ViraDerm®   

Topical treatment for Cold Sores

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ViraDerm

The Herpes Virus

Clinical Studies

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The Herpes Simplex Virus   

ViraDerm Treatments

 

ViraDERM, by Empire Pharmaceutical Inc., is a patented, nonprescription topical preparation marketed for the treatment of herpes-induced cold sores. Its ingredients, stannous fluoride and glycerin, are "Generally Recognized as Safe and Effective" (GRASE) for application to the oral cavity by the U.S. Food and Drug Administration. The subject of an FDA-granted "Investigational New Drug Application" (IND), VIRADERM was tested in a controlled clinical trial where it outperformed placebo by its ability to shorten healing time and prevent new lesions from forming. Rigorous in vitro testing by a prestigious virology laboratory showed that VIRADERM may be directly virucidal and unlikely to induce drug resistance. Intriguing accounts from practitioners and patients who have used VIRADERM for herpes infections other than cold sores, have lead to clinical investigations for these conditions.

Herpes Virus Groups

 

Herpes is a virus that causes non-curable infections with symptoms ranging from embarrassing to painful and debilitating.  The term "herpes" derives from an ancient Greek word meaning, "to creep, or crawl".  Three types of infections are caused by the virus: the Herpes simplex virus (HSV-1) gives rise to cold sores around the mouth and nose; virtually the same virus, called Herpes simplex-2 (HSV-2), causes Genital Herpes; and the Herpes zoster Varicells virus (HZV) is responsible for Chickenpox and shingles.   Viruses injure tissue when they reproduce, or replicate, commandeering the reproductive machinery of the host cell. Each form of herpes replicates in the same way.

The infections are not curable, sometimes hiding for years in the body’s nerve cells (facial nerve cells-HSV-1, near the spinal column-HSV-2) as a dormant or latent ailment when not active. "Outbreaks" are stimulated by factors such as stress, reactions to drugs, intense sunlight, fever or trauma.

HSV-1 and HSV-2 are contagious, passing from one person to another-the first by kissing and the latter by sexual contact.  HZV, while not communicable as shingles, is transmitted as Chickenpox.

Physicians and healthcare professionals diagnose and treat both Genital Herpes-HSV II and Shingles-HZV. 

Genital herpes is a sexually transmitted disease (STD).  Present as rupturing blisters in its most virulent phase, it is highly contagious, often painful, and may be accompanied by flu-like symptoms. The disease causes difficulty in sexual relations and frequently leads to psychological distress.  Those infected typically suffer four or five outbreaks a year.  The sores take between 2 to 4 weeks to heal.  The disease causes complications in pregnancy and potentially fatal infections in babies.

Shingles is the most painful , and possibly the most disfiguring of the herpes diseases.  The HZV infection results in a widespread rash, replete with blisters and crusting, often appearing on the face.  The pain can be so severe that it may be mistaken for pleurisy, kidney stones, gallstones, appendicitis, or even a heart attack, depending on the location of the affected nerve.  High dose prescription oral antiviral agents are the treatment of choice, though they serve only to shorten the course of an episode--provided therapy is started within 48 hours of the first symptoms.  Other than steroids and other external analgesics to alleviate symptoms, there is no topical treatment for shingles.

 Herpes Simplex-1 (cold sores) is a self- treatable condition, therefore less likely to be seen by clinicians. From the first sign of an outbreak – a tingling on the lip – to full bloom with a very red, somewhat painful and often ulcerative nodule, the outbreak usually lasts 7-10 days. Many times, sufferers don’t even get to doctors until the disease has passed its peak – with nothing left to resolve the infection but time.  The topical antiviral medicines are only marginally effective--shortening healing times by no more than 12 hours.  They remain available by prescription solely for their propensity to elicit viral resistance, a public health concern.

ViraDerm Treatments

ViraDerm is a product with documented activity against HSV-1. It relieves symptoms and cuts lesion resolution time without requiring a prescription or physician office visit. The product is remarkably safe with a long, successful history of use among millions of patients and decades of use in the dental care category. ViraDerm employs a patent protected formulation of stannous fluoride that appears to prevent viral attachment, stopping the herpes virus from penetrating the cell in the first place. With the virus no longer able to replicate, cold sore outbreaks are minimized and healing time reduced.  By applying ViraDerm at the "prodromal" or the pre-cold sore tingling phase of a herpes outbreak, many users have reported no lesions at all.

ViraDerm has been sold in Florida under the aegis of the Florida Department of Health.

A clinical trial performed to FDA guidelines confirmed the effectiveness of ViraDerm against HSV-1. It showed both fewer and less severe cold sore lesions, and anticipated outbreaks that did not occur. Large scale trials are underway to support new, stronger claims and indications than currently approved.

ViraDerm offers additional therapeutic potential than its standard OTC drug designation, FEVER BLISTER/COLD SORE TREATMENT, may imply. Recent scientific evidence suggests that ViraDerm attacks the herpes virus directly, adding an outright curative property to its benefit of symptomatic relief. By virtue of its unique ionic properties, ViraDerm appears to prevent the herpes virus from penetrating the host cell, thus (arresting) breaking the organism’s natural cycle at its most destructive stage, long before tissue damage takes place.  Moreover, ViraDerm’s putative mechanism of action would seem to apply to all three strains of herpes simplex: HSV-1, HSV-2, and HZV.

For this reason ViraDerm is being made available exclusively to Department of Defense practitioners interested in participating in open-label studies of ViraDerm in the three common herpetic conditions: Cold Sores, Genital Herpes, and Shingles.  The product – ViraDerm – is available exclusively to Department of Defense personnel as a viable treatment for HSV-1 infections (cold sores) worldwide. This limited availability is offered while the product is further tested for new claims and indications.

To order ViraDerm please fill out the enclosed order form. For additional information, please email your request to: info@usamediainc.com.

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