Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ZOVIRAX (ORAL) REDUCES LESION HEALING TIME IN RECURRENT GENITAL HERPES

Executive Summary

ZOVIRAX (ORAL) REDUCES LESION HEALING TIME IN RECURRENT GENITAL HERPES, according to results of a multi-center trial published in the April 27 issue of JAMA. The double-blind, placebo-controlled study, Richard Reichman, MD, University of Vermont, et al, said, found that Zovirax (acyclovir) "shortens the duration of virus shedding and the duration of lesions in patients with" recurrent genital herpes. The study reported in JAMA is the pivotal trial submitted by Burroughs Wellcome in support of its NDA for use of oral acyclovir in genital herpes. The company filed the NDA in mid-1982. The drug is currently marketed in topical and I.V. forms. The firm has sponsored several short term (four to six months) studies of acyclovir use in prevention of recurrent outbreaks which are expected to be published in the near feature. Several longer term suppression studies, including a multi-center study, expected to last over one year, are also underway. The study was divided into two parts: part A, the abstract explains, in which "patients entered the study within 48 hours of the onset of lesions, and part B, in which the same patients self-initiated therapy as soon as possible after the onset of a recurrent episode. In both parts, patients received either acyclovir (200 mg) or placebo, five times daily for five days." Two hundred fifty patients were initially enrolled in the study, with 212 patients available for analysis in part A and 165 patients available in part B. Lesions of patients in the active drug group of part A healed in an average of 6.3 days compared to 7.4 days with placebo, the study found. In part B the results were more notable with healing time in patients receiving acyclovir averaging 5.7 days v. 7.2 days with placebo. No statistically significant difference was found between the two groups in duration of either itching or pain, although a positive trend for acyclovir was noted. Also no significant differences were seen in time to next recurrence of lesion outbreak, "suggesting that this therapy does not affect the latent state," the report states. Commenting on the study's significance the authors note that "this report established orally administered acyclovir as the first, well-documented therapeutic modality to affect both the virological and clinical course of recurrent genital herpes." Further, the reviewers note, "the prevention of new lesion formation, observed in the present study when the drug was administered early, suggests that prophylactic administration of oral acyclovir may be even more effective." In an editorial accompanying the article, William Wittington and Willard Cates Jr., MD, Centers for Disease Control, noted the potential market for prophylactic use of oral acyclovir is conservatively estimated at 1 mil. They expressed some concern that widespread use could result in development of resistant herpes strains and that toxicity effects of long-term use are unknown. The editorial asserted that the "best candidates" for therapy or prophylaxis are those "with a history of frequent recurrences." The editorial declared: "We advocate an approach that would use cautious clinical judgment. Our concerns about potential viral resistance and toxicity are theoretical at this time. Realistically, neither concern may be valid, but . . . the agent has been evaluated only in several carefully characterized patients."

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

OM014079

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel