Penederm Announces FDA Approval of Shorter Treatment Claim for Mentax; One Week Treatment for Athlete's Foot.FOSTER CITY, Calif.--(BW HealthWire)--Dec. 3, 1997--Penederm Incorporated (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DERM n. 1. The integument of animal; the skin. 2. (Anat.) See Dermis. ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for a new one-week dosing regimen for Mentax(R), its new topical antifungal product for the treatment of interdigital interdigital between two digits. interdigital cysts see interdigital pyoderma, pododermatitis. interdigital dermatitis 1. the early lesion in the development of infectious footrot in sheep; called also sheep scald. tinea pedis tinea ped·is n. See athlete's foot. Tinea pedis Fungal infection of the feet of the skin characterized by dry, scaly lesions. (athlete's foot). The new label reflects revised dosage instructions for the treatment of tinea pedis that allows topical application either twice-a-day for seven days, or once-a-day for four weeks. Mentax is the only topical antifungal product approved in the U.S. which has such a one-week dosing regimen. Mentax is Penederm's topical prescription antifungal product containing butenafine HCl 1% cream. Mentax was launched in the United States in the first quarter of 1997 for the treatment of three of the most common skin fungal infections: tinea pedis (athlete's foot), tinea corporis (ringworm ringworm or tinea (tĭn`ēə), superficial eruption of the skin caused by a fungus, chiefly Microsporum, Trichophyton, or Epidermophyton. ) and tinea cruris (groin fungus). Penederm has conducted several well-controlled studies in which Mentax was applied topically two times a day for one week or once-a-day for four weeks. Mycological mycological pertaining to or arising from mycology. cure rates were 79% five weeks post-treatment in the one-week studies and 90% four weeks post treatment in the four-week studies. One of the one-week studies, entitled "One-Week Therapy With Twice-Daily Butenafine 1% Cream Vehicle Versus Vehicle in the Treatment of Tinea Pedis: A Multi-Center, Double-Blind Trial" was published in the February 1997 issue of the Journal of the American Academy of Dermatology The American Academy of Dermatology (AAD) is the largest organization of dermatologists in the world. The Academy grants Fellowships and Associate Memberships, as well as Fellowships for Nonresidents (of the United States of America or Canada). . According to Donald L. Greer, Ph.D., Professor of Dermatology at Louisiana State University Louisiana State University and Agricultural and Mechanical College, generally known as Louisiana State University or LSU, is a public, coeducational university located in Baton Rouge, Louisiana and the main campus of the Louisiana State University System. Medical Center, "This FDA approval of one-week dosing confirms the fast-acting properties of butenafine, the active ingredient in Mentax. A study published in the Journal of the American Academy of Dermatology, which was one of the bases for this approval, demonstrated that the potency of butenafine allowed for a short time interval, not previously demonstrated with the older antifungal agents." Dr. Greer added, however, "Longer dosing periods may be necessary for more severe or chronic tinea pedis, and doctors should consider longer treatment when appropriate." Butenafine is the first of a new class of antifungal agents known as the benzylamines, which are chemically and pharmacologically related to the allylamine antifungal drugs. Japan-based Kaken Pharmaceutical Co., Ltd., developed Mentax formulations and markets the drug in Japan, where it has become one of the leading topical antifungals. Penederm acquired exclusive rights to the active compound in Mentax in North, Central and South America for topical use against skin and nail fungus. Penederm is a pharmaceutical company that specializes in development and marketing of prescription dermatology products. Any statements contained in this release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including, but not limited to, risks of product nonapproval or delays or post-approval reviews by the FDA or foreign regulatory authorities, the results of current and future licensing and other collaborative relationships, product development and market acceptance risks, product manufacturing risks, risks associated with the establishment and management of a contract sales force, the impact of competitive products and pricing, the results of financing efforts, developments regarding intellectual property rights and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , and other risks identified in the Company's Securities and Exchange Commission filings. Actual results, events or performance may differ materially. Readers are cautioned not to place undo reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. CONTACT: Penederm Incorporated Michael A. Bates Bates , Katherine Lee 1859-1929. American educator and writer best known for her poem "America the Beautiful," written in 1893 and revised in 1904 and 1911. , 650/358-0100 Recent news: www.businesswire.com/cnn/derm.htm or Feinstein Kean Partners Inc. Doug MacDougall, 617/577-8110 (Media Contact) |
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