Item 8.01. Other Events. On July 30, 2014, TherapeuticsMD, Inc., a
Nevada corporation, filed a prospectus supplement with the
Securities and Exchange Commission under its effective shelf registration statements on Form S-3 (the "Prospectus") pursuant to Rule 424 promulgated under the Securities Act of 1933, as amended (the "Securities Act"). The discussion below contains certain updated disclosures regarding the Company's business included the Prospectus. Unless the context otherwise requires, all references in this Current Report on Form 8-K to "TherapeuticsMD," "TXMD," "Company," "our company," "we," "us," or "our" refer to TherapeuticsMD, Inc., a
Nevada corporation, and its subsidiaries, VitaMedMD, LLC, a
Delaware limited liability company, or VitaMed, and BocagreenMD, Inc., a Nevada corporation, or BocaGreenMD. vitaMedMD�, TherapeuticsMD�, and BocaGreenMD� are registered trademarks of our company.
Our Company
We are a women's health care product company focused on creating and commercializing products targeted exclusively for women. Currently, we are focused on conducting the clinical trials necessary for regulatory approval and commercialization of advanced hormone therapy pharmaceutical products. The current drug candidates used in our clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis and vaginal dryness. We are developing these hormone therapy drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of demonstrating equivalent clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products. Our drug candidates are created from a platform of hormone technology that enables the administration of hormones with high bioavailability alone or in combination. In addition, we manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter, or OTC, vitamins and cosmetics. We have obtained
U.S. Food and Drug Administration, or
FDA, acceptance of our Investigational New Drug, or IND, applications to conduct clinical trials for four of our hormone therapy drug candidates: TX-001HR, our oral combination of progesterone and estradiol; TX-002HR, our oral progesterone alone; TX-003HR, our oral estradiol alone; and TX-004HR, our vaginal suppository estradiol alone. We are currently conducting phase 3 clinical trials for TX-001HR and TX-002HR; and we currently intend to begin a phase 3 clinical trial for TX-004HR in the third quarter of 2014. We have no current plans to conduct clinical trials for TX-003HR.
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