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Italian Company May Revolutionize Bladder & IC Therapies

Physion develops technology to deliver medications directly into the bladder wall.

Wouldn't it be great of antibiotics could be delivered deep into the bladder wall for patients who have long term, chronic infections? If the bladder could be anesthetized locally so that patients could have a painfree hydrodistention in the doctors office? To put a bladder coating directly where it is needed the most?

Traditionally, bladder diseases were treated with an oral medication or intravesically with a medication placed directly into the bladder (via catheter). But, the ability of those medications to actually reach through the bladder wall and into deeper tissues is limited. Why? The bladder membrane is so tightly knit that it makes it difficult for most drugs to cross through the barrier. In fact, the human bladder is one of the most impermeable of all mammals on our planet. One exhibitor at the recent AUA conference, Physion (Italy), has a new technology which could revolutionize the way bladder diseases are treated.

EMDA (Electromotive Drug Administration) allows some drugs, via a painless electrical current, to be delivered directly across the bladder membrane and into the deeper tissues, without the side effects often seen with oral dosage. It is not yet approved for use here in the USA.

The ramifications for the urology community are quite exciting. UTI's may be treated easily with antibiotics delivered directly into the bladder wall, thus avoiding the nausea and related symptoms that often occur with long term, higher dose meds such as Augmentin. Anesthetics, such as lidocaine, can be delivered directly into the bladder wall thus reducing the pain patients may feel with various instillations or before procedures/biopsies. Bladder coatings, such as heparin, may be applied directly to the bladder thus reducing the need for daily home catheterizations.

Will it work? A new study released at this months AUA ("Pharmacokinetics and pharmacodynamics of Oxybutynin and N-Desethyl Oxybutynin Following Oxybutynin Administration By Oral And Intravestical Routes" - #1135) compares oxybutynin given orally, intravesically (passive diffusion) and via EMDA. The results demonstrated that EMDA provided the best therapeutic benefit of the three methods. Why? It appears to deliver a larger proportion of medication across the epithelium.

Robert L Stephen, MD, Chief Scientist for Physion, sat down with the ICN for a brief interview on this new drug delivery system.

Q: What types of diseases/functions do you see EMDA playing?

A: EMDA has a wide number of potential uses. We can use it as a local anesthetic to numb the bladder sufficiently for tumor removal without the side effects and inconvenience of general anesthesia. It has applications for use in chemotherapy for cancer of the bladder. We've also conducted some early studies with IC patients.

Q. Can you share how you've applied it to IC?

A: Our research is preliminary and was begun about two years ago in Germany. In Stage One, we use EMDA to deliver lidocaine and dexamethasone prior to hydrodistention.

Q: Why prior to a hydrodistention?

A: Many patients have trouble relaxing their detrusor muscle. We don't want to hydrodistend spasming muscles and painful bladders. The lidocaine relaxes the muscle, stops the spasms and renders the bladder wall pain-free.. The dexamethasone, we believe, wipes out inflammation.

Q: What is the second phase?

A: If a patient doesn't respond to the first, we'll use EMDA to deliver heparin into the bladder wall as a GAG layer replacement.

Q: What type of responses have you seen?

A: It's early yet but the initial results are promising, particularly for patients who are seriously ill - those who have not responded to other therapies.

Q: Does it hurt?

A: No, patients walk in and walk out of the office as soon as a treatment is completed.

Q: How is the FDA approval proceeding?

A: We've done all that they've asked so ar and we're now waiting to hear from them. Until that time, it is not available in the US.

For more information, please visit the Physion web site at: http://www.physion.it

Written by Jill Osborne, June 3, 2001 at AUA 2001.