July 2005

HEALTHPOINT’s Spray Delivery System Recognized as a New Medical Technology by Novation

The spray delivery systems Accuzyme® Spray (Papain, Urea) and Panafil® Spray (Papain, Urea, Chlorophyllin Copper Complex Sodium) from HEALTHPOINT® (Fort Worth, Tex) have been recognized as new medical technologies by the Novation Wound Care Management Council (Irving, Tex).
Novation is the supply company of VHA Inc. and the University HealthSystem Consortium (UHC). Novation is committed to ensuring that VHA and UHC members have access to information about new and potentially innovative healthcare technology.
The Accuzyme Spray and Panafil Spray delivery systems give healthcare providers a dosage form that can be sprayed onto wounds without the use of applicators commonly used with comparable ointments. The spray delivery form avoids running or dripping and facilitates application onto the wound bed.
Upon application, a small percentage of patients may occasionally experience a slight stinging sensation when using Accuzyme Spray or Panafil Spray.
Visit http://www.healthpoint.com for more information.

Patients with Skin Infections Caused by MRSA Cured More Often with Zyvox®

The antibiotic Zyvox® (linezolid injection, tablets, and for oral suspension) from Pfizer (New York, NY) is more effective than vancomycin for the treatment of complicated skin and soft tissue infections (cSSTIs) caused by methicillin-resistant Staphylococcus aureus (MRSA), according to the largest MRSA cSSTIs study to date published in Antimicrobial Agents and Chemotherapy. Of the total study population, including those treated for methicillin-susceptible infections, the number of patients cured with Zyvox was comparable to those cured with vancomycin. In addition, patients taking Zyvox spent up to 5 fewer days on intravenous (IV) treatment because of its availability as a pill. While Zyvox is available in interchangeable IV and oral formulations, it is the only oral medicine approved by the US Food and Drug Administration (FDA) for MRSA infections.
This study involved 1,180 patients with cSSTIs, 361 of whom had confirmed MRSA infections. Patients in the microbiologically evaluable MRSA subgroup treated with Zyvox had better microbiologic cure rates: 88.6% for Zyvox patients versus 66.9% for vancomycin patients.
“In this study, Zyvox was shown to be better than traditional vancomycin therapy in improving outcomes for patients with serious MRSA infections,” said Dr. John Weigelt, lead investigator of the study and professor and vice chairman of the Department of Surgery at the Medical College of Wisconsin. “These data also reinforce the value of having a pill for patients, which may allow patients to leave the hospital sooner on oral therapy.”
Because of the oral availability of Zyvox, patients in the Zyvox arm had up to 5 fewer days on IV therapy than patients treated with vancomycin. More than half of study participants (52%) treated with Zyvox began treatment on the oral formulation. The US Centers for Disease Control and Prevention recommends removing catheters and using an IV only when essential, since these and other invasive devices are frequent causes of hospital-acquired infections.
Skin and soft tissue infection is a common cause of morbidity in the community and hospital. Those at risk for cSSTIs include surgical patients, patients with diabetes, and those who are immunocompromised, such as patients with cancer. Resistant bacteria, such as MRSA, increasingly cause these infections. According to a previous study, the rate of MRSA among cSSTI isolates is approximately 3%. Thirty years ago, only 2% of hospital-acquired Staphylococcus aureus infections in intensive care units were resistant to antibiotics, but today physicians are seeing rates of approximately 60%.
“The rapid emergence of MRSA is an increasing public health problem, especially among hospitalized patients where skin and soft tissue infections caused by MRSA can be fatal,” said Dr. Weigelt. “Zyvox has been shown to have excellent skin and tissue penetration, which I believe is important when treating complicated SSTIs to ensure the treatment reaches the infection site. Zyvox is a critical option for patients with risk factors for MRSA, such as an acute illness, a compromised immune system, or previous antibiotic use.”
In the intent-to-treat (ITT) population, Zyvox had clinical cure rates of 92.2% versus 88.5% for patients on vancomycin. In the MRSA subgroup (microbiologically evaluable population), patients treated with Zyvox had better microbiologic cure rates of 88.6% compared with 66.9% for patients on vancomycin. In the ITT population, patients in the Zyvox group had fewer days of IV therapy than those in the vancomycin group (4.0 ± 2.6 days vs. 9.0 ± 5.3 days, respectively). The overall mean treatment duration was significantly longer in the Zyvox group versus the vancomycin group (11.8 ± 4.9 days vs. 10.9 ± 5.3, respectively).
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Anodyne Therapy Receives Regulatory Approval from Health Canada for Treatment of Peripheral Neuropathy

Anodyne Therapy LLC (Tampa, Fla) announces that it has received regulatory approval from Health Canada to market its Anodyne Therapy Systems in Canada. Approved Canadian labeling, based on submission of published clinical studies, includes temporary reduction in disturbances in skin sensation, increases in balance, and reduction in fall risk (when used adjunctively with physical therapy) due to diabetic and other peripheral neuropathies.
Peripheral neuropathy is nerve damage associated with diabetes and other chronic conditions. Symptoms include numbness and/or pain in the feet, legs, and hands. Complications of this devastating condition are reported to cost the US healthcare system in excess of $37 billion annually and include wounds that do not heal for months or years, lower-extremity amputations, reduced mobility, and increased risk of falls. While drugs are sometimes effective for the pain associated with diabetic peripheral neuropathy, no drug or medical device had previously been shown to increase sensation or improve balance once it has been diminished or lost due to peripheral neuropathy.
Anodyne Therapy treatments are currently available nationwide at more than 3,200 outpatient therapy facilities, hospitals, nursing homes, physician offices, and home health agencies to improve functional outcomes for patients suffering from peripheral neuropathy, chronic pain, and a broad range of other health problems. Products are also available for convenient home use.
Visit http://www.anodynetherapy.com for more information.

Ortec Set to Initiate 60-Patient Confirmatory Trial for Venous Leg Ulcer Approval

Ortec International, Inc. announces that it has come to an agreement with the US Food and Drug Administration (FDA) on the parameters of a 60-patient confirmatory trial evaluating OrCel® in the treatment of venous ulcers and has submitted a final version of the study protocol to the FDA. Upon Ortec receiving formal approval of the clinical protocol from the FDA, Ortec will initiate patient enrollment upon completion of all the preliminary steps required to initiate the 8 clinical sites participating in the study. Patient enrollment is expected to begin at the end of July.
The confirmatory trial is being conducted by Ortec at the recommendation of the FDA based on its review of Ortec’s Pre-Market Approval (PMA) application. As previously announced, the FDA advised Ortec that it believed that the patients in which OrCel was shown to be statistically significant were not prospectively defined in Ortec’s protocol. Accordingly, the FDA recommended that an additional trial involving only patients with typical venous ulcers (tissue damage through the dermis but not into the underlying fascia) be conducted to confirm Ortec’s findings.
The clinical data from the 12-week pivotal trial submitted as part of Ortec’s PMA showed that in typical venous ulcers (those ulcers to be evaluated in the confirmatory trial), 59% of the OrCel-treated patients achieved wound closure versus 36% of the patients who received the standard of care treatment (p = 0.034) as well as a statistically significant differential in the rate of healing (p In a previous 36-patient, 12-week pilot study evaluating OrCel in the treatment of venous ulcers (using a non-frozen version of OrCel), OrCel performed similarly with 53% of the OrCel-treated patients achieving wound closure compared to 26% of the patients treated with the standard of care.
The protocol, clinical design, and statistical methodology have been reviewed extensively by the FDA to ensure that the data generated in the upcoming confirmatory trial will be combinable with the data from the pivotal trial.
Visit http://www.ortecinternational.com for more information.

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