Internationellt pressmeddelande:
Organon investigates non-hormonal menopausal therapy for women suffering from hot flushes and (night)sweats

(Oss, The Netherlands): The initiation of Phase 2/3 studies announced by Organon today mark the development of a innovative non-hormonal approach to the treatment of hot flushes and (night)sweats in menopausal women. Two Moonstone trials will investigate the efficacy of a new type of drug known as Serotonin 2 Blockers (S2B) for the treatment of hot flushes; Org50081 is the first non-hormonal therapy to be systematically investigated in a randomized trial for the relief of vasomotor symptoms associated with the menopause.

Studies of the antidepressant agents known as selective serotonin reuptake inhibitors (SSRIs) and other similar compounds have already confirmed the role of the serotonergic system in the cause and relief of hot flushes [1,2,3].

The two Moonstone studies will recruit a total of 1800 women (900 per trial) and will take place in clinical centers throughout Australia, Europe and North, Central and Latin America. Menopausal women experiencing hot flushes may be eligible to take part in the studies, which have each received worldwide ethical approval.

“Currently, a frequently used treatment for hot flushes is hormone therapy in the form of estrogens alone or estrogen in combination with progestogens," says John van den Berg, Vice President and Global Venture Team leader responsible for the development of Org50081. However, estrogen based hormonal therapy is not an acceptable treatment for all women, and it hardly has effects on complaints such as insomnia or irritability. So there is a need for an alternative to hormone therapies, to increase the range of effective treatments and provide a remedy for women who cannot use estrogen. We hope the Moonstone studies will extend the management options for hot flushes and (night)sweats in menopausal women.”

Around 70% of women experience hot flushes during or after the menopause.
Indeed, hot flushes are the most characteristic menopausal symptom. They are evident as sudden sensations of heat around the head, neck, upper chest and back. Hot flushes, which may be accompanied by sweating (especially at night), flushing, palpitations and bouts of anxiety, are usually defined as vasomotor symptoms.

Subject to results of the Moonstone trials, Org50081 is hoped to become the first non-hormonal menopausal therapy for the relief of hot flushes, and extend Organon's range of treatments for women at and beyond the menopause. The trials of Org50081 will focus on women with vasomotor symptoms, insomnia and irritability.

“Organon has a long history in both menopause and mental health related R&D. The Org50081 compound is an intriguing combination of both” said John van den Berg.

Organon - headquartered in Roseland, NJ, USA - creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.

För ytterligare information

Mats Jonsson

References:

  1. Loprinzi CL, Sloan JA, Perez EA, et al. Phase III evaluation of fluoxetine for treatment of hot flushes. J Clin Oncol 2002; 20: 1578-1583.
  2. Stearns V, Beebe KL, Iyengar M, Dube E. Paroxetine controlled release in the treatment of menopausal hot flushes. JAMA 2003; 289: 2827-2834.
  3. Stearns V, Ullmer L, Lo’pez JF, Smith Y, Isaacs C, Hayes DF. Hot flushes.
    Lancet 2002; 360: 1851-1861.

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