Pentosan polysulfate sodium

422455006

New Medicines

Elmiron · Bladder pain syndrome (interstitial cystitis)

Information

Elmiron
New molecular entity
Consilient Health
Bayer

Development and Regulatory status

Launched
Launched
Launched
September 2018
Yes

Sep 18: Launched in UK. The price is £450.00 per pack of 90 capsules. [4]


Jun 17: Approved in EU through the centralised procedure - applicant is a German company, bene-Arzneimittel GmbH [3]


Apr 17: In the EU, Elmiron was designated as an orphan medicinal product Jan 15 for ´treatment of Interstitial Cystitis’. Following the CHMP positive opinion and at the time of the review of the orphan designation by the Committee on Orphan Medicinal Products (COMP), this product was withdrawn from the register of designated orphan medicinal products on request of the sponsor, and the indication was changed to ´the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition´ [3].


Mar 17: EU positive opinion for treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition [3].


May 97: Launched in US [2].

Category

A low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects. Taken three times a day.
Bladder pain syndrome affects 400,000 people in the UK, 90% of whom are women. The average age of people affected by bladder pain syndrome is 40 years old. In England in 2015/16 there were 8,542 hospital admissions with chronic interstitial cystitis, and 905 finished consultant episode bed days [1].
Bladder pain syndrome (interstitial cystitis)
Oral

Further information

Yes
September 2019

Trial or other data

2001: In a paper published in J Urol, treatment with oral pentosan polysulfate sodium (300-900 mg/day) caused responses (≥ 50% improvement in Patients´ Overall Rating of Improvement of Symptoms, PORIS, relative to baseline) in 19% of 380 women in a dosage comparison study after 4 weeks. Among the 230 patients who completed the 32-week study, responses were observed in 567.1, 59.5 and 60.1% of those given doses of 300, 600 and 900 mg/day, respectively. Only 14% had severe symptoms, compared with 35% of patients at baseline, and 4.5% discontinued treatment because of a lack of efficacy [2].

Evidence based evaluations

EPAR
NIHR