FDA, New Products, Regulatory

TherapeuticsMD wins FDA nod for hormone therapy, capping off drugmaker’s prolific year

The FDA has approved TherapeuticsMD’s $TXMD hormone therapy for hot flashes associated with menopause, marking the women’s health drugmaker’s third approval this year.

Bijuva, which was approved with a boxed warning of cardiovascular disorders, probable dementia as well as breast and endometrial cancer, is an oral treatment that contains molecularly identical (bio-identical) versions of the hormones estradiol and progesterone for menopausal women with a uterus experiencing moderate-to-severe vasomotor symptoms. The drug will be made available in the second quarter of next year, the company said on Monday.

There are roughly 43 million women in the United States of menopausal age (45-64 years). As their ovaries cease hormone production, levels of circulating estrogen fall, often causing vasomotor symptoms — hot flashes or flushes — in addition to sleep and mood disturbances. Hot flashes occur in up to to 80% of women, and can last for years.

Women have access to a range of options to deal with these symptoms: FDA-approved synthetic (non-bio-identical) hormones; separate FDA-approved bio-identical estrogen and progesterone products that are used together but are not sanctioned for combination use; or compounding pharmacies that combine the two bio-identical therapies if requested by patients, but whose products are not regulated by the FDA. Altogether, some 15 to 20 million annual prescriptions are written for this slate of products, the company said.

Robert Finizio

“The combination of these markets are a multi-billion dollar opportunity which we believe we can obtain significant share,” TherapeuticsMD chief and co-founder Robert Finizio told Endpoints News.

Bijuva is therefore poised to be a potential blockbuster product as the convenient, FDA-regulated option for a combination bio-medical hormone therapy, according to Cowen analysts as cited recently by Reuters — although TherapeuticsMD acknowledges there is no evidence that suggests bio-identical hormones are safer or more effective than synthetic hormones.

The company has not finalized a price for the drug, Finizio said, but expects the product will be priced at parity to existing treatments.

The drug was cleared for approval on the basis of a placebo-controlled late-stage study that showed Bijuva induced a statistically significant reduction in hot flashes, while diminishing the risks to the endometrium.

The approval marks a fecund year for the drugmaker, which in recent months has secured the approval of two other products — a contraceptive device and a treatment for vaginal pain associated with sexual activity — from the FDA.


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