Introduction to VESIcare LS
VESIcare LS, an oral suspension of solifenacin succinate, is a muscarinic antagonist approved by the FDA for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older. This approval marks a significant milestone in the management of bladder dysfunction in young patients.
Clinical Trials Overview
The efficacy of VESIcare LS was established through two clinical trials involving a total of 95 pediatric patients with NDO, aged 2 to 17 years[1][4].
Trial Design and Outcomes
- Patient Groups: The trials included two age groups: patients aged 2 to less than 5 years and those aged 5 to 17 years.
- Primary Efficacy Endpoint: The primary goal was to measure the maximum amount of urine the bladder could hold after 24 weeks of treatment.
- Results:
- In the first study, 17 patients aged 2 to less than 5 years showed an average increase of 39 mL in bladder capacity.
- In the second study, 49 patients aged 5 to 17 years demonstrated an average increase of 57 mL in bladder capacity[1][4].
- Additional Benefits: Both studies observed reductions in bladder pressure, spontaneous bladder contractions, and the number of incontinence episodes.
Dosage and Administration
The dosing of VESIcare LS is weight-based and administered once daily. Here are the recommended starting and maximum doses:
Weight Range |
Starting Dose |
Maximum Dose |
9 kg to 15 kg |
2 mL |
4 mL |
> 15 kg to 30 kg |
3 mL |
5 mL |
> 30 kg to 45 kg |
3 mL |
6 mL |
> 45 kg to 60 kg |
4 mL |
8 mL |
> 60 kg |
5 mL |
10 mL |
Patients should take VESIcare LS orally followed by a liquid, such as water or milk[2].
Safety and Contraindications
Urinary Retention
The use of VESIcare LS in patients with clinically significant bladder outlet obstruction may result in urinary retention. It is not recommended in such patients without clean intermittent catheterization[2].
Gastrointestinal Disorders
VESIcare LS is contraindicated in patients with gastric retention and not recommended in those with conditions associated with decreased gastrointestinal motility due to the risk of further decreased motility[2].
Market Analysis
Market Growth
The solifenacin succinate market, including VESIcare LS, is projected to grow significantly. According to market forecasts, this segment is expected to experience a Compound Annual Growth Rate (CAGR) of 50.90% from 2024 to 2031[5].
Patent and Clinical Trial Landscape
- Patents: VESIcare LS has a robust patent profile with 23 international patents and 1 US patent.
- Clinical Trials: There have been numerous clinical trials, with 67 trials listed, indicating ongoing research and development in this area[5].
Market Competition
The approval of VESIcare LS for pediatric use opens up a new market segment, but it also faces competition from other antimuscarinic drugs. However, its unique formulation as an oral suspension makes it particularly suitable for pediatric patients, giving it a competitive edge.
Projections and Future Outlook
Market Expansion
Given the significant growth projected for the solifenacin succinate market, VESIcare LS is poised to capture a substantial share. The drug's approval for pediatric use expands its market potential beyond adult patients with overactive bladder.
Ongoing Research
Recent clinical trials, including Phase 1 and Phase 4 studies, indicate continued research efforts to further establish the safety and efficacy of VESIcare LS. This ongoing research may lead to additional approvals or new indications, further boosting market growth[5].
Key Takeaways
- Clinical Efficacy: VESIcare LS has demonstrated significant efficacy in increasing bladder capacity and reducing incontinence episodes in pediatric patients with NDO.
- Market Growth: The market for solifenacin succinate, including VESIcare LS, is expected to grow at a CAGR of 50.90% from 2024 to 2031.
- Safety Considerations: The drug has specific contraindications and precautions, particularly regarding urinary retention and gastrointestinal disorders.
- Ongoing Research: Continued clinical trials and research efforts are expected to further solidify VESIcare LS's position in the market.
FAQs
What is VESIcare LS used for?
VESIcare LS is used for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older.
How is VESIcare LS administered?
VESIcare LS is administered orally as a suspension, once daily, with the dose based on the patient's weight.
What were the key findings from the clinical trials?
The clinical trials showed significant increases in bladder capacity and reductions in bladder pressure, spontaneous bladder contractions, and incontinence episodes.
What are the contraindications for VESIcare LS?
VESIcare LS is contraindicated in patients with gastric retention and not recommended in those with clinically significant bladder outlet obstruction or conditions associated with decreased gastrointestinal motility.
What is the projected market growth for VESIcare LS?
The market for solifenacin succinate, including VESIcare LS, is expected to grow at a CAGR of 50.90% from 2024 to 2031.
Sources
- FDA Approves VESIcare for Pediatric Use - Contemporary Pediatrics
- VESIcare LS: Package Insert / Prescribing Information - Drugs.com
- Summary Basis of Decision for Vesicare - Health Products and Food Branch
- FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients - FDA
- VESICARE LS Drug Patent Profile - DrugPatentWatch