Minivelle™ (Estradiol Transdermal System), The Smallest Estrogen Patch, Now Available In U.S. Pharmacies

Main Category: Menopause
Also Included In: Endocrinology;  Women's Health / Gynecology
Article Date: 31 Jan 2013 - 1:00 PST


Provides Effective Relief from Hot Flashes and Night Sweats Due to Menopause

Noven Pharmaceuticals, Inc., the manufacturer of Vivelle-Dot® (estradiol transdermal system), today announced the availability of Minivelle™ (estradiol transdermal system) by prescription in U.S. pharmacies. On October 29, 2012, the U.S. Food and Drug Administration (FDA) approved Minivelle™ for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as hot flashes and night sweats.

Minivelle™ is the smallest estrogen patch currently available. It is 34 percent smaller than Vivelle-Dot® and, at its lowest strength (0.0375 mg/day), has nearly the same surface area as a dime.

"Hot flashes and night sweats are the most commonly reported symptoms of menopause among women, said Mary Jane Minkin, M.D.,* clinical professor of obstetrics and gynecology at Yale University School of Medicine. "The availability of Minivelle™ in its unique size is significant as it offers women a discreet option to help manage these menopause symptoms."

Minivelle™ is round with smooth, curved edges that may help prevent lifting or snagging associated with everyday wear. It leaves almost no sticky residue and causes almost no skin irritation. During clinical pharmacology studies with Minivelle™, 35 percent or less of subjects experienced barely perceptible erythema. Minivelle™ stays in place during showering and exercising and 100 percent of the subjects reported that their patch stayed on completely over the wear period.

"The launch of Minivelle™ is an example of our commitment to providing innovative products tailored to women's active and busy lifestyles, and adds to our growing portfolio - established more than 16 years ago - of treatment options for menopausal women," said Jeffrey F. Eisenberg, Noven's President and Chief Executive Officer.

As a part of its commitment, Noven offers a savings program to help reduce Minivelle™ co-pays for eligible patients. On co-pays up to $70, patients pay no more than $15 for a one-month supply. On co-pays in excess of $70, patients may qualify for up to $55 in savings for a one-month supply. Patients can take advantage of this offer each month, for up to 12 uses. Restrictions apply. Physicians and patients should review the full terms and conditions here.

"I'm excited to talk to my doctor about Minivelle™, which is from the manufacturer of the patch I've known and trusted to help relieve my menopausal hot flashes and night sweats," said Karen Giblin,* founder of Red Hot Mamas, a menopause education and support program. "I never want to feel like menopause defines me, and the small size of Minivelle™ is appealing as it can help alleviate my symptoms, yet no one has to know I'm wearing it."

About Minivelle™

Minivelle™ is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as night sweats and hot flashes. At 2.48 cm2, the patch, at its lowest strength (0.0375 mg/day), has nearly the same surface area as a dime, making it the smallest estrogen therapy patch currently available. Minivelle™ has been approved with four dosing options - 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day. Minivelle™ is manufactured by Noven Pharmaceuticals, Inc. (the manufacturer of Vivelle-Dot®), and is marketed and sold through the Women's Health unit of Noven's subsidiary, Noven Therapeutics, LLC.

Minivelle™ contains bioidentical estradiol, a plant-based estrogen that is chemically identical to the estrogen produced naturally by a woman's body. This does not mean there are differences in safety or efficacy compared to other estrogen therapies. Minivelle™ is designed to release estradiol continuously upon application, increasing estradiol levels above baseline within four hours, and, with its DOT Matrix™ technology, allows for efficient delivery of estradiol.

Minivelle™ is bioequivalent to Vivelle® (estradiol transdermal system), with the same demonstrated safety and efficacy for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as hot flashes and night sweats. No clinical trials were conducted with Minivelle™. The most commonly reported adverse events for Vivelle® (≥5 percent) were headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses, and irregular vaginal bleeding or spotting.

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