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Drugs Approved by the FDA

Drug Name: Elmiron (pentosan polysulfate sodium)

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: IVAX
Approval Status: Approved October 1996
Treatment for: interstitial cystitis

General Information

Elmiron has been approved as a treatment for the relief of pain and discomfort associated with interstitial cystitis (IC), a chronic, progressive and debilitating urinary bladder disease afflicting primarily women. IC is characterized by severe bladder and pelvic pain and urinary frequency.

Patients take one 100 mg capsule three times per day. Relief from the symptoms of IC sometimes takes as long as three months to occur, and subjects must remain on Elmiron for continuing benefit.

Additional Information

IC is a painful inflammatory disease of the urinary bladder with symptoms similar to those of a severe bladder infection. Unlike common bladder infections, however, IC is not diagnosed by positive urine cultures, and symptoms do not respond to antibiotics. Definitive diagnosis may require a biopsy taken during cytoscopy, making IC cumbersome to readily diagnose. For this and other reasons, IC has been significantly overlooked, misunderstood, and underdiagnosed.

In addition to the pain associated with the disease, urinary frequency sometimes exceeds 60 voidings per day. Not surprisingly, IC confines many sufferers to their homes, and at times leads to clinical depression. The pain, frequency of urination, isolation, and sleep deprivation make it difficult for an IC sufferer to function in a work environment or to maintain a normal family life.

Currently, the most common means to treat IC include bladder distention requiring general anesthesia, diet modification, and the use of dimethyl sulfoxide (DMSO) requiring painful administration by catheter. Although bladder distention and DMSO treatment may provide temporary relief of IC symptoms, the symptoms usually reappear, requiring additional invasive treatments.


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Drug listing last updated on June 20, 2008

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