients in Study 1 are listed in Table 2.
Table 2. Incidences of Adverse Events Possibly, Probably or Definitely Related Use of Striant® in Study 1
| Adverse event |
Striant®
(n=98)
|
| Gum or Mouth Irritation |
9.2% |
| Taste Bitter |
4.1% |
| Gum Pain |
3.1% |
| Gum Tenderness |
3.1% |
| Headache |
3.1% |
| Gum Edema |
2.0% |
| Taste Perversion |
2.0% |
Please see " Gum-related adverse events and gum examinations " subsection for further information. The majority of gum-related adverse events were transient. Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days.
The following adverse events judged possibly, probably or definitely related to the use of Striant® occurred in 1 patient each in Study 1: abdominal cramp, acne, anxiety, asthma (acute), breast enlargement, breast pain, buccal mucosal roughening, difficulty in micturition, fatigue, gingivitis, gum blister, gustatory sense diminished, hematocrit increased, lipids serum increased, liver function tests abnormal, nose edema, stinging of lips, and toothache.
There was one additional 12-week study in 12 patients. In this study, additional adverse events judged at least possibly related to Striant® and reported by 1 patient each included emotional lability and hypertension.
Long-Term Extension Trials
In two long-term extension trials, a total of 117 and 51 patients received Striant® for at least 6 months and 1 year, respectively.
Of 117 patients treated for at least 6 months, adverse events judged possibly, probably, or definitely related to treatment and reported by 1 patient each included: anxiety, buccal inflammation, depression, dry mouth, gastrointestinal disorder, gum redness, hypertension, infection, medication error, nausea, pruritis, renal function abnormal, stomatitis, taste bitter, taste perversion, and toothache. Polycythemia and increased serum prostate specific antigen (PSA) were reported in three and two patients, respectively.
Adverse events reported in the 51 patients treated for at least one year were similar to those reported after 6 months of treatment and lower in incidence.
Gum-related adverse events and gum examinations
In the pivotal controlled study (Study 1), all reported gum-related adverse events were collected and gum examinations were conducted at Baseline and every month thereafter.
In Study 1, a total of 16 patients reported 19 gum-related adverse events. Of these, ten patients (10.2%) reported 12 events of mild intensity, four patients (4.1%) reported 5 events of moderate intensity, and two patients (2.0%) reported 2 events of severe intensity. Most of these events were judged probably or definitely related to treatment with Striant®. Four patients (4.1%) discontinued treatment with Striant® due to gum or mouth-related adverse events including two with severe gum irritation, one with mouth irritation, and one with "bad taste in mouth". The majority of gum-related adverse events were transient. Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days.
In Study 1, monthly gum examinations were conducted to assess for gingivitis, gum edema, oral lesions, ulcerations or leukoplakia. No cases of ulceration or leukoplakia were observed. No new oral lesions were observed. Gingivitis was common at Baseline (32.6%), and was reduced at Week 4 (10.2%), Week 8 (10.2%) and Week 12 (11.2%). Similar findings were seen for gum edema.
In the two long-term extension trials, gum examinations were conducted every 3 months while on treatment. In one of these trials, no patient had a gum abnormality, and in the other trial, moderate gingivitis and mild gum edema were reported by 1 patient each.
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