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ZOVIRAX(R) BENEFITS HEALTHY CHILDREN WITH CHICKENPOX

 ZOVIRAX(R) BENEFITS HEALTHY CHILDREN WITH CHICKENPOX
 RESEARCH TRIANGLE PARK, N.C., Nov. 28 /PRNewswire/ -- The antiviral medication Zovirax(R) brand acyclovir effectively reduced the duration and severity of chickenpox in healthy children, according to an article published in the Nov. 28, 1991 issue of The New England Journal of Medicine.
 These results were demonstrated in a placebo-controlled study, conducted at 10 medical centers throughout the country, which enrolled 815 children ages 2-12 who were treated within the first 24 hours of a chickenpox rash.
 Study Results
 In the study reported in The New England Journal of Medicine, patients receiving Zovirax had fewer chickenpox lesions, a shorter time of new lesion formation, reduced itching, earlier evidence of healing and fewer residual lesions. Therapy with Zovirax also reduced fever and other symptoms such as loss of appetite and tiredness.
 "It is clear that the effect of acyclovir treatment of chickenpox is a uniform reduction in the duration and severity of the disease," the authors said. "Nearly all the children treated with acyclovir had a mild illness of 3-4 days duration, typical of the disease that is commonly described.
 "That untreated chickenpox is not completely benign was underscored by the fact that 20 percent of the children given placebo had a prolonged illness, with progressive cutaneous disease persisting for more than six days," they said.
 Adverse events were infrequent and not statistically different among patients treated with placebo or Zovirax. Therapy with Zovirax did not affect antibody response to the varicella-zoster virus. The authors said it was unlikely that the short course of therapy would have any effect on the development of acyclovir resistance.
 Status of Therapy
 Treatment of chickenpox is not a labeled use for Zovirax. The Food and Drug Administration's Antiviral Drug Advisory Committee met on Nov. 12, 1991 to consider this study and other data. The committee found the data were sufficient for the FDA label for Zovirax to be expanded to include the use of the drug for the treatment of chickenpox in otherwise healthy children and adolescents 2-18 years of age. During the committee's deliberations it was noted that there was an approximately one day improvement in the duration of various disease measures in the group treated with Zovirax.
 The committee's findings, while not binding on the FDA, will be part of the considerations in reviewing the supplemental new drug application (NDA) for Zovirax submitted by Burroughs Wellcome Co., a research-based pharmaceutical company headquartered in Research Triangle Park, N.C.
 Chickenpox in the United States
 Approximately 3.5 million cases of chickenpox occur each year in the United States. Chickenpox is caused by varicella-zoster virus, a member of the herpes family of viruses. It usually occurs in early childhood, and symptoms include rash, fever, loss of appetite and tiredness.
 Complications are rare but 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 chickenpox. Approximately 1 in 50,000 die.
 Study Locations
 The chickenpox study, sponsored by Burroughs Wellcome Co., was conducted at 10 institutions in the United States. Study centers were: Stamford University Medical Center, St. Louis University, University of Alabama at Birmingham, University of Colorado, University of Connecticut Health Center, University of Mississippi, Columbia University, Baylor College of Medicine, University of Virginia Health Sciences Center, and University of Minnesota.
 Zovirax(R) as an Antiviral
 Zovirax(R) 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 initial 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. Zovirax Suspension was introduced in 1989, and an 800 mg tablet became available in 1991.
 Burroughs Wellcome Co. is a wholly owned subsidiary of The Wellcome Foundation Ltd. (Wellcome plc) of London. Wellcome has a 110-year heritage of commitment to the improvement of human health through innovative medicines for poorly understood or inadequately treated diseases.
 -0- 11/28/91
 /CONTACT: Kathy S. Bartlett, 919-248-4302, or Sharon Haggerty, 919-248-8611, both of Burroughs Wellcome/ CO: Burroughs Wellcome Co. ST: North Carolina IN: MTC SU:


JT -- NY003 -- 7969 11/28/91 08:06 EST
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