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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/723438/2014

EMEA/H/C/002780

EPAR summary for the public

Senshio

ospemifene

This is a summary of the European public assessment report (EPAR) for Senshio. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Senshio.

For practical information about using Senshio, patients should read the package leaflet or contact their doctor or pharmacist.

What is Senshio and what is it used for?

Senshio is a medicine used to treat moderate to severe symptoms of vulvovaginal atrophy (dryness, irritation and soreness around the genital area, and painful sexual intercourse) in women who have been through the menopause. It is used in women who cannot use oestrogen therapy that is applied locally.

Senshio contains the active substance ospemifene.

How is Senshio used?

Senshio is available as tablets (60 mg) The recommended dose is one tablet once a day taken with food at the same time each day. Treatment should be continued for as long as benefits outweigh risks.

The medicine can only be obtained with a prescription.

How does Senshio work?

In women who have been through the menopause, levels of the sex hormone oestrogen fall. This lack of oestrogen leads to a thinning of the tissues in and around the vagina and a reduction in the amount of mucus that keeps the vaginal environment moist. This can cause dryness leading to painful sexual intercourse, and irritation and soreness around the genital area.

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The active substance in Senshio, ospemifene, is a selective oestrogen receptor modulator (SERM). This means that it stimulates the receptor for oestrogen in some tissues in the body such as the vagina. By stimulating the oestrogen receptor in vaginal tissue, ospemifene helps to reverse symptoms of vulvovaginal atrophy. However, ospemifene does not stimulate oestrogen receptors in other tissues such as the breast and womb, where stimulation could cause hyperplasia (growth) of tissues which could lead to cancer.

What benefits of Senshio have been shown in studies?

Senshio has been compared with placebo (a dummy treatment) in two main studies involving over 1,700 postmenopausal women with vulvovaginal atrophy. The main measure of effectiveness was related to the change in symptoms such as pain associated with sexual activity as well as vaginal dryness using a validated questionnaire. Women also received non-hormonal vaginal lubricant for use as needed. In the first study, 66% of women using Senshio reported relief from vaginal dryness (mild or no symptoms) after 12 weeks' treatment compared with 49% in the placebo group. In the second study, 62% of women using Senshio reported relief from vaginal dryness after 12 weeks (compared with 53% in the placebo group). Regarding pain during sexual activity, 58% of women using Senshio reported relief in the first study (compared with 42% using placebo) and 63% reported relief during the second study (compared with 48% using placebo). The studies also showed that Senshio was effective in restoring the vaginal environment including its acidity and thickness of tissues.

What are the risks associated with Senshio?

The most commonly reported side effects with Senshio (affecting up to 1 in 10 people) are vulvovaginal candidiasis and other mycotic (fungal) infections, hot flushes, muscle spasms, vaginal and genital discharge, and rash.

Some women must not use Senshio, including those who have or have had problems with blood clots in veins such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye). Senshio must also not be used in women who have or who are suspected of having breast cancer or another cancer that is sex-hormone dependent such as endometrial cancer (cancer of the womb). In addition, it must not be used in patients with unexplained vaginal bleeding or patients with endometrial hyperplasia (abnormal thickening of the lining of the womb).

For the full list of all side effects and restrictions with Senshio, see the package leaflet.

Why is Senshio 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. Senshio was shown to improve symptoms of vulvovaginal atrophy in postmenopausal women when compared with placebo. The CHMP noted that the degree of improvement seen with Senshio was comparable to that seen with oestrogen treatments that are applied to the vagina. Considering that Senshio is given by mouth the CHMP considered that this medicine is a valuable alternative for women for whom local treatment is unsuitable.

The CHMP considered that the safety profile of Senshio, which was studied for up to 15 months, was in line with medicines working in a similar way (SERMs). The Committee noted however that long-term use of SERMs might be associated with risks such as endometrial hyperplasia, stroke and venous thromboembolism and requested that further studies be carried out to investigate these risks with Senshio.

Senshio

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

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 carry out an observational study to further investigate long-term potential risks such as endometrial hyperplasia, stroke and venous thromboembolism.

Further information can be found in the summary of the risk management plan.

Other information about Senshio

The European Commission granted a marketing authorisation valid throughout the European Union for Senshio on 15 January 2015

The full EPAR and risk management plan summary for Senshio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Senshio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2015.

Senshio

EMA/723438/2014