Painful sex? New treatment for menopausal women on its way to pharmacies
For menopausal women who experience painful sex, a new treatment is on its way to pharmacies.
Boca Raton-based TherapeuticsMD began distributing its new product, Imvexxy, to stores recently. It will be available at all major retailers such as CVS, Walgreens and Walmart, as well as small pharmacies.
TherapeuticsMD, which is focusing on new health products for women, received FDA approval in May to market Imvexxy. The vaginal gelcap insert was developed for menopausal women who suffer from vaginal dryness.
"We expect to have strong demand for the product," said John Milligan, president of TherapeuticsMD. "A lot of women are going to find it very effective for this condition."
A doctor's prescription is necessary to purchase Imvexxy, which costs about $35 in an insurance co-pay or with coupons online, said TherapeuticsMD CEO and co-founder Robert Finizio.
The FDA's approval of Imvexxy was based on the results of a Phase 3, double-blind clinical trial that evaluated the safety and efficacy of 4- and 10-microgram dosages, compared with a placebo for 12 weeks.
Milligan said as required by the FDA, TherapeuticsMD will do follow-up studies on women prescribed Imvexxy, as there is always a risk of endometrial cancer in women with a uterus who use estrogen-only therapy. Imvexxy's package label warns users to report any unusual vaginal bleeding to their doctor.
But the clinical trial showed that women who tried Imvexxy had "very little or no side effects," Finizio said. Some women reported headaches, breast tenderness or nausea, according to the Imvexxy.com site.
The treatment proved effective in "less than two weeks" for women participating in the clinical trial, Finizio added.
TherapeuticsMD has built an internal team of 250 sales representatives to introduce the treatment to physicians nationwide. It plans TV and web advertising.
For marketing purposes, executives were pleased that the FDA approved the name "Imvexxy," Milligan said. "It sounds close to 'I'm sexy,' which is a memorable name."
Competing products include Allergan's Estrace Cream, Pfizer's Premarin Cream and Novo Nordisk's Vagifem. There's also an oral medication, Duchesnay USA's Osphena.
TherapeuticsMD said its product is different from others on the market because it can be used any time of the day and requires no applicator. It also contains a low dose of estradiol, a form of the hormone estrogen.
Dr. Jay Cohen, an obstetrician-gynecologist in Plantation, said a low-dose estrogen treatment for vaginal dryness fills "a huge unmet need in this country." The condition affects about 32 million menopausal women in the United States, according to TherapeuticsMD.
"Fifty percent are sexually active into their late 70s," Cohen said. "A woman lives 20 to 30 years in menopause, and this gets worse and worse for women."
TherapeuticsMD was founded in 2008 and went public in 2016. Revenues in 2017 were $16.8 million, primarily from sales of the company's multivitamins, VitaMedMD, developed for pregnant women.
While the company is still losing money, Finizio said TherapeuticsMD could turn profitable over the following year, if new treatments are approved and new sales are successful.
TherapeuticsMD also is developing a proposed treatment for hot flashes. The company hopes to receive an answer on marketing clearance from the FDA by the end of October.
That proposed treatment is in the form of one soft-gel capsule of estradiol, a form of estrogen, and progesterone. Today, many women have to take two different medications to treat hot flashes and other menopausal symptoms.
Also, in late July, TherapeuticsMD acquired the U.S. license to distribute a new contraceptive developed by Population Council, a New York-based, nonprofit research organization funded by the Bill & Melinda Gates Foundation. The agreement is contingent on the contraceptive being cleared by the FDA, which is anticipated in mid-August, Finizio said.
Milligan describes the contraceptive as a "long-acting vaginal system or ring that is patient-controlled." He said patients can take out the ring themselves, unlike an IUD that has to be inserted and removed by a doctor. "If you want to get pregnant, you take it out and stop using it," he said.
He thinks the product will be attractive to women who travel, those in the military, and college students.
The company last month announced a new partnership and license that could boost future sales.
TherapeuticsMD has partnered with Montreal-based Knight Therapeutics, a pharmaceutical company that is licensing Imvexxy and the proposed "hot flashes" treatment for distribution in Canada.
Knight made a $20 million investment in TherapeuticsMD, part of a recent $85 million round of financing. TherapeuticsMD has raised more than $500 million in private equity, according to Finizio.
TherapeuticsMD's stock price has ranged from $4.34 a share to $7.66 a share over 52 weeks in Nasdaq trading.
Some Wall Street analysts said the license and contraceptive would expand TherapeuticsMD's market to all the life stages of women, from child-bearing age to menopause.
TherapeuticsMD "sits in a unique position to consolidate assets in this space," wrote Annabel Samimy, managing director for specialty pharmaceuticals research at Stifel Financial Corp., in a report in early August.
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