TherapeuticsMD Inc (NASDAQ:TXMD) Receives Approval For Its BIJUVA™ Capsules


TherapeuticsMD Inc (NASDAQ:TXMD) recently received approval for its BIJUVA™ Capsules of 1mg/100 mg from the United States Food and Drug Administration (FDA). BIJUVA™ is first and the only bio-identical combination of hormone therapy of progesterone and estradiol approved by FDA. It is the only single oral capsule treatment addressing moderate to severe symptoms of vasomotor in women during the menopause phase.

FDA approval opens up new opportunity for menopausal women

Vasomotor symptoms cause hot flushes and flashes in women with a uterus. TXMD is a healthcare company dedicated to developing innovative treatments for women. According to the director and Co-Founder of TXMD, Dr. Brian Bernick,”The approval of BIJUVA represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms. Menopausal women and their health care providers have been seeking bio-identical combination therapies for many years without an FDA-approved option.”

He further added that BIJUVA is the only bio-identical hormones’ combination to receive approval from FDA. It offers a proven bio-identical estradiol balance to reduce moderate to severe hot flushes/flashes. The combination includes bio-identical progesterone for reducing endometrium risks. According to the CEO and Co-founder at TXMD, Robert Finizio the approval from FDA is a landmark achievement for the company as it continues to develop a full portfolio of products for women for all their life’s stages.

Finizio stated further that BIJUVA treats an important requirement for bio-identical hormone therapy and offers women, their healthcare givers, and pharmacists a proven product with bio-identical combination and insurance coverage assurance. FDA approved the TXMD product based on the company’s clinical development program BIJUVA that includes Phase III Replenish Trial.

The trial evaluates the efficacy and safety of BIJUVA in postmenopausal uterus-bearing women who are generally healthy but suffer from moderate to severe hot flashes.

Around 80% US women in menopausal age suffer from hot flashes

According to the U.S. Census Bureau, around 43 million women in the United States belong to menopausal age between 45 and 64. The statistics say that around 80% of all these menopausal women suffer from night sweats and hot flashes symptoms. Analysts consider BIJUVA as the potential blockbuster as it addresses these issues of women successfully.

This report is for information purposes only, and is neither a solicitation or recommendation to buy nor an offer to sell securities. Financials Trend is not-a-registered-investment-advisor. Financials Trend is not a broker-dealer. Information, opinions and analysis contained herein are based on sources believed to be reliable, but no representation, expressed or implied, is made as to its accuracy, completeness or correctness. The opinions contained herein reflect our current judgment and are subject to change without notice. Financials Trend accepts no liability for any losses arising from an investor's reliance on the use of this material. Financials Trend sometimes gets compensated up to one hundred and fifty thousand dollars per month for featuring particular stocks. See site disclaimer for complete compensation. Financials Trend and its affiliates or officers currently hold no shares of these stocks. Financials Trend and its affiliates or officers will purchase and sell shares of common stock of these stocks, in the open market at any time without notice. Financials Trend will not update its purchases and sales of these stocks in any future postings on Financials Trend's websites. Certain information included herein is forward-looking within the context of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning manufacturing, marketing, growth, and expansion. The words "may", "would," "will," "expect," "estimate," "anticipate," "believe," "intend," " project," and similar expressions and variations thereof are intended to identify for ward-looking statements. Such forward- looking information involves important risks and uncertainties that could affect actual results and cause them to differ materially from expectations expressed herein. *Financials Trend does not set price targets on securities. Never invest into a stock discussed on this web site or in this email alert unless you can afford to lose your entire investment.