ELMIRON (pentosan polysulfate sodium or PPS)

Low actual benefit in bladder pain syndrome in adults but no clinical benefit demonstrated in the management of this syndrome

• ELMIRON has Marketing Authorisation in 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. It is a rare chronic disease, with symptoms that can affect activities of daily living and impair patient’s quality of life.
• Clinical efficacy data, by comparison with placebo, have a low level of evidence, with a duration between 3 and 6 months of treatment.  The quantity of effect is modest at best in terms of overall improvement of the symptoms in about one-third of patients. The effect on each of the symptoms (namely pain, pollakiuria, urgency and nocturia) is not properly established.
• Given these limitations, the impact on the quality of life has not been established to date.