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BOTOX® has safety and tolerability experience from +30 years of use in a range of conditions5-7*

BOTOX® is generally well-tolerated in neurogenic detrusor overactivity (NDO)7

Adapted from BOTOX® Summary of Product Characteristics. Accessed April 20227

§Procedure-related adverse reactions. **Elevated PVR not requiring catheterisation. Only in multiple sclerosis. aAdverse reactions occurring in the Phase 2 and pivotal Phase 3 clinical trials. bAdverse reactions occurring in the post-approval study of BOTOX® 100U in MS patients not catheterising at baseline. Please note, BOTOX® 100U is not licensed for NDO.


Clean intermittent catheterisation (CIC) rates with NDO7

Incidence of catheterisation among patients who were not catheterising at baseline prior to treatment§

Adapted from BOTOX® Summary of Product Characteristics. Accessed April 20227

§Study context: Two double-blind, placebo controlled, randomised phase 3 clinical studies, in 691 patients with urinary incontinence due to NDO, as a result of multiple sclerosis or spinal cord injury who were inadequately managed by ≥1 anticholinergic agent. To assess the efficacy, safety and effects on quality of life of BOTOX® patients with NDO. The primary end point was the mean reduction from baseline in UI episodes at Week 6 after treatment. Co-secondary end points were the mean increase in bladder capacity, maximum detrusor pressure during first involuntary detrusor contraction and incontinence related quality of life.7


CIC rates are higher in NDO than OAB4, however QoL was still improved in de novo catheterisers8

  • BOTOX® in NDO: Urinary retention 17% BOTOX® (n=227) vs 3% placebo (n=241)7
  • MS – 29% BOTOX® vs 4% placebo7; SCI – 5% BOTOX® vs 1% placebo7

QoL scores improved with BOTOX® regardless of whether patients needed to CIC or not8

Adapted from Allergan Ltd. Data on File 0408

Study context: The pooled results of two multicenter, double-blind, randomised, placebo-controlled, parallel group phase 3 clinical studies, in 142 patients with urinary incontinence due to NDO, to compare the safety and efficacy of BOTOX® versus placebo. The primary endpoint for both studies was the number of weekly episodes of urinary incontinence.8

Mean baseline scores: BOTOX® 200U non-CIC 31.33, BOTOX® 200U CIC 34.85.


CIC: clean intermittent catheterisation; I-QoL: incontinence quality of life; MS: multiple sclerosis; NDO: neurogenic detrusor overactivity; OAB: overactive bladder; QoL: quality of life; SCI: spinal cord injury; UI: urinary incontinence.

*BOTOX® is indicated for the management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics: neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord  injury (traumatic or non-traumatic), or multiple sclerosis.7

 

References

  1. Allergan. Data on file. INT/0423/2016
  2. Aurora S K, Winner P et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358-1373
  3. Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of onabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
  4. Allergan Ltd. Data on file 014
  5. Allergan. Data on file. INT/0423/2016(1). 2018
  6. Allergan. Data on file. INT/0572/2016(2). 2019
  7. BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk. Accessed April 2022
  8. Allergan Ltd. Data on File 040

Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use.

 

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/

Adverse events should also be reported to AbbVie on GBPV@abbvie.com 

 

Date of preparation: April 2022. UK-BUO-220024.