menopause

Senshio - ospemifene

What is Senshio - ospemifene and what is it used for?

Senshio is a medicine indicated for the treatment of moderate to severe symptoms of vulvovaginal atrophy (dryness, irritation and pain around the genital area and painful sexual intercourse) in post-menopausal women. It is used in patients who cannot resort to locally applied estrogen therapy. Senshio contains the active substance ospemifene

How is Senshio - ospemifene used?

Senshio is available as tablets (60 mg). The recommended dose is one tablet once a day with food at the same time each day. Treatment should continue only as long as the benefit outweighs the risk. The medicine can only be obtained with a prescription.

How does Senshio - ospemifene work?

Levels of estrogen (sex hormone) decrease in women who have passed menopause. This lack of estrogen causes a thinning of the tissues inside and outside the vagina and a reduction in the amount of mucus that keeps the vaginal environment moist. The resulting dryness makes the sexual relationship painful and causes irritation and pain around the genital area. The active substance in Senshio, ospemifene, is a selective estrogen receptor modulator (SERM). That is, it stimulates the estrogen receptor present in some tissues of the body, including the vagina. By stimulating this receptor in vaginal tissue, ospemifene helps fight the symptoms of vulvovaginal atrophy. However, ospemifene does not stimulate estrogen receptors in other tissues such as breasts and uterus, where stimulation could cause hyperplasia (growth) of tissues that can develop into cancer.

What benefit has Senshio - ospemifene shown during the studies?

Senshio was compared to placebo (a dummy treatment) in two important studies involving over 1 700 post-menopausal women with vulvovaginal atrophy. The main measure of effectiveness was related to changes in symptoms, including pain associated with sexual activity and vaginal dryness, reported by a validated questionnaire. When needed, women also received a non-hormonal vaginal lubricant. In the first study, 66% of patients treated with Senshio reported a relief from vaginal dryness (mild or absent symptoms) after a 12-week treatment compared to 49% of placebo-treated women. In the second study, 62% of women treated with Senshio noticed relief from vaginal dryness after 12 weeks compared to 53% of patients treated with placebo. Regarding pain during sexual intercourse, 58% of women who used Senshio reported relief in the first study (compared to 42% in the placebo group), while 63% reported relief during the second study (compared to 48% in the placebo group). Studies have also shown that Senshio has helped restore the vaginal environment, including acidity and tissue thickness.

What is the risk associated with Senshio - ospemifene?

The most common side effects with Senshio (which may affect up to 1 in 10 people) are vulvovaginal candidiasis and other fungal (fungal) infections, hot flushes, muscle spasms, vaginal and genital secretions and a rash. Some women should not use Senshio. These include patients who have or have had blood clotting disorders in their veins, such as deep vein thrombosis, pulmonary embolism (formation of a blood clot in the lungs) and thrombosis of the retinal vein (formation of a blood clot in the vein located in the back of the eye). In addition, Senshio should not be used in women who have or could have breast cancer or another sex hormone dependent cancer, such as endometrial cancer (uterine cancer). Finally, it should not be used in patients with vaginal bleeding of unknown origin or in patients with endometrial hyperplasia (abnormal thickening of the lining of the uterus). For the full list of all side effects reported with Senshio and its limitations, see the package leaflet.

Why has Senshio - ospemifene been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Senshio's benefits are greater than its risks and recommended that it be approved for use in the EU. Compared to placebo Senshio showed relief from the symptoms caused by vulvovaginal atrophy in postmenopausal women. The CHMP considered that the degree of improvement observed with Senshio was comparable to that observed with other estrogen-based therapies applied in the vagina. Considering that Senshio is given by mouth, the CHMP is of the opinion that the medicine is a viable alternative for women who cannot be treated with local therapy. The CHMP considered that the safety profile of Senshio, which has been studied for a maximum period of 15 months, was in line with that of similarly acting drugs (selective estrogen receptor modulators or SERMs). However, the committee noted that long-term use of SERMs could be associated with risks such as endometrial hyperplasia, stroke and venous thromboembolism and called for further studies to be conducted to investigate these risks with Senshio.

What measures are being taken to ensure the safe and effective use of Senshio - ospemifene?

A risk management plan has been developed to ensure that Senshio is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Senshio, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Senshio will conduct an observational study to further investigate potential long-term risks such as endometrial hyperplasia, stroke and venous thromboembolism. Further information is available in the summary of the risk management plan.

More information on Senshio - ospemifene

On 15 January 2015, the European Commission issued a marketing authorization for Senshio, valid throughout the European Union. For more information on Senshio therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.