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Prescription Pediculicide Now Available From Medicis.


PHOENIX--(BW HealthWire)--October 13, 1999--

OVIDE(R) (malathion) Lotion, 0.5%, a prescription product to help physicians safely and effectively fight Pediculus humanus capitis, or head lice, was recently introduced by MEDICIS, The Dermatology Company(R).

Approximately 10 to 12 million Americans, mostly school-aged children, are infested with head lice each year. A growing body of evidence indicates that head lice are becoming increasingly resistant to presently available over-the-counter products, including synergized natural pyrethrins pyrethrins

the active insecticidal ingredients of the flowers of the pyrethrum plant. Can cause systemic or cutaneous allergic reactions. Are esters of pyrethrolone and cinerolone with chrysanthemum mono- and dicarboxylic acids.
 and permethrin permethrin /per·meth·rin/ (per-meth´rin) a topical insecticide used in the treatment of infestations by Pediculus humanus capitis, Sarcoptes scabiei, or any of various ticks; also applied to objects such as furniture and bedding. . There has been no evidence to suggest that more concentrated formulas or more frequent applications of over-the-counter products increase kill rates for lice or nits. Lice that are not susceptible to permethrin seem to be strongly resistant, regardless of the dose.1

"OVIDE(R) Lotion contains malathion 0.5%, and is a highly effective pediculicide pediculicide /pe·dic·u·li·cide/ (pe-dik´u-li-sid)
1. destroying lice.

2. an agent that destroys lice.


pe·dic·u·li·cide
n.
An agent used to destroy lice.
 and ovicide ovicide /ovi·cide/ (o´vi-sid) an agent destructive to the eggs of certain organisms.

ovicide

an agent destructive to the ova of certain organisms, usually helminths and arthropods.
," said Ronald C. Hansen, M.D., Professor of Pediatrics and Dermatology at the University of Arizona (body, education) University of Arizona - The University was founded in 1885 as a Land Grant institution with a three-fold mission of teaching, research and public service. , Tucson. "Clinical and laboratory studies on malathion 0.5% show that it delivers consistent cure rates, has low incidence of adverse reactions, and has an efficient kill rate on both lice and their ova."2,3

Presently when over-the-counter treatments fail to eliminate head lice infestations, lindane lindane: see insecticides.  is commonly prescribed. "However, in my clinical experience, lindane does not appear to consistently kill adult lice or nits," said Dr. Hansen. In addition, because of possible neurotoxic effects resulting from overuse, the FDA in 1996 recommended labeling changes that encourage lindane's use only for patients who have either failed to respond to adequate doses, or are intolerant of, other approved therapies. Until now, physicians had few options for treating resistant head lice.

In controlled clinical studies with malathion 0.5%, 94.5% of subjects treated were lice-free 24 hours after treatment, and 90.4% of subjects were still lice-free after seven days.4 "When used as directed, OVIDE(R) Lotion provides patients with a safe and effective solution for the treatment of head lice," said Dr. Hansen.

The adverse side effects reported in clinical trials of malathion lotion 0.5% were temporary increase of dandruff in those prone to this condition and skin and scalp irritation. Accidental contact with the eyes may result in mild conjunctivitis conjunctivitis (kənjəngtəvī`təs), inflammation or infection of the mucosal membrane that covers the eyeball and lines the eyelid, usually acute, caused by a virus or, less often, by a bacillus, an allergic reaction, or an . OVIDE(R) Lotion is contraindicated for neonates and infants. Because the product contains alcohol, parents should be advised about the risk of flammability. This product should not be used in conjunction with or near a hair dryer, curling iron, curlers or any other electric or heated device.

If lice are detected, parents are advised to ask their physician about OVIDE(R) Lotion. OVIDE(R) Lotion is now available by prescription at major retail pharmacies in two-ounce bottles (NDC 99207-650-02) through MEDICIS, The Dermatology Company(R). For more information about OVIDE(R) Lotion, please call 1-800-550-5115.

MEDICIS, The Dermatology Company(R) is a subsidiary of Medicis Pharmaceutical Corporation (NYSE NYSE

See: New York Stock Exchange
:MRX). Medicis is the leading independent pharmaceutical company in the United States focusing primarily on the treatment of dermatological conditions. Medicis develops and markets leading products for major segments within dermatology including acne, fungal infections, psoriasis, eczema, rosacea, head lice and cosmesis (improvement in the texture and appearance of skin). Primary products include prescription brands DYNACIN(R), TRIAZ(R), LUSTRA Lustra® Hydroquinone Dermatology A topical agent used to manage UV-induced skin discoloration and hyperpigmentation due to trauma, pregnancy, OCs, HRT. See Tanning. (R), LOPROX(R), OVIDE(R), LIDEX(R), SYNALAR(R), TOPICORT(R), NOVACET(R) and A/T/S(R); the over-the-counter brand ESOTERICA(R); and BUPHENYL(TM), a prescription product indicated in the treatment of Urea Cycle Disorder urea cycle disorder Any disorder in which the body is unable to excrete waste nitrogen–ammonia–resulting in mental and behavioral dysfunction, coma, death .

Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties which may cause actual results to differ materially from the statements made, including the Company's dependence on sales of key products, uncertainty of future financial results and fluctuations in operating results, dependence on the Company's acquisition strategy, new product introductions and other risks described from time to time in the Company's SEC filings. These forward-looking statements represent the judgment of the Company, as of the date of this release, and Medicis disclaims any intent or obligation to update these forward-looking statements.

1. Pollack FJ, Kiszewski A, Armstrong P, Hahn C, Wolfe N, Radman HA,

Laserson K, Telford III S, Spielman A. Differential permethrin

susceptibility of head lice sampled in the United States and

Borneo. Arch Pediatr Adolesc Med 1999; 153:969-973. 2. Taplin D, Castillero PM, Spiegel J, Merdcer S, Rivera AA,

Schachner L. Malathion for treatment of pediculus humanus var

capitis infestation infestation /in·fes·ta·tion/ (-fes-ta´shun) parasitic attack or subsistence on the skin and/or its appendages, as by insects, mites, or ticks; sometimes used to denote parasitic invasion of the organs and tissues, as by helminths. . JAMA JAMA
abbr.
Journal of the American Medical Association
 1982;247:3103-3105. 3. Meinking TL, Taplin D, Kalter DC, Eberle MW. Comparative efficacy

of treatments for pediculosis pediculosis /pe·dic·u·lo·sis/ (pe-dik?u-lo´sis) infestation with lice of the family Pediculidae, especially Pediculus humanus.

pe·dic·u·lo·sis
n.
The state of being infested with lice.
 capitis infestations. Arch Dermatol

1986;122:267-271. 4. Package Insert

OVD44799
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Date:Oct 13, 1999
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