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Supplemental New Drug Application submitted for new, 5 mg Androderm testosterone transdermal "unipatch".

PHILADELPHIA and SALT LAKE CITY--(BUSINESS WIRE)--Oct. 29, 1996-- SmithKline Beecham (NYSE:SBH) and TheraTech Inc. (NASDAQ:THRT) Tuesday announced that TheraTech has submitted a Supplemental New Drug Application (SNDA) to the U.S. Food and Drug Administration (FDA) for its new, 5 milligram per day (5 mg/day) Androderm(R) testosterone transdermal "unipatch" system.

Like the original 2.5 milligram per day (2.5 mg/day) Androderm patch, the "unipatch" is for the treatment of men suffering from hypogonadism, or testosterone deficiency. Because most patients currently on Androderm treatment apply two 2.5 mg/day patches nightly, the Androderm "unipatch" offers a simpler, more convenient treatment.

The FDA cleared the original 2.5 mg/day Androderm patch for marketing in September 1995. SmithKline Beecham launched the product in the United States last November, and it quickly became the most frequently prescribed transdermal testosterone product on the market.

Clinical trials in hypogonadal men demonstrated that the new 5 mg/day patch, while only slightly larger than the original 2.5 mg/day Androderm patch, produces testosterone blood levels that are equivalent to those achieved by the application of two 2.5 mg/day Androderm patches. Moreover, these blood levels approximate the normal circadian pattern of testosterone levels observed in healthy young men.

Androderm patches treat hypogonadism by delivering testosterone, a naturally occurring hormone that is essential for the development and maintenance of male physical and sexual characteristics. Men with testosterone deficiency can suffer from decreased libido, impotence, fatigue and depressed mood. Sub-normal testosterone levels may also contribute to muscle-wasting and osteoporosis in older men.

Prior to the introduction of Androderm, the most commonly prescribed treatments for hypogonadism included intra-muscular injections of testosterone ester administered every two to four weeks, and a patch that must be applied to the shaved scrotum.

Androderm patches, on the other hand, can be applied to the abdomen, back, upper arms or thighs. Unlike the intra-muscular injections, Androderm restores male hormonal balance to physiologic levels.

By mimicking the natural diurnal testosterone cycle, Androderm eliminates the peaks and troughs associated with intra-muscular injections. Moreover, in comparison to intra-muscular injections, Androderm was associated with lower levels of PSA (prostate specific antigen) and produced fewer elevations in hematocrit.

Androderm was generally well tolerated in clinical trials. While 53 percent of patients experienced application site reactions at some time during treatment, only 5 percent discontinued treatment due to chronic irritation and 4 percent due to allergic contact dermatitis.

Local skin reactions may be relieved by treatment with topical hydrocortisone or antihistamine products. Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Androderm must not be used in women or in patients with known hypersensitivity to any of its components.

SmithKline Beecham has marketing rights to Androderm in the United States, Canada and much of Europe, as well as Australia and New Zealand. To date, in addition to the United States, SmithKline Beecham has launched the 2.5 mg/day patch in the United Kingdom and has received clearance to market it in Switzerland.

SmithKline Beecham -- one of the world's leading health care companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products, and provides health care services including clinical laboratory testing, disease management and pharmaceutical benefit management. For company information, visit SmithKline Beecham on the worldwide Web at

TheraTech Inc., headquartered in Salt Lake City, is a leader in the development of innovative products based on controlled release drug delivery technologies. Working independently, as well as with corporate partners, the company has developed a wide range of drug delivery products, including transdermal patches, oral transmucosal products for the delivery of peptide drugs, oral controlled-release products and topical preparations.

Any statements released by TheraTech Inc., that are forward looking are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Editors and investors are cautioned that forward looking statements involve risk and uncertainties that may affect the company's business prospects and performance. This includes economic, competitive, governmental, technological and other factors discussed in the company's filings with the Securities and Exchange Commission on forms 10-K, 10-Q and 8-K.

CONTACT: TheraTech Inc., Salt Lake City

Alexander L. Searl or Alan Behunin, 801/588-6200


SmithKline Beecham, Philadelphia

Sharyn Arnold, 215/751-7074 (Media)

Richard Williams, 215/751-7002 (Investors)
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Publication:Business Wire
Date:Oct 29, 1996
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