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Iomed Outlines Plans for New Local Inflammation, Ocular and Pain Drug Delivery Systems.


SALT LAKE CITY, Utah--(BW HealthWire)--March 16, 1999--IOMED, Inc. (AMEX AMEX

See: American Stock Exchange
:IOX IOX Iomed, Inc. (stock symbol) ) today outlined plans for the development of systems for the iontophoretic delivery of drugs to treat acute local inflammation, for the treatment of ocular disease and for systemic pain control.

Local Inflammation

IOMED recently reached agreement with the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) to initiate Phase III clinical studies for a new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) to obtain general labeling for the iontophoretic delivery of dexamethasone dexamethasone /dex·a·meth·a·sone/ (dek?sah-meth´ah-son) a synthetic glucocorticoid used primarily as an antiinflammatory in various conditions, including collagen diseases and allergic states; it is the basis of a screening test in the . The studies will use IOMED's proprietary iontophoretic drug delivery technologies to administer a formulation of dexamethasone sodium phosphate dexamethasone sodium phosphate

Pharmacologic class: Glucocorticoid

Therapeutic class: Anti-inflammatory

Pregnancy risk category C

Action



Unclear.
 for the treatment of acute local inflammatory conditions such as epicondylitis ep·i·con·dy·li·tis
n.
Infection or inflammation of an epicondyle.


Epicondylitis
A painful and sometimes disabling inflammation of the muscle and surrounding tissues of the elbow caused by repeated stress and strain
 (tennis and golfers' elbow) and other non-specific tendonitis tendonitis /ten·do·ni·tis/ (ten?do-ni´tis) tendinitis.

ten·do·ni·tis
n.
Variant of tendinitis.
. Pending clinical site selection and identification of a marketing partner, studies are expected to begin in early fiscal 2000.

The studies will be conducted using IOMED's iontophoretic drug delivery systems and upon initiation are expected to last approximately nine months. In conjunction with a marketing partner, the Company intends to market the approved system under the brand name Iontodex(TM) to a broad audience of primary care physicians.

IOMED expects to offer Iontodex to physicians and patients in an integrated, easy to use second-generation iontophoretic drug delivery system. The system will feature a pack comprised of six single-use drug delivery patches and one re-usable dose controller specifically programmed to deliver six doses of medication, and will be available by prescription through traditional wholesaler and pharmacy distribution channels.

"Leading physical therapists and sports medicine sports medicine, branch of medicine concerned with physical fitness and with the treatment and prevention of injuries and other disorders related to sports. Knee, leg, back, and shoulder injuries; stiffness and pain in joints; tendinitis; "tennis elbow"; and  physicians have been using our systems for the iontophoretic delivery of dexamethasone for years. However, an approved NDA resulting from these studies will allow us to more aggressively promote the product and broaden our market reach into the $5 billion anti-inflammatory drug market, which is dominated by branded non-steroidal anti-inflammatory drugs Non-steroidal anti-inflammatory drugs (NSAIDs)
Aspirin, ibuprofen, naproxen, and many others.

Mentioned in: Mastocytosis
 (NSAIDs), including the recently introduced COX-2 inhibitors Cox-2 Inhibitors Definition

Cox-2 inhibitors are non-steroidal anti-inflammatory drugs (NSAIDs) which selectively inhibit cyclooxygenase-2. The cyclooxygenases are required for the creation of prostaglandins.
," commented Steven Hamilton, Vice President for Business Development. "By combining the superb anti-inflammatory effects of dexamethasone with the safety profile of our delivery system and method, we believe our product holds the potential to offer superior safety and superior efficacy compared with existing treatment alternatives, which involve systemic dosing and a high incidence of gastrointestinal irritation." IOMED's goal is to obtain drug labeling for Iontodex that will allow penetration of this market by selling to primary care physicians, orthopedists, emergency room physicians and other medical professionals.

Ocular Delivery

IOMED is also refining prototype systems for the iontophoretic delivery of therapeutics into the eye. In in-vivo studies conducted in rabbits, the Company has been successful in demonstrating the delivery of small molecules, oligonucleotides, peptides, proteins and genes through the sclera sclera: see eye.  (white of the eye) and into the retina. IOMED is currently screening anti-angiogenic compounds, which would prevent the proliferation of new blood vessels Blood vessels

Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names.
 in the eye, for the treatment of age-related macular degeneration Age-related macular degeneration (ARMD)
Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60.
 and diabetic retinopathy diabetic retinopathy
n.
Retinal changes occurring in long-term diabetes and characterized by punctate hemorrhages, microaneurysms, and sharply defined waxy exudates.
. Both diseases, which affect the retina, are common causes of blindness and there are no approved drug therapies for the treatment of either disease. "The need to use needle injections to get many drug candidates into the eye significantly inhibits the ability to conduct effective clinical trials in the treatment of these and other diseases of the eye," stated Mr. Hamilton. "We believe that a safe and effective iontophoretic drug delivery platform could offer the pharmaceutical industry a rapid, non-invasive alternative for the delivery of therapeutics to the eye without the risk of infection, bleeding, retinal detachment or retinal tissue damage".

Pain Control

The Company also plans to complete the development of its iontophoretic delivery system for the delivery of hydromorphone for the treatment of acute post-operative pain and for the control of chronic pain. This system is at a Phase IIb clinical stage, and the Company is seeking a development and marketing partner to move forward with the development of this value-added application of its technology. "Given the high costs of clinical trials, and the highly competitive nature of this market, a strong development and marketing partner is critical to further the development of this system," noted Mr. Hamilton. "However," Mr. Hamilton continued, "our effort is supported by a belief that an iontophoretic system for the delivery of hydromorphone could provide a level of safety, efficacy, control and convenience that would surpass all other established drug and delivery system combinations currently on the market."

IOMED, Inc. is a leader in the advanced research, development and manufacture of iontophoretic drug delivery systems, which are marketed to healthcare providers worldwide. Iontophoretic drug delivery involves the transport of water-soluble ionic drugs into and through the skin or other tissue using a mild electrical current. IOMED's World Wide Web site is at www.iomed.com.

The statements contained in this release that are not purely historical are forward-looking statements, as defined in section 21E of the Securities and Exchange Act of 1934, and include IOMED's beliefs, expectations or intentions regarding its future operations and financial condition. All forward-looking statements included in this release are made as of the date hereof and are based upon information available to IOMED as of such date. IOMED assumes no obligation to update any forward-looking statement. It is important to note that actual outcomes could differ materially from those in such forward-looking statements. Readers should also refer to the risk factors and other disclosures set forth in IOMED's filings with the Securities and Exchange Commission on Forms S-1 and 10-K.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Mar 16, 1999
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