CHMP Backs Pentosan Polysulfate (Elmiron) for Bladder Pain Syndrome

Megan Brooks


March 27, 2017

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommend pentosan polysulfate sodium (Elmiron, bene-Arzneimittel GmbH) for treatment of bladder pain syndrome characterized by glomerulations or Hunner's lesions in the urine bladder mucosa in adults with moderate to severe pain, urgency, and frequency of micturition.

Elmiron was designated as an orphan medicinal product in January 2015. It will be available as 100-mg hard capsules.

Pentosan polysulfate sodium, the active ingredient in Elmiron, is thought to have a local effect in the bladder after systemic administration and excretion into the urine by binding to and repairing the glycosaminoglycan layer in the deficient mucous of the bladder, the EMA explains in a news release.

"The benefits with Elmiron are its ability to relieve pain and urgency as well as to improve overall symptoms of the disease in adults with bladder pain syndrome," they say.

The most common side effects with Elmiron are headache, dizziness, and gastrointestinal events, such as diarrhea, nausea, abdominal pain, and rectal bleeding.

Detailed recommendations for the use of Elmiron will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the European Commission grants marketing authorization.

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