The new drug ospemifene (trade names EU: Senshio, US: Osphena/Ophena) has been approved in Germany since January 2015 for menopausal women with moderate to severe symptoms due to vaginal atrophy who cannot have localized hormone therapy.
Around their mid-forties, women’s bodies gradually start making less of the female sex hormone estrogen. Their monthly periods become less regular and eventually stop completely. A woman has reached menopause when she has had her last period. The associated hormonal changes can cause symptoms such as hot flashes and sweats. The mucous membrane lining the vagina also changes: It becomes thinner and drier. The medical term for these changes is vaginal atrophy. It can cause symptoms like burning, itching, vaginal dryness and pain during sex.
Ospemifene is an option for post-menopausal women who experience moderate to severe symptoms. The drug aims to increase the production of estrogen in order to restore the vaginal lining and reduce symptoms.
Ospemifene is taken at the same time once a day in tablet form (60 mg) with a meal.
Hormone therapy is the standard treatment option for women with moderate to severe symptoms due to vaginal atrophy. The treatment involves a combination of estrogen and gestagen if the uterus is still intact. If the uterus has been removed (hysterectomy), only estrogen is used. Individualized supportive care is another treatment option. It aims to relieve the symptoms and improve quality of life.
In 2016 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether ospemifene has any advantages or disadvantages compared with the standard treatments for women with moderate and severe symptoms due to vaginal atrophy.
However, the manufacturer did not provide any suitable data with which to do the assessment.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of ospemifene (EU: Senshio, US: Osphena/Ophena).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ospemifene – Benefit assessment according to §35a Social Code Book V. Dossier assessment A16-21. Cologne: IQWiG. July 27, 2016.
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