FDA approves Vivelle's osteoporosis prevention indication
New low dose formulation also approved
On August 18, the U.S. Food and Drug Administration (FDA) approved Noven Pharmaceuticals' (Miami, FL) Vivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis. Vivelle, marketed by Novogyne Pharmaceuticals (a joint venture between Noven and Novartis), had been available for treating menopausal symptoms since March 1996.
Vivelle uses Noven's transdermal adhesive matrix technology to deliver estradiol, the primary estrogen produced by the ovaries, through a transdermal patch applied twice weekly.
Noven's transdermal delivery systems incorporate a thin, solid state, multi-laminate construction with a drug-bearing interpolymeric adhesive. On one side the patch has a release liner that, when removed, exposes a pressure-sensitive adhesive. This adhesive functions as both the drug platform and as the means of affixing the system to the patient's skin. The outside of the patch is comprised of a specialized backing material tailored to the drug being delivered and the length of time that the system is intended to be worn. The patch can administer different amounts of drug needed by the patient, and its shape is designed so that it can be worn comfortably with excellent adhesion.
Noven's transdermal systems can be modified to deliver a wide variety of chemical entities. The systems' blend of polymers modulate the solubility of the drug in the adhesive, allowing delivery of lipophilic and hydrophilic drugs while minimizing the amount of drug needed in the adhesive. By reducing the dependence of transdermal systems on chemical enhancers, irritation at the delivery site is significantly reduced, so that larger molecules, previously believed to be unsuitable for transdermal delivery, can be administered at effective doses without irritation.
Vivelle is available in four dosage strengths (0.0375, 0.05, 0.075 and 0.1 mg/day). A new low dose of Vivelle, 0.025 mg/day, was also approved by the FDA for postmenopausal osteoporosis and is expected to be available in U.S. pharmacies in late 2000.
Noven manufactures and markets what it calls "the world's smallest estrogen transdermal delivery system," as well as the only combination estrogen/progestin transdermal delivery system available in the United States, and a transmucosal patch.
Noven's transmucosal delivery systems adhere to the inner lining of the mouth and are suitable for different molecules than transdermal systems. Large bio-engineered molecules, like peptides, proteins and carbohydrates, usually must be injected because they can be inactivated by digestion and are simply too large to be delivered with a skin patch. The lining of the mouth, however, is thin and highly vascular, permitting larger molecules to pass into the bloodstream rapidly. Noven believes that its transmucosal patch will offer a viable alternative to injections, particularly for acute indications. The company believes its DentiPatch lidocaine system, already on the market, to be a viable alternative to anesthetic injections.
For more information, contact James B. Messiry of Noven Pharmaceuticals at 305-253-1916.
Edited by Angelo DePalma
Managing Editor, Pharmaceutical Online