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Uracyst. A summary of the rationale and clinical evidence. Abbreviated Prescribing Information can be found on the last slide of this presentation. PMR-NOV-2010-0615 Date of Preparation: November 2010. . Uracyst . 2% solution of sodium chondroitin sulfate Medical device

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slide1

Uracyst

A summary of the rationale and clinical evidence

Abbreviated Prescribing Information can be found on the last slide of this presentation.

PMR-NOV-2010-0615

Date of Preparation: November 2010.

uracyst
Uracyst
  • 2% solution of sodium chondroitin sulfate
  • Medical device
  • Indicated for the replenishment of the GAG layer in the bladder, for patients with damaged or GAG deficient bladder epithelium
  • Available in 20ml vials (400mg of chondroitin sulfate per vial)
roadmap

Mode of Action

Uracyst

Clinical Evidence

Cost comparison

Instillation of Uracyst

Roadmap
mode of action of chondroitin sulfate in pbs ic
Mode of action of chondroitin sulfate in PBS/IC

Control bladder

Damaged bladder

Fate of Texas Red labelled chondroitin sulfate after bladder damage with trypsin

roadmap1

Mode of Action

Uracyst

Clinical Evidence

Cost comparison

Instillation of Uracyst

Roadmap
study 1 nickel et al 2008 10
Study 1 - Nickel et al 200810
  • Aim
    • To assess the efficacy and safety of intravesical 2% chondroitin sulfate (Uracyst) in the treatment of patients with a clinical diagnosis of IC
  • Method
    • Fifty-three patients with IC were enrolled in a multicentre, community-based, open-label study, and received intravesical instillations of Uracyst once a week for six weeks, then once a month for 16 weeks
  • Endpoints
    • The primary endpoint - the percentage of responders to treatment at week 10*

* assessed by a Global Response Assessment (GRA) scale

slide15

View Dr Curtis Nickel’s Presentation

View an interview with Dr Curtis Nickel

study 2 nickel et al 2009 11
Study 2 - Nickel et al 200911
  • Aim
    • To assess the efficacy of 6 similar weekly treatments of Uracyst (2% chondroitin sulfate) versus a placebo control.
  • Method
    • Sixty-five patients were randomised to receive either 6 once-weekly treatments of Uracyst or the intravesical placebo control.
  • Endpoints
    • The primary efficacy endpoint was the percent responders to treatment. A responder was defined as those subjects who had indicated “markedly improved” or “moderately improved”on a 7 point Global Response Assessment (GRA) scale.
tolerability
Tolerability
  • Uracyst is well tolerated with no significant safety issues apparent during either efficacy study10,11
  • No serious adverse events have been reportedwith clinical use
  • Most issues tend to arise from complications with the catheterisation process
roadmap2

Mode of Action

Uracyst

Clinical Evidence

Cost comparison

Instillation of Uracyst

Roadmap
cost comparison gag instillations for pbs ic
Cost comparison – GAG instillations for PBS/IC

*Gepan Business Case, de Smit Medical

** Cystistat advertisement, Pliva

***iAluRil advertisement, Aspire Pharma

roadmap3

Mode of Action

Uracyst

Clinical Evidence

Cost comparison

Instillation of Uracyst

Roadmap
instillation of uracyst
Instillation of Uracyst

Uracyst

in bladder

Catheter

suggested uracyst treatment plan
Suggested Uracyst treatment plan
  • Weekly instillations for 4-6 weeks, then monthly thereafter
  • Optimum response within 4-6 months
  • Revert back to weekly treatment in cases of symptom flare-up
  • More frequent therapy may be required in patients with severe PBS/IC
summary
Summary
  • PBS/IC patients often have a specific deficit of chondroitin sulfate on the surface of the bladder wall
  • Intravesical chondroitin sulfate binds extensively to the damaged bladder wall surface, helping to re-establish the GAG layer - the first-line of defence against urine
  • Uracyst is effective and well tolerated in the treatment of PBS/IC
references
References

1. Screening, treatment and management of interstitial cystitis/painful bladder syndrome. Clinical Proceedings. Association of Reproductive Health Professionals. April 2008.

2. Rosenberg M , Newman D and Page S. Interstitial cystitis/painful bladder syndrome: Symptom recognition is key to early identification, treatment. Cleveland Clinic Journal of Medicine. 2007; 74 (S3): S54-S62..

3. Hurst RE, Roy J and Parsons C. The role of Glycosaminoglycans in normal bladder physiology and the pathophysiology of interstitial cystitis. Interstitial Cystitis. 1997. Philadelphia. Lippincott-Raven Publishers.

4. Kelada E and Jones A. Interstitial cystitis. Arch Gynecol Obstet. 2007; 275:223-229.

5. Hurst RE et al. A deficit of proteoglycans on the bladder uroepithelium in interstitial cystitis. European Urology Supplements. 2 (2003) 10-13.

6. Hurst RE et al. Functional and structural characteristics of the glycosaminoglycans of the bladder luminal surface. The Journal of Urology. 1987; 138: 433-437.

7. Hurst RE et al. A deficit of chondroitin sulfate proteoglycans on the bladder uroepithelium in interstitial cystitis. Urology. 1996;48 (5); 817-821.

8. Kyker K, Coffman J and Hurst RE. Exogenous glycosaminoglycans coat damaged bladder surfaces in experimentally damaged mouse bladder. BMC Urology. 2005; 5:4

9. Hauser P et al. Restoring barrier function to acid damaged bladder by intravesical chondroitin sulfate. J Urol 2009; 182: 2477-2482.

10. Nickel JC et al. A real-life multicentre clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis. BJU International. Epub 3 September 2008.

11. Nickel JC et al. Chondroitin sulfate is a promising therapy for interstitial cystitis/painful bladder syndrome (IC/PBS). Abstract P114 presented at NAUA, October 2009. CUAJ 2009; 3(Suppl 3): S170.

12. Instillation of Uracyst Information Sheet. Stellar Pharmaceuticals Inc. September 2006.

13. Uracyst Package Insert. Stellar Pharmaceuticals. November 2008.

14. Interstitial cystitis and Uracyst Patient Information Booklet. Stellar Pharmaceuticals Inc.

uracyst prescribing information
Uracyst Prescribing Information

The full Prescribing Information should be consulted prior to use.

Uracyst®Abbreviated Prescribing Information.

Description: Each ml of Uracyst contains 20mg sodium chondroitin sulfate (400mg of chondroitin sulfate per 20ml vial). Chondroitin sulfate is an acidic mucopolysaccharide and is one of the glycosaminoglycans (GAGs). The luminal surface of the bladder is coated with a layer of GAGs that provide a protective impermeable barrier to the bladder. Damage to this GAG layer may result in deficiencies to its protective barrier, inducing irritations in the bladder wall. Chondroitin sulfate is an important component of the bladder GAGs that can replenish the deficient GAG layer on the bladder epithelium.

Indications: For replenishment of the glycosaminoglycan (GAG) layer in the bladder, for patients with damaged or GAG deficient bladder epithelium.

Dosage and administration: Instil 20ml into the bladder after any residual urine has been removed. For optimum results, Uracyst should be used full strength without dilution, and retained in the bladder as long as possible (not less than 30 minutes). Repeat the instillation of 20ml weekly for 4 to 6 weeks, then, monthly thereafter until symptoms are relieved. Most patients benefit from 6 weekly 20ml instillations, then monthly instillations thereafter depending on their symptomatic response.

Contraindications: Do not administer to patients with known hypersensitivity to the solution.

Warnings: For Bladder Instillation only. Uracyst contains neither preservatives nor antimicrobials; therefore, any unused portion must be discarded.

Precautions: Bring the contents of vial to room temperature before use.

Adverse effects: No known adverse effects. Short-term discomfort may be caused by the catheterisation process.

Legal category: Medical device.

CE Number: CE 0473.

CE Mark Holder: Stellar Pharmaceuticals Inc, 544 Egerton Street, London, Ontario, Canada N5W 3Z8.

Package quantities and price: Single-dose glass vial of 20ml. Packages of four: £260 (UK), €300 (Ireland).

Storage: Store 2 to 25oC. Do not freeze. Discard unused portions. Distributed by: Galen Limited. Date of preparation: May 2009.

Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA. Galen Ireland, c/o Allphar Services Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin, Ireland. Telephone: +44 (0) 28 3833 4974. Fax: +44 (0) 28 3839 1640. Website: www.galen.co.uk. Email: info@galen.co.uk.

Adverse incidents should be reported. Reporting forms and information can be found at www.mhra.gov.uk or www.imb.ie. Adverse incidents should also be reported to Galen Limited on +44 (0)28 3833 4974 and select the customer services option, or e-mail info@galen.co.uk. Medical information enquiries should also be directed to Galen Limited.