Otsuka Pharmaceutical Co., Ltd.

Nutraceuticals
April 12, 2019

EQUELLE: Dietary Supplement to Support Women's Health
Expansion of US business through launch of sales via D-to-C channel

  • EQUELLE contains equol, produced when soy is fermented by lactic acid bacteria. The product will be marketed in the U.S. via a direct-to-consumer (D-to-C) channel in order to contribute to the health of American women.
  • The website equelle.com provides menopause and equol-related information and products directly to women in the U.S. who prefer a natural, non-pharmaceutical approach to coping with menopausal symptoms.
  • This approach offers interactive communication with women who want to understand and manage their own health.

Otsuka Pharmaceutical Co., Ltd. subsidiary Pharmavite LLC began marketing EQUELLE directly to consumers (D to C) in the U.S. on April 11. EQUELLE is an equol-containing nutritional supplement that contributes to the health of women during menopause.

EQUELLE to be marketed
via D to C channel in the US

Pharmavite has launched the mail-order and information website equelle.com for easy purchase of the product, which has won the support of a large number of women for its reduction of symptoms associated with menopause. This D-to-C channel is more than just a sales route; the site provides information about equol and the physical changes that accompany aging, and supports interaction via email (telephone inquiries also accepted) about how to live life comfortably during menopause. The site also supports women's understanding of their personal health, with the aim to further contribute to the maintenance and promotion of women's health.

Equol is a metabolite of soy isoflavone daidzen, which is produced through the action of intestinal bacteria. Consumption of soybeans or soy isoflavones is expected to contribute to maintenance and improvement of women's health. Through many years of research into soybeans and clinical research in Japan and the U.S., Otsuka Pharmaceutical has identified equol as the active ingredient in soy and clarified its health benefits.

The American diet offers few opportunities to consume soybeans,*1 and only around 20 to 30 percent of American women are able to produce equol in their digestive tracts.*2 More than two million women in the U.S. enter menopause each year*3, around 85 percent of whom experience troublesome symptoms.*4 While hormone replacement therapy or other pharmaceutical treatments are common approaches to treating menopausal symptoms, a growing number of women would prefer to use a natural approach that does not rely on pharmaceuticals.*5 As a result, in 2017 EQUELLE was introduced as a new option in the U.S. through channels targeting healthcare professionals as a dietary supplement to reduce the frequency of hot flashes and relieve shoulder muscle stiffness associated with menopause.

  1. 1Data source: 2007 Soybean Production and Consumption, UN Food and Agriculture Organization (FAO)2007
  2. 2Data source: Journal of Japan Society for Menopause and Women's Health, 20: 313-332, 2012
  3. 3The North American Menopause Society. Overview of Menopause. Available at: http://www.menopause.org/docs/2012/cg_a.pdf/sfvrsn=2. Accessed April 16, 2015.
  4. 4Woods NF and Mitchell ES. Symptoms during the perimenopause: prevalence, severity, trajectory, and significance in women's lives. Am J Med. 2005; 118 Suppl B:14-24.
  5. 5Data source: The 2015 Gallup Study of Menopause Management Multi-sponsor Surveys, Inc.; n= 1018 (women aged 40-64)

EQUELLE (as marketed in the US)

Product name

EQUELLE

Contents / Daily dosage 120tablets; Daily dosage: 4 tablets/day (S-equol 10mg)
Structure/Function Claim*

Help reduce the frequency of hot flashes associated with menopause.

Relieve muscle discomfort associated with menopause.

*About Structure/ Function Claim:

In the US, dietary supplements are permitted to display structure/function claims. These claims are not pre-approved or evaluated by the FDA, but the manufacturer is required to substantiate the claim qith scientific evidence and submit a notification to the FDA.

EQUELLE has bes subjected to nutritional intervention studies with human volunteers conducted by a third-party specialized agency to confirm the structure/function claims indicated above.

Price 39.95 USD (1.3 USD/day)
Market launch April 11, 2019
Sales channel

About Pharmavite LLC

Pharmavite was established in California in 1971 as a vitamin and supplement manufacturer and marketer and became an Otsuka Pharmaceutical subsidiary in 1989. For more than 40 years the company has developed and produced health foods and supplements centering on its main Nature Made brand.