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NICE draft guidance: Pentosan polysulfate sodium for treating bladder pain syndrome

Elmiron, for Bladder pain syndrome from Consilient Health Ltd

The National Institute for Health and Care Excellence (NICE) have published draft guidance recommending use of Consilient Health's bladder pain treatment pentosan polysulfate sodium, brand name Elmiron, as an option for treating bladder pain syndrome with glomerulations or Hunner’s lesions in adults with urinary urgency and frequency, and moderate to severe pain, providing condition has not responded to an adequate trial of standard oral treatments.

The full guidance is expected to be published in November 2019.

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Why the committee made these recommendations
Bladder pain syndrome causes extreme pain and severely affects quality of life. It is challenging to treat and there is an unmet need for other treatments. It is currently managed with oral treatments, then bladder instillations if symptoms don’t improve. Pentosan polysulfate sodium is an oral treatment.

Clinical trials suggest that pentosan polysulfate sodium may be more effective at relieving pain than placebo. A comparison of clinical trials that includes best supportive care and bladder instillations suggests that pentosan polysulfate sodium may have a modest benefit over these alternatives. But how much benefit it provides is unclear because these treatments haven’t been compared directly. Also, the available evidence is not of high quality.

Pentosan polysulfate sodium is not cost effective compared with best supportive care. But the most plausible cost-effectiveness estimates for pentosan polysulfate sodium compared with bladder instillations are likely to be a cost-effective use of NHS resources. So, it is recommended for a defined population.

About Elmiron (source EMA)
Elmiron is a medicine used to treat adults with bladder pain syndrome, a condition of the bladder which causes pain in the pelvic area and a frequent, urgent need to pass urine.

Elmiron is used in patients with moderate to severe pain and who have small bleeds or lesions (sores) in the bladder wall.

Elmiron contains the active substance pentosan polysulfate sodium.

The way the active substance in Elmiron, pentosan polysulfate sodium, works is not fully understood but it passes into the urine and is thought to attach to and help repair the protective layer of mucus lining the bladder, which is deficient in patients with bladder pain syndrome. This reinforcement of the protective layer may reduce inflammation and bladder pain.

Elmiron was first made available in the EU in 2017. It is manufactured by Consilient Health.

Sources
European Medicines Agency website page for Elmiron
Accessed 15/10/19
Links available in External Resources

© NICE [2019]

Pentosan polysulfate sodium for treating bladder pain syndrome [ID1364]. In development [GID-TA10335]. Expected publication date: 13 November 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

The information provided by NICE was accurate at the time this article was issued.


NICE draft guidance: Pentosan polysulfate sodium for treating bladder pain syndrome

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