Home » Drug Information » FDA-Approved Drugs » 1996
Medical Areas: Nephrology/Urology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Drug Name: Elmiron (pentosan polysulfate sodium)
Company: IVAX
Approval Status: Approved October 1996
Treatment Area: 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.