First Continuous Combined Hormone Replacement Patch Approved for Marketing in Europe

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First continuous combined hormone replacement patch approved for marketing in Europe.

The Swedish medical products agency Läkemedelsverket recently approved "Levonor TDS," a transdermal patch developed by Labtec GmbH for hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women. The product is the first transdermal patch approved in Europe for the continuous combined HRT. The active principles in the patch are levonorgestrel and estradiol.

Hormone replacement therapy in postmenopausal women with estrogens can relieve postmenopausal vasomotor symptoms and prevent osteoporosis. But after oral application conjugated estrogens and especially estradiol are subject of an extensive first-pass metabolism. The transdermal application of estradiol circumvents the hepatic first-pass metabolism and prevents unphysiologically high estrone concentrations and undesired effects as the induction of liver proteins, such as renin substrate.

The treatment with estrogen alone, however, increases the risk of endometrial carcinoma due to the estrogen induced proliferation of the endometrium. Sequential addition of a progestogen prevents endometrial hyperstimulation. The disadvantage of this regimen is that many postmenopausal women dislike the regular bleeding induced by cyclic progestogen.

Levonor TDS represents an exceptional approach and the logical next and possibly ultimate level of development in transdermal HRT: a continuous combination patch incorporating all previous innovations and advantages while offering the menopausal user freedom from monthly bleedings. Thus it most closely approximates the natural menopausal situation while providing the benefits of HRT therapy and the convenience of once weekly dosing. With a daily delivered dose of 50µg estradiol and 40µg levonorgestrel, the product meets the demands of low dose hormone replacement therapy.

Approval was granted under the mutual recognition procedure (MRP) using Sweden as reference member state. The product is available for licensing worldwide.

Company Information:

Labtec GmbH is a leading drug delivery company specialised on development of matrix-type transdermal and topical patches as well as fast dissolving oral films (Rapidfilms).

Contact:

Dr. Ingo Lehrke; Business Development & Licensing

Labtec GmbH | Raiffeisenstrasse 3a | D-40764 Langenfeld | Germany | T: +49 2173 9735-0

Web: labtec-pharma.com

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INGO LEHRKE
Labtec GmbH
+49-2173-97350
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