IVAX' Cystitis Drug Set For US Clearance

IVAX Corp has received an approvable letter from the US Food and Drug Administration for Elmiron (pentosan polysulfate sodium), the company's oral treatment for interstitial cystitis. If approved fully, Elmiron will represent the first effective oral treatment for the relief of pain and discomfort associated with the condition, and also the first non-generic approval for IVAX.

In order to gain approval, IVAX has been asked to provide certain data to address FDA questions concerning labeling and package inserts, and has committed to carrying out Phase IV studies after the drug has been launched. No other clinical trials are required, according to the FDA.

Interstitial cystitis is a painful inflammatory disease of the urinary bladder with symptoms similar to a severe bladder infection. In addition to the pain, urinary frequency is vastly increased (sufferers often need to urinate more than 60 times a day). Currently, interstitial cystitis is mostly treated using bladder distension (requiring general anesthesia) or dimethyl sulfoxide administered via catheter, but these treatments are invasive and provide only temporary relief from symptoms.