30.05.2018 12:45:31

FDA Greenlights TXMD's Imvexxy; Stock Up In Early Trade

(RTTNews) - The FDA has finally approved TherapeuticsMD Inc.'s (TXMD) TX-004HR, branded as IMVEXXY, an applicator-free vaginal estradiol softgel.

IMVEXXY is indicated for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy in postmenopausal women.

IMVEXXY is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol available, noted the Company.

The FDA had turned down IMVEXXY last May, citing lack of long-term endometrial safety data.

Now that IMVEXXY has been approved, Robert Finizio, Chief Executive Officer of TherapeuticsMD, said, "We are excited to bring IMVEXXY to market as TherapeuticsMD's first FDA-approved drug as we strive to be the premier Women's Health Company."

The Company plans to offer IMVEXXY at a price in parity with other products that have been on the market for 10 to 30 years.

Pfizer's (PFE) Premarin, Endoceutics Inc.'s Prasterone and Shionogi Inc.'s Osphena are some of the FDA-approved products to treat women with moderate to severe dyspareunia (painful intercourse) that is due to menopause.

TXMD closed Tuesday's trading at $6.43, up 0.47%. In pre-market trading on Wednesday, the stock is up 19.60% to $7.69.

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