New Phase IV Clinical Study Indicates LidoSite(R) Provides Rheumatology Patients Superior Pain Relief
- Category: Small Molecules
- Published on Tuesday, 20 March 2007 02:00
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FAIR LAWN, NJ, USA | Mar 19, 2007 | Vyteris Holdings (Nevada), Inc. (OTCBB: VYHN), today announced results from a new phase IV "Open Label" clinical study demonstrating that LidoSite, the first FDA approved active patch for dermal analgesia, provided better pain relief to more than 73 percent of patients receiving injections of hyaluronic acid during treatment for osteoarthritis than usual topical analgesics.
"Treatment can be very painful, requiring multiple injections into sensitive joints, with many patients having a difficult time with this pain, leading some to avoid regular treatment," said Dr. Evan Liebowitz, a rheumatologist affiliated with Prospect Medical Office in Midland Park, NJ and Valley Hospital in Ridgewood, NJ. "Patients who avoid regular treatments for rheumatoid arthritis and osteoarthritis risk further loss of articular cartilage in the knee."
The study, involving six study sites and 14 physicians, followed 63 patients over the course of two routine injections of hyaluronic acid for the treatment of osteoarthritis.
During the first treatment, patients either received no local anesthesia or an alternate local anesthesia prior to cannulation or needle puncture. During the second treatment, patients received the LidoSite system, comprised of the LidoSite Patch and the LidoSite Controller. In the study more than 73 percent preferred LidoSite to the treatment used during their first visit. Additionally, the majority of rheumatology physicians surveyed were satisfied with LidoSite, compared to other available treatment options, such as ethyl chloride, lidocaine injections or fluormethane spray.
"This initial study demonstrates the acceptability among patients and rheumatologists for using LidoSite as an effective treatment regime for needle pain for the multiple injections arthritis requires, as well as its potential availability in the doctor's office setting." said Timothy J. McIntyre, president and chief executive officer of Vyteris. "The results of this clinical study should be good news to the growing number of patients experiencing rheumatoid arthritis and whose therapy involves painful injections."
In the study more than half the rheumatology physicians surveyed found LidoSite exceeded their expectations with regard to positively impacting their patient's experience. Overall, the majority of physicians in the study were satisfied with the LidoSite Topical System in its ease of use and conformity to standard office practices.
"Our experiences with LidoSite demonstrated how it can effectively address patients' needs who have to deal with the pain of these injections," Liebowitz said. "The nature of the treatments involving multiple injections means we can offer a broader range of solutions for those patients who may not seek treatment because of the severity of the associated pain."
Unlike topical anesthetic creams typically used in today's healthcare settings to address needlestick pain, the LidoSite System delivers numbing medication to the procedure site quickly and effectively after a 10 minute application. Topical anesthetic creams usually take up to an hour for full anesthetic benefit.
"LidoSite significantly minimized the pain I was feeling when I received knee injections of hyaluronic acid," said Richard Besser, a patient enrolled in the study. "I have to get injections every six months to treat my osteoarthritis with the pain often more than I care to experience, but using LidoSite has been a tremendous benefit to me and I'm sure to other arthritic patients."
The American Pain Society (APS) and the American Academy of Pediatrics (AAP) set forth guidelines for adequately addressing acute - or short-lived - pain. These guidelines, which apply to the treatment of children and adults, call for healthcare practitioners to eliminate or reduce pain caused by medical treatments whenever possible. In fact, the APS and AAP agree that acute pain experienced with medical procedures can, in most cases, be substantially reduced and even prevented.
The use of iontophoresis to deal with pain associated with skin punctures (e.g. injections, blood draws etc) is supported by the Blue Cross/Blue Shield Technical Evaluation Center, indicating that "use of iontophoresis to administer local anesthetic before skin puncture or dermal procedures meets the TEC criteria."(1) Various Blue Cross/Blue Shield plans, providing care to over 50 million Americans, have issued a medical policy to its thousands of physician providers supporting the TEC findings and indicating "iontophoresis may be considered medically necessary to administer local anesthesia prior to venipuncture or dermal procedures."(2)
About the Clinical Study
On behalf of Vyteris, the clinical study was conducted by INC Research, a therapeutically focused contract research organization with an unrivaled reputation for conducting global clinical development programs including a complete range of customized Phase 1 - Phase 4 programs in therapeutic areas of specialty, and in innovative pediatric trials. INC Research is headquartered in Raleigh, North Carolina, and in 22 locations in 35 countries worldwide. For more information, please visit www.incresearch.com.
About Vyteris, Inc.
Vyteris, Inc., a wholly owned subsidiary of Vyteris Holdings (Nevada), Inc. (OTCBB: VYHN), are the makers of the first active drug delivery patch to receive marketing clearance from the U.S. Food and Drug Administration (FDA). Vyteris' proprietary active transdermal drug delivery (iontophoresis) technology delivers drugs comfortably through the skin using low-level electrical energy. This active patch technology allows precise dosing, giving physicians and patients control in the rate, dosage and pattern of drug delivery that can result in considerable therapeutic, economical, and lifestyle advantages over existing methods of drug administration. Vyteris' first product, LidoSite(R), which provides dermal analgesia prior to venipuncture (IV catheter insertions, blood draws, etc.) and superficial dermatological procedures, was the first FDA approved active patch. Vyteris has also successfully demonstrated in-vivo, either in animals or in humans, the ability of their active patch technology to deliver drugs transdermally for the following applications: smoking cessation, anti-aging cosmeceuticals, treatments for Parkinson's disease, and peptides for various indications.
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "anticipate," "intend," "plan," "may," "will," "could," "would," "should," "believes," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, statements concerning the potential benefits of LidoSite, and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others, the uncertainty of regulatory approvals, potential lack of commercial acceptance of LidoSite by physicians and patients, and the competitive environment in the companies' industries. The company has described other important risks and uncertainties under the caption "Risk Factors" in its most recent Quarterly Report on Form 10-QSB and in various filings made with the SEC. Actual results may differ materially from those contained in the forward-looking statements in this press release. Please visit the company website at www.vyteris.com.
(1) Blue Cross Blue Shield Association. Technology Evaluation Center (TEC) Iontopheresis for Medical Indications. Assessment Program, Volume 18, No. 3. June 2003. Available at http://www.bcbs.com/tec/vol18/18_03.html.
(2) http://medpolicy.unicare.com/policies/guidelines/MED/ iontophoresis.html (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)
SOURCE: Vyteris Holdings (Nevada), Inc.