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Elmiron Approved by US FDA

Editors Note: The announcement of new treatments for IC is met with excitement, enthuasiasm and appropriate caution by both patients and physicians. With the long awaited approval of Elmiron as an oral medication for IC, this marks a historic event in the history of IC. Though Elmiron is not a cure for IC, it's effectiveness as a protective bladder coating must be substantial enough to meet FDA testing guidelines. Thankfully, we the IC patients, are now given another treatment option to explore with our physicians and that, I believe, is the ultimate success in new treatment announcements. As a support group leader, I'm often faced with patients who give up, who don't try new things and often suffer in silence in their homes. It is my hope that this announcement will encourage patients to re-engage in a dialogue with their physicians about treatments! The research is popping and we have every reason to be hopeful!

ELMIRON APPROVED BY FDA

NEW YORK, September 30, 1996 -- The Interstitial Cystitis Association is very happy to announce that the IVAX Corporation received final approval from the U.S. Food and Drug Administration to market the oral drug Elmiron (pentosan polysulfate sodium) for the relief of IC pain or discomfort. The drug will be marketed under the label of IVAX' subsidiary, Baker Norton Pharmaceuticals, Inc. This is the first time that an oral drug has been approved specifically for IC, and only the second drug approved for the disease (DMSO, the first to be approved, is instilled directly into the bladder).

Shipment to pharmacies will begin immediately. This is a significant advancement in the treatment options for interstitial cystitis. Although Elmiron was approved for marketing in Canada in 1993, it has, until now, only been available in the United States on a compassionate use basis. The ICA thanks IVAX for believing in Elmiron, and all IC patients who participated in the clinical trials.

IC patients and others looking for additional information on IC, its symptoms, Elmiron, and other available treatments may contact the Interstitial Cystitis Association (ICA) at P.O. Box 1553, Madison Square Station, New York, NY 10159, 1-800-HELP-ICA, (212) 979-6057 or our World Wide Web site at http://www.ichelp.com. For information on Elmiron, contact Baker Norton Pharmaceuticals, Inc., by telephone at 1-888-ELMIRON or by mail at Baker Norton Pharmaceuticals, Inc., 4400 Biscayne Blvd., Miami, FL 33137.

Elmiron FAQ (Frequently Asked Questions)

What is Elmiron? Elmiron (pentosan polysulfate sodium) functions as a synthetic, protective bladder coating.. which is believed to protect and/or restore a damaged, thin, or "leaky" bladder surface. In method of action, it falls in a similiar category to the natural protective coating of hyaluronic acid (Cystitat) now being developed and tested by Bioniche in Canada. Cystitat is in the very early stages of research and is not FDA approved.

Is Elmiron now available? Elmiron is now being shipped to pharmacies across the United States and is available by prescription only. If your physician or pharmacist is having trouble locating Elmiron, they may contact the company directly at the phone listed in the press release.

What do the research results say about Elmiron and it's effectiveness? Unfortunately, we don't have the published research results. However, the ICA was recently quoted as saying "Several clinical trials found Elmiron to significantly decrease IC pain in 38 percent of patients. This drug is recommended if pain is a significant IC symptom. These studies found that patients who responded to Elmiron tended to have remissions of symptoms."

Is it true that some patients can lose their hair while taking Elmiron? Yes, in the past few weeks, some patients on the Internet have reported hair loss. They were assured by the company that this only effected 4% of the patient population in trials and that the effects were reversible when the treatment was finished.

Does Elmiron have any interactions with other IC treatments? Research has not demonstrated any negative interactions and some patients use Elmiron in conjunction with other treatments.

Is Elmiron expensive? Unfortunately, Elmiron is not inexpensive. It can cost $160 for a one month supply.

How can I gather more information on Elmiron for my physician? Baker Norton Pharmaceuticals, a division of the IVAX Corporation, has a hotline for questions and information. You or your physician may contact them at: 1-888-ELMIRON.

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