Posted from: Friday, July 06, 2018 - 03:51 PM - Present

Imvexxy Approved to Treat Dyspareunia

May 25, 2018 – The U.S. FDA has approved Imvexxy™ (estradiol vaginal inserts), manufactured by TherapeuticsMD, to treat moderate-to-severe dyspareunia (vaginal pain associated with sexual activity) due to menopause. Dyspareunia is a symptom of vulvar and vaginal atrophy (VVA).

Available in both a 4mcg and 10mcg dose, Imvexxy currently offers the lowest FDA-approved dose of vaginal estrogen available in the U.S. market. It is also the only such product designed to be applicator-free. According to a press release from the manufacturer, the product dissolves completely once applied, and can be used at any time of the day.

In clinical trials, Imvexxy produced pain relief as soon as the second week, and the mean concentration of estradiol and estrone in patients’ bodies remained within the average postmenopausal range.

Imvexxy, like other estrogen products, carries black box warnings that it may increase the risk of blood clots, strokes, dementia, breast cancer, or endometrial cancer when used either alone or with progestin therapy.

TherapeuticsMD plans to launch Imvexxy in July 2018.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Sunday, September 23, 2018 - 02:05 AM.