FDA approves Noven’s new dose for Minivelle to prevent postmenopausal osteoporosis

In October 2012, the FDA approved Minivelle for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause, also known as hot flashes.

Minivelle includes bioidentical estradiol, a plant-based estrogen that is chemically identical to the estrogen produced naturally by a woman’s body.

Upon application, Minivelle releases estradiol continuously, increasing estradiol levels above baseline within four hours, and, with the company’s transdermal drug delivery technology, allows for efficient delivery of estradiol through the skin, bypassing first pass metabolism.

Following this approval, women who are using Minivelle to treat their VMS symptoms, can also use it prevent osteoporosis.

The company said that new 0.025mg/day patch is 33% smaller than Minivelle 0.0375mg/day that is already only about the size of a dime.

Currently, Minivelle is approved with five dosing options 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day, and 0.1mg/day, with the newly approved, lower dose of 0.025mg/day indicated for the prevention of postmenopausal osteoporosis only.

Noven chief medical officer and product development executive vice president Joel Lippman said the company is deeply committed to offering therapies that address women’s menopausal health.

"We’re pleased that we now have an additional indication and the new dosage strength available for Minivelle to allow women and their doctors to individualize their treatment to best fit their needs," Lippman said.

The company intends to introduce Minivelle’s new lower dose of 0.025mg/day in pharmacies in January 2015.