Overactive Bladder

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BOTOX® safety profile for OAB is well characterized

Most common adverse events in BOTOX® pivotal studies

Adverse reactions1,*

BOTOX® 100 Units(n = 552)

Placebo(n = 542)

Urinary tract infection (UTI)

18%

6%

Dysuria

9%

7%

Urinary retention

6%

0%

Bacteriuria

4%

2%

Residual urine volume

3%

0%

UTI was defined as a positive urine culture regardless of symptoms2,3:

  • Bacteriuria count of > 105 colony-forming units (CFU)/mL AND leukocyturia > 5/high power field (hpf)

Urinary retention was2,3:

  • NOT defined as the complete inability to go
  • Defined using Post-void Residual Volume (PVR) thresholds and associated symptoms such as voiding difficulties or sensation of bladder fullness

Elevated PVR urine volume not requiring catheterization. Catheterization was required for PVR ≥ 350 mL regardless of symptoms, and for PVR ≥ 200 mL to < 350 mL with symptoms (eg, voiding difficulty)1

*Adverse reactions reported by ≥ 2% of BOTOX® treated patients and more often than in placebo-treated patients within the first 12 weeks.1

1.4% OF BOTOX® PATIENTS DISCONTINUED DUE TO ADVERSE EVENTS (n = 552)4

• In pivotal studies, 1.4% of BOTOX® patients (n = 552) discontinued due to adverse events vs 1.7% of placebo patients (n = 542)

Most BOTOX® patients did not initiate CIC* and could still spontaneously void1,5,6

93.5%

In pivotal studies, 93.5% of BOTOX® patients did NOT initiate CIC1 (n = 552)

  • Based on a post hoc, pooled analysis that included open-label study data, the rate of CIC use was lower in younger patients (< 50) years5

*CIC = clean intermittent catheterization.

99.8%

Based on post hoc, pooled analysis of 2 pivotal studies, 99.8% of BOTOX® patients were able to spontaneously void6

  • 1 out of 551 patients had complete inability to void6
  • Patients spontaneously voiding included those who voided with or without CIC6

Limitation: The post hoc analyses were not prespecified endpoints and not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.

Most common adverse events in BOTOX® open-label extension7

Adverse events with ≥ 3% incidence in any treatment cycle through week 12.

  • AE rates were similar over repeat BOTOX® treatments7

Patients were less likely to need CIC in subsequent BOTOX® treatments if they did not require CIC after the first treatment7

Percentage of patients initiating CIC due to incomplete bladder emptying†/PVR volume who had never initiated CIC before7:

†Retention.

Study design: Open-label, 3-year extension of 2 double-blind, placebo-controlled, randomized, multicenter, phase 3, 24-week clinical studies in OAB patients with symptoms of urge urinary incontinence (UUl), urgency, and frequency who had an inadequate response to or intolerable side effects on anticholinergic therapy. Eligible patients had to have completed the double-blind portion, have 12 or more weeks since their last treatment, at least 2 UUl episodes within 3 days, and a PVR volume less than 200 mL. Patients were retreated with BOTOX® 100 Units as needed but no sooner than 12 weeks since the last treatment. Co-primary endpoints were the mean change from baseline in daily Ul episodes and the proportion of patients reporting a positive response on the Treatment Benefit Scale (TBS) at week 12. Data are presented in discrete subgroups of patients who received 1, 2, 3, 4, 5, or 6 treatments.7

NOTE: A total of 430 patients completed the entire 3-year extension. The median duration of effect of BOTOX® was 7.6 months, and 65.7% of patients had a retreatment time > 6 months. Thus, many of the patients who completed the 3-year extension received < 6 treatments. This is one of the reasons for the smaller n-values at 5 and 6 treatments. Subjects discontinued for various reasons, including but not limited to, personal reasons, protocol violations/lost to follow-up, adverse events, lack of efficacy, etc.