Printer Friendly

NEW USE FOR ZOVIRAX(R) PROVIDES EFFECTIVE ORAL THERAPY FOR THE TREATMENT OF CHICKENPOX

 NEW USE FOR ZOVIRAX(R) PROVIDES EFFECTIVE
 ORAL THERAPY FOR THE TREATMENT OF CHICKENPOX
 RESEARCH TRIANGLE PARK, N.C., Feb. 28 /PRNewswire/ -- The U.S. Food and Drug Administration has approved a supplemental New Drug Application, submitted by Burroughs Wellcome Co., to support the use of Zovirax(R) brand acyclovir for the acute treatment of varicella, more commonly known as chickenpox.
 One of the most common infectious diseases in children, chickenpox is a viral condition that affects approximately 3.5 million Americans each year. Zovirax is the first effective oral antiviral therapy to be made available for the treatment of chickenpox in otherwise healthy children.
 "Anyone who has had chickenpox or has cared for a child with chickenpox knows that supportive measures for itching only go so far," said Dr. Sandra Nusinoff-Lehrman, head of the department of infectious diseases and immunology at Burroughs Wellcome Co. "With Zovirax, physicians will be able to prescribe specific oral antiviral therapy to reduce the severity and duration of this disease."
 Chickenpox is caused by the varicella-zoster virus, which is one member of
the herpes family of viruses. Ninety percent of chickenpox cases occur before age 15, which is fortunate since adolescents and adults usually have a more severe outbreak of chickenpox. Symptoms of chickenpox include fever, malaise and a characteristic rash that goes through several stages, changing from initial red blotches to tiny fluid-filled blisters (vesicles) and then crusting. Most of the rash crusts within six or seven days without treatment.
 Varicella-zoster virus is believed to be spread mainly by airborne droplets that infect individuals by coming in contact with the nose, throat or eyes. When one child in a family catches the virus, there is an 80 to 90 percent chance that brothers and sisters, as well as other members of the household who have not been infected previously, will also contract the disease. Symptoms are generally more severe in these secondary cases. Children who get chickenpox usually do not get it again, but the virus can re-emerge, most frequently in adulthood, and cause shingles, a painful nerve inflammation and rash.
 Although chickenpox is generally not dangerous in otherwise healthy children, complications can include bacterial infections, pneumonia, and various neurologic syndromes. More than 4,500 normal children are hospitalized each year in the United States because of the disease. Approximately 1 in 50,000 normal children with chickenpox die.
 The oral formulations of Zovirax are a banana-flavored suspension (liquid), a 200 mg capsule and an 800 mg tablet. The recommended dosage for children ages 2-12 is 20 mg per kilogram of body weight (maximum of 800 mg per dose) four times daily (80 mg/kg/day) for five days. Recommended dosage for adolescents ages 13-18 is 800 mg four times daily for five days. Therapy should be initiated at the earliest sign or symptom. Cost of therapy will be $30-55, depending on the age and weight of the child.
 Studies Support Use
 Zovirax was studied as a treatment for chickenpox in children with normal immunity in a clinical trial program that began in 1987. All studies were double-blind and placebo-controlled and therapy was started within 24 hours after the rash was noticed.
 In one study of 815 patients ages 2-12 years, patients receiving Zovirax Suspension had fewer chickenpox lesions, a shorter duration of new lesion formation, reduced itching, earlier evidence of healing and fewer residual lesions a month after being sick. Children treated with Zovirax began to feel better sooner than those receiving placebo, with most signs and symptoms showing improvement by the second day of treatment. Therapy with Zovirax also reduced the proportion of patients with fever (temperatures over 100 degrees) and other symptoms such as fatigue and loss of appetite.
 The drug showed similar results in a separate study of 68 adolescent patients (ages 13-18 years). Patients receiving drug treatment were administered Zovirax at 800 mg four times daily for five days within 24 hours of developing a rash. These patients experienced a shortened course of disease, a significant reduction in fever and fewer residual lesions.
 The most frequent adverse events reported in the varicella clinical trials with Zovirax were diarrhea, abdominal pain, rash, vomiting and flatulence. These events were also reported in a similar proportion of placebo recipients. Adverse experience reports in the varicella trials were consistent with many pre- and post-marketing studies of Zovirax for other indications. Therapy with Zovirax did not affect antibody response to varicella.
 Antiviral Therapy
 Until recently, physicians had little specific therapy to offer people suffering from chickenpox. Treatment was directed at the temporary relief of symptoms, such as acetaminophen to help reduce fever, and topical and oral medications for the relief of itching. Aspirin should be avoided because of the risk of Reye's syndrome.
 Zovirax works by selectively blocking the replication of the varicella-zoster virus. When activated in infected cells, the drug inhibits the virus from multiplying, which arrests the disease progress. The product of more than 15 years of research, Zovirax was developed as part of Burroughs Wellcome's antiviral research program.
 In 1982, Burroughs Wellcome Co. introduced Zovirax Ointment, the first drug released for marketing in the United States to treat initial episodes of genital herpes. Zovirax Capsules were introduced in 1985 for treatment of primary genital herpes and for treatment and suppression of recurrent disease. In 1990, the indications for Zovirax were expanded to include treatment of herpes zoster (shingles) with oral and I.V. preparations and I.V. therapy for herpes simplex encephalitis, a life-threatening infection of the central nervous system. Zovirax Suspension was introduced in 1989, and 800 mg tablets became available in 1991.
 Burroughs Wellcome is a research-based pharmaceutical company with headquarters in Research Triangle Park, N.C. The company is a wholly owned subsidiary of the Wellcome Foundation Ltd., an international pharmaceutical firm based in London, England. Last year Wellcome devoted approximately 38 percent of its more than $400 million research and development effort to the study of antiviral and infectious diseases.
 -0- 2/28/92
 EDITOR'S NOTES:
 (1) FULL PRESCRIBING INFORMATION IS AVAILABLE UPON REQUEST.
 (2) PRESS BRIEFING -- ATTENTION BROADCAST MEDIA:
 The press conference will be aired live via satellite at 10:00 a.m.
 EST, followed by transmission of a B-roll package. This information
 will be rebroadcast at 1:00 p.m. EST on the same coordinates.
 Satellite Coordinate
 KU Band: Spacenet 2 C Band: Galaxy 6
 Transponder 24 (Old Westar 4 location)
 Audio subcarriers 6.2/6.8 Transponder 17
 Audio subcarriers 6.2/6.8
 /CONTACT: Kathy Bartlett, 919-248-4302, Sharon Bickus, 919-248-8611, or Karen Collins, 919-248-3231, all of Burroughs Wellcome Company/ CO: Burroughs Wellcome Company ST: North Carolina IN: MTC SU: PDT


CM-JZ -- CH001 -- 3627 02/28/92 10:02 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Feb 28, 1992
Words:1117
Previous Article:ESPRIT ANNOUNCES FRITZ AMMANN AS CEO
Next Article:GM EXECUTIVES VISIT WSU CAMPUS, CRITIQUE STUDENTS' DESIGNS FOR 2005 ACHIEVA
Topics:


Related Articles
STERLING WINTHROP RESPONDS TO INACCURATE MILRINONE REPORTS
DIFLUCAN (FLUCANAZOLE) DEMONSTRATES SUPERIOR EFFICACY TO AMPHOTERICIN B IN PREVENTING RELAPSE OF AIDS-RELATED CRYPTOCOCCAL MENINGITIS
NEW WELLCOME ANTIVIRAL COMPOUND SHOWS PROMISE AS ANTI-HIV AGENT
FAMVIR SIGNIFICANTLY REDUCES PAIN OF 'SHINGLES' SUFFERERS; NEW STUDY PROMISES HOPE FOR UNMET CHALLENGE OF COMMON VIRAL DISEASE
STUDY PUBLISHED IN NEW ENGLAND JOURNAL FINDS ORAL CYTOVENE AN EFFECTIVE ALTERNATIVE TO I.V. FOR SIGHT-THREATENING AIDS INFECTION
LIDAK PHARMACEUTICALS REPORTS POSITIVE RESULTS FROM PHASE 3 EUROPEAN CLINICAL TRIAL
LIDAK RESPONDS TO QUESTIONS REGARDING POSITIVE PHASE 3 CLINICAL TRIAL ANNOUNCEMENT
NEW THERAPY FOR RECURRENT GENITAL HERPES CLEARED BY FDA VALTREX NOW AVAILABLE
FDA Clears SPORANOX(R) Oral Solution for Oral and Esophageal Fungal Infections
Doctors Expect Oral Therapies To Dramatically Expand Erectile Dysfunction (ED) Market

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters