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adverse reactions
6 ADVERSE REACTIONS The most common adverse reactions with SANCTURA XR ® were dry mouth (10.7%) and constipation (8.5%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan, Inc. at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The data described below reflect exposure to SANCTURA XR ® capsules in 578 patients for 12 weeks in two Phase 3 double-blind, placebo controlled trials (n=1165). These studies included overactive bladder patients of ages 21 to 90 years, of which 86% were female and 85% were Caucasian. Patients received 60 mg daily doses of SANCTURA XR ® . Patients in these studies were eligible to continue treatment with SANCTURA XR ® 60 mg for up to one year. From both these controlled trials combined, 769 and 238 patients received treatment with SANCTURA XR ® for at least 24 and 52 weeks, respectively. There were 157 (27.2%) SANCTURA XR ® patients and 98 (16.7%) placebo patients who experienced one or more double-blind treatment-emergent adverse events (TEAEs) that were assessed by the investigator as at least possibly related to study medication. The most common TEAEs were dry mouth and constipation which, when reported, commonly occurred early in treatment (often within the first week). In the two Phase 3 studies, constipation, dry mouth, and urinary retention led to discontinuation in 1%, 0.7%, and 0.5% of patients treated with SANCTURA XR ® 60 mg daily, respectively. In the placebo group, there were no discontinuations due to dry mouth or urinary retention and one due to constipation. The incidence of serious adverse events was similar among patients receiving SANCTURA XR ® and patients receiving placebo. No treatment-emergent serious adverse events in either treatment group were judged by the investigators as being possibly related to the study medication. Table 1 lists those treatment emergent adverse events from the trials that were assessed by the investigator as possibly related to study medication, reported in at least 1% of SANCTURA XR ® patients, and were more common for the SANCTURA XR ® group than for placebo. Table 1: Incidence of treatment-emergent adverse events reported in at least 1% of patients judged by the investigator as at least possibly related to treatment and more common for the SANCTURA XR ® group than for placebo MedDRA Preferred term Number of patients (%) Placebo N=587 SANCTURA XR ® N=578 Dry mouth 22 (3.7) 62 (10.7) Constipation 9 (1.5) 49 (8.5) Dry eye 1 (0.2) 9 (1.6) Flatulence 3 (0.5) 9 (1.6) Nausea 2 (0.3) 8 (1.4) Abdominal pain 2 (0.3) 8 (1.4) Dyspepsia 4 (0.7) 7 (1.2) Urinary tract infection 5 (0.9) 7 (1.2) Constipation aggravated 3 (0.5) 7 (1.2) Abdominal distension 2 (0.3) 6 (1.0) Nasal dryness 0 (0.0) 6 (1.0) Additional adverse events reported in less than 1% of SANCTURA XR ® - treated patients and more common for SANCTURA XR ® than placebo, judged by the investigator at least possibly related to treatment were: vision blurred, feces hard, back pain, somnolence, urinary retention, and dry skin. Table 2 lists all treatment-emergent adverse events for the trials reported in at least 2% of all SANCTURA XR ® patients and more common for the SANCTURA XR ® group than for placebo without regard to the investigator's judgment on drug relatedness. Table 2: Incidence of treatment-emergent adverse events reported in at least 2% of patients regardless of reported relationship to treatment and more common for the SANCTURA XR ® group than for placebo MedDRA Preferred term Number of patients (%) Placebo N=587 SANCTURA XR ® N=578 Dry mouth 22 (3.7) 64 (11.1) Constipation 10 (1.7) 52 (9.0) Urinary tract infection 29 (4.9) 42 (7.3) Nasopharyngitis 10 (1.7) 17 (2.9) Influenza 9 (1.5) 13 (2.2) Additional adverse events reported in less than 2% of SANCTURA XR ® - treated patients and twice as frequent for SANCTURA XR ® compared to placebo, regardless of reported relationship to treatment were: tachycardia, dry eyes, abdominal pain, dyspepsia, abdominal distension, constipation aggravated, nasal dryness, and rash. In the open-label treatment phase, the most common TEAEs reported in the 769 patients with at least 6 months exposure to SANCTURA XR ® were: constipation, and dry mouth. Urinary tract infection and rash was also reported in several patients, including one of each judged by the investigator to be possibly related to treatment. Several adverse events were reported as severe in the open-label treatment phase, including one urinary tract infection, two urinary retention events, and one aggravated constipation. Electrophysiology The effect of 20 mg twice daily and up to 100 mg twice daily of an immediate-release formulation of trospium chloride on QT interval was evaluated in a single-blind, randomized, placebo and active (moxifloxacin 400 mg daily) controlled, 5-day parallel trial in 170 male and female healthy volunteer subjects aged 18 to 45 years. The QT interval was measured over a 24-hour period at steady state. Trospium chloride was not associated with an increase in individual corrected (QTcI) or Fridericia corrected (QTcF) QT interval at any time during steady state measurement, while moxifloxacin was associated with a 6.4 msec increase in QTcF. In this study, asymptomatic, non-specific T-wave inversions were observed more often in subjects receiving trospium chloride than in subjects receiving moxifloxacin or placebo following five days of treatment. The clinical significance of T-wave inversion in this study is unknown. This finding was not observed during routine safety monitoring in overactive bladder patients from 2 placebo-controlled clinical trials in 591 patients treated with 20 mg twice daily of immediate-release trospium chloride, nor was it observed in 2 placebo-controlled clinical trials in 578 patients treated with SANCTURA XR ® capsules. Also in this study, the immediate-release formulation of trospium chloride was associated with an increase in heart rate that correlated with increasing plasma concentration, with a mean elevation in heart rate compared to placebo of 9 beats per minute for the 20 mg dose and of 18 beats per minute for the 100 mg dose. In the two Phase 3 SANCTURA XR ® trials the mean increase in heart rate compared to placebo was approximately 3 beats per minute in both studies. 6.2 Post-marketing Experience The following adverse reactions have been identified during European and US postapproval use of trospium chloride 20 mg twice daily. Reported events have included: Gastrointestinal – gastritis; Cardiovascular – palpitations, supraventricular tachycardia, chest pain, syncope, “hypertensive crisis”; Immunological – Stevens-Johnson syndrome, anaphylactic reaction, angioedema; Nervous System – vision abnormal, hallucinations and delirium; Musculoskeletal – rhabdomyolysis; General – rash.