TherapeuticsMD, Inc. Release: New Data On Compounded Prescription Practices Show Differences Among Medical Specialties

SAN FRANCISCO--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, will present data from a new survey showing substantial numbers of physicians across various specialties are unaware they are prescribing non-FDA-approved hormone therapies for the treatment of menopause symptoms.

“Prevalence of Use and Cost of Compounded Menopausal Hormone Therapy (CMHT).”

Dr. Ginger Constantine, president of EndoRheum Consultants LLC and a TherapeuticsMD clinical consultant, will present the findings in an oral presentation titled “Prescribing of FDA-Approved and Compounded Menopausal Hormone Therapy (MHT) Differs by Specialty” at the American College of Obstetricians and Gynecologists (ACOG) 2015 Annual Clinical and Scientific Meeting, May 5 at 8:15 a.m. PDT, in room 102 of the Moscone Convention Center South Building.

“While both FDA-approved and compounded MHTs are prescribed across specialties, there are differences by specialty in the prescriptions and prescribing practices,” said Constantine, who coauthored the research. “Also of interest, we found that many of the physicians who prescribed compounded hormones didn’t realize they were prescribing non-FDA-approved treatments. For example, there is no FDA-approved testosterone or DHEA product for women, yet up to 70 percent of the prescribers of these compounds thought they were FDA-approved for their female patients.”

The online survey screened 9,001 U.S. physicians from three specialty groups: internal medicine/family practice, OB/GYN and anti-aging/wellness physicians, 440 of whom completed the survey after having met the eligibility criteria of writing FDA-approved and compounded MHT drugs for at least six patients per month.

In a related presentation at ACOG, Dr. David F. Archer, a professor at Eastern Virginia Medical School, Norfolk, Va., and a TherapeuticsMD clinical consultant, will share an e-poster titled “Prevalence of Use and Cost of Compounded Menopausal Hormone Therapy (CMHT).” Archer will share the results from surveys of independent community pharmacies and dedicated compounding pharmacies that estimate annual revenues from compounded MHTs in the United States total $1.1-2.3 billion. According to extrapolations from published reports and revenue data, 22 to 46 million prescriptions (30-day supply) for compounded MHT are filled annually, found Archer, whose presentation is scheduled for May 5, 10:30 a.m. PDT, in room 102 of the Moscone Convention Center South Building.

Both Constantine and Archer will discuss the widespread use of compounded hormone therapy for treating symptoms of menopause, noting the lack of well-controlled clinical trials and quality oversight of compounded products warrant further research as well as education of both physicians and patients.

“Compounded menopausal hormone therapy routinely prescribed to U.S. women represents potential risks due to the unknown purity, potency, safety and efficacy of the compounded product,” Archer said.

ACOG is the nation’s leading group of OG/GYN physicians providing health care for women.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its patented SYMBODA™ technology platform, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s clinical development pipeline includes two phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins under the vitaMedMD^® and BocaGreenMD^® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.