Dyspareunia due to menopause
is a chronic, progressive medical
condition.1-3

In contrast to postmenopausal vasomotor symptoms – hot flushes, cold or night sweats – that usually improve over time, symptoms of VVA, including moderate to severe dyspareunia, persist throughout postmenopause.2,3

Note: Image is for illustrative purposes only. The occurrence and intensity of menopausal symptoms vary widely between women and depend on genetic, environmental, racial, lifestyle, and anthropometric factors. Black race, smoking, and overweight–in particular, central obesity–increase the prevalence and severity of vasomotor symptoms.3


Years
of her life could be spent in postmenopause.

Women enter menopause at an average age of about 52 years
and they have a life expectancy of approximately 82 years.4,5

In postmenopausal women, declining estrogen levels significantly alter vaginal physiology and can lead to moderate to severe dyspareunia,
a symptom of vulvar and vaginal atrophy (VVA).4,6,7


Percent
of postmenopausal women aged 57 to 64 years are sexually active.8

Some women may be sexually active for decades after menopause.8

Because some women are living longer and often continue to be sexually active after menopause, an effective treatment for moderate to severe dyspareunia could benefit a great number of postmenopausal women.9

References: 1. Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (Real Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013;10(7):1790-1799. 2. North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013;20(9):888-902. 3. Davis SR, Lambrinoudaki I, Lumsden M, et al. Menopause. Nat Rev Dis Primer. 2015;15004. doi:10.1038/nrdp.2015.4. 4. Shifren JL, Gass ML. NMS Recommendations for Clinical Care of Midlife Women Working Group. Menopause. 2014;21(10):1038-1062. 5. U.S. National Center for Health Statistics Reports. Census Bureau. Table 105. Life expectancy by sex, age, and race: 2008. Statistical Abstract of the United States: 2012. US Census Bureau Web site. http://www.census.gov/compendia/statab/2012/tables/12s0104.pdf. Accessed March 26, 2015. 6. Archer DF, Carr BR, Pinkerton JV, et al. Effects of ospemifene on the female reproductive and urinary tracts: translation from preclinical models into clinical evidence. Menopause. 2015;22(7):1-11. 7. Simon JA. Vulvovaginal atrophy: What is it, what causes it? OBG Management. 2015;(suppl):1-2. 8. Lindau ST, Schumm LP, Laumann EO, et al. A study of sexuality and health among older adults in the United States. N Engl J Med. 2007;357:762-774. 9. Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013;20(6):623-630.

The oral serm* for the chronic problem of
moderate to severe dyspareunia due to menopause

Osphena pill (not actual size)
OSPHENA® 60 mg

Once-daily oral1

  • No vaginal administration
  • Taken with food for absorption
  • Precise and consistent 60-mg dosing

Relieves pain1

  • Significantly improved moderate to severe dyspareunia associated with vulvar and vaginal atrophy (VVA) due to menopause

Well-studied1

  • 9 phase 2/3 trials
  • ~1900 postmenopausal women studied
  • Up to 52 weeks in duration (n=409)

Non-hormonal2,3

  • Works like an estrogen without the hormones
  • Specific tissue effects, with agonist effects in the vaginal tissue

Level a treatment designation from ACOG and NAMS4,5

prescription pad

Choose OSPHENA

For your appropriate patients with moderate to severedyspareunia due to menopause.

1

RELIEVE

OSPHENA provided
significant relief of
moderate to severe
dyspareunia
due to
menopause observed at
Week 12 (P<0.0001)1

2

REBUILD

OSPHENA is proven to
significantly rebuild
vaginal epithelium

as observed at Week 126

3

SUSTAINED

OSPHENA sustained§
physiological changes
in vaginal epithelium‡6

bottom cells

*SERM=selective estrogen receptor modulator. OSPHENA® should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.
Do not use estrogens or estrogen agonists/antagonists, fluconazole, or rifampin concomitantly with Osphena. Superficial and parabasal cells, pH.§OSPHENA® was
studied in a 52-week randomized, double-blind, placebo-controlled, long-term safety study conducted with 2 treatment groups: 60 mg (n=363) and placebo (n=63).

References: 1. Osphena [package insert]. Florham Park, NJ: Shionogi Inc; 2015. 2. Archer DF, Carr BR, Pinkerton JV, et al. Effects of ospemifene on the female reproductive and urinary tracts: translation from preclinical models into clinical evidence. Menopause. 2015;22(7):1-11. 3. Kangas L, Unkila M. Tissue selectivity of ospemifene: pharmacologic pro¬ le and clinical implications. Steroids. 2013;78:1273-1280. 4. ACOG Practice Bullet Number 141: Management of menopausal symptoms. Practice Bulletin No. 141. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2014:123(1):202-216. 5. North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of the North American Menopause Society. Menopause. 2013;20(9):888-902. 6. Data on file. Shionogi Inc.

Relieves the pain of moderate to severe Dyspareunia

Nearly 3 out of 4 women

experienced an improvement in moderate to severe dyspareunia at the Week 12
clinical assessment with OSPHENA®
72% (n=110) vs placebo 54% (n=113) (P=0.0012)1

Dyspareunia severity score 12-week mean change from baseline vs placebo2

Significant improvement
in Dyspareunia severity score

Study 1

%

P=0.0012

vs 33% placebo
Baseline: 2.7
OSPHENA: -1.39 (n=110)
Placebo: -0.89 (n=113)

Study 2

%

P<0.0001

vs 44% placebo
Baseline: 2.7
OSPHENA: -1.55 (n=301)
Placebo: -1.19 (n=297)

Study Design: Two 12-week, randomized, double-blind, placebo-controlled, parallel-group efficacy studies in 1745 generally healthy postmenopausal women. Coprimary efficacy endpoints for both clinical studies included: a mean change from baseline to Week 12 for percentage of superficial cells on a vaginal smear, percentage of parabasal cells on a vaginal smear, vaginal pH, and most bothersome symptom of VVA (moderate to severe dyspareunia) self-reported by the patient.

Rebuilds vaginal epithelium

Statistically superior improvements at Week 12 clinical assessment vs placebo1

  • Results were seen at Week 4 (secondary endpoint)
  • Results are from women in the mITT population.

Study Design: Two 12-week, randomized, double-blind, placebo-controlled, parallel-group efficacy studies in 1745 generally healthy postmenopausal women.
The first clinical study included 3 treatment groups: OSPHENA® (ospemifene) 30 mg (n=282), OSPHENA® 60 mg (n=276) and placebo (n=268).

The second clinical study included 2 treatment groups: OSPHENA® 60 mg (n=463) and placebo (n=456).


OSPHENA REDUCES VAGINAL pH
AT WEEK 122

Study Design: Two 12-week, randomized, double-blind, placebo-controlled, parallel-group efficacy studies in 1745 generally healthy postmenopausal women.
The first clinical study included 3 treatment groups: OSPHENA® (ospemifene) 30 mg (n=282), OSPHENA® 60 mg (n=276) and placebo (n=268).

The second clinical study included 2 treatment groups: OSPHENA® 60 mg (n=463) and placebo (n=456).

Sustained physiological changes in vaginal epithelium at week 52

Daily use of OSPHENA sustained* improvements at Week 521

(percentage of cells at Week 52)1

Click here to see physiological change

Placebo percentage of superficial cells was 0.7 at baseline and 0.8 at Week 52
Placebo percentage of parabasal cells was 47.8 at baseline and 63.9 at Week 52

*OSPHENA® was studied in a 52-week randomized, double-blind, placebo-controlled, long-term safety study that also was conducted with 2 treatment groups: OSPHENA® 60 mg (n=363) and placebo (n=63). OSPHENA® should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.

References: 1. Data on file. Shionogi Inc. 2. Osphena [package insert]. Florham Park, NJ: Shionogi Inc; 2015.

Safety data from one of the largest clinical trial programs
For moderate to severe dyspareunia due to menopause1,2

Phase 2/3 Trials

Up to

Weeks in Duration

Postmenopausal Women Studied

409 postmenopausal women were studied for up to 52 weeks

Adverse reactions in clinical trials reported at a frequency of ≥1% and more common in the OSPHENA® 60-mg group1 OSPHENA 60 mg (n=1242) PLACEBO
(n=958)
Vascular Disorders Hot Flush 7.5% 2.6%
Reproductive System
and Breast Disorders
Vaginal Discharge
Genital Discharge
3.8%
1.8%
0.3%
0.1%
Musculoskeletal and
Connective Tissue Disorders
Muscle Spasms 3.2% 0.9%
Skin and Subcutaneous
Tissue Disorders
Hyperhidrosis 1.6% 0.6%
  • Discontinuation rates with OSPHENA due to hot flush were <1%2
  • Discontinuation rates due to treatment-emergent adverse events with OSPHENA (7.6%) were
    similar to placebo (3.7%)2

References 1. Osphena® [package insert]. Florham Park, NJ: Shionogi Inc; 2015. 2. Data on file. Shionogi Inc.

OSPHENA® Savings Program Offers

2 ways to save*

On OSPHENA prescriptions

So your patient can get the treatment she needs.

Savings Card

For Monthly

prescriptions

Most patients with insurance get their
first and fourth month free and may
pay as little as $25*
for other monthly refills.

View Details

For 3-Month

prescriptions

Most patients with insurance may
pay as little as $50*
for a 3-month supply.

View Details

*Some restrictions apply. The Osphena® Savings Card is not available to Medicare Part D, Medicaid, or other federal or state insurance program participants.
See eligibility rules and full program terms and conditions, including maximum benefit, on the Savings Card.

Get your patients started with the
OSPHENA patient sample kit, including:

  • 30 Tablets
  • Patient Education
  • Support Program Information

Looking for support for your patients?

Here's an exclusive invitation for your patients to join the

When your patients join the Inner Circle, they will receive a monthly newsletter, tips, and refill reminders. They also will have easy access to the OSPHENA Savings Program.

Your patients can join today at

OSPHENA.com/innercircle

mailbox

OSPHENA At Home

For patients who would like OSPHENA delivered to their doors.

Download PDF

phone

Nurse Call Center

For answers to patients'
questions about OSPHENA.

Learn More

brochure

Patient Education Brochure

For helpful patient information
about OSPHENA.

Download PDF

documents

Patient Tear Pad

A handy tear-off pad with helpful information for your OSPHENA patients.


Download PDF


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Indication

Osphena® (ospemifene) is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Important Safety Information for Osphena

WARNING: Endometrial Cancer and Cardiovascular Disorders

Osphena is an estrogen agonist/antagonist with tissue selective effects. In the endometrium Osphena has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogen therapy. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

The Women’s Health Initiative (WHI) estrogen-alone substudy reported an increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg], relative to placebo. Osphena 60 mg had thromboembolic and hemorrhagic stroke incidence rates of 0.72 and 1.45 per thousand women vs. 1.04 and 0 per thousand women for placebo and a DVT incidence rate of 1.45 vs. 1.04 per thousand women for placebo. Osphena should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.

Contraindications

  • Undiagnosed abnormal genital bleeding
  • Known or suspected estrogen-dependent neoplasia
  • Active deep vein thrombosis (DVT), pulmonary embolism (PE), or a history of these conditions
  • Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions
  • Hypersensitivity (for example, angioedema, urticaria, rash, pruritus) to Osphena or any of its ingredients
  • Women who are or may become pregnant. Osphena may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m2. If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.

Warnings and Precautions

In Osphena clinical trials of up to 15 months, the incidence rates compared to placebo for thromboembolic and hemorrhagic stroke were 0.72 Osphena 60 mg vs. 1.04 placebo and 1.45 Osphena 60 mg vs. 0 placebo per thousand women. Should thromboembolic or hemorrhagic stroke occur or be suspected, Osphena should be discontinued immediately. In clinical trials, a single MI occurred in a woman receiving Osphena 60 mg.

Incidence rate of DVT was 1.45 Osphena vs. 1.04 placebo per thousand women. Should a VTE occur or be suspected, Osphena should be discontinued immediately. Osphena should be discontinued at least 4 to 6 weeks before surgery with increased risk of thromboembolism or during periods of prolonged immobilization.

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogen therapy. The risk appears dependent on duration of treatment and estrogen dose. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. However, studies suggest a possible increased risk for breast cancer in patients receiving estrogen plus progestin therapy.

Osphena is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, Osphena has agonistic effects. In Osphena clinical trials, no cases of endometrial cancer were seen with exposure up to 52 weeks. There was a single case of simple hyperplasia without atypia. Endometrial thickening equal to 5mm or greater was reported at a rate of 60.1 Osphena vs. 21.2 placebo per 1000 women. Uterine polyps occurred at an incidence of 5.9 Osphena vs. 1.8 placebo per 1000 women, and any type of proliferative endometrium (weakly plus active plus disordered) was 86.1 Osphena vs. 13.3 placebo per 1000 women.

Osphena has not been adequately studied in women with breast cancer; therefore it should not be used in women with known or suspected breast cancer or with a history of breast cancer.

Osphena should not be used in women with severe hepatic impairment as it has not been studied.

In clinical trials the more commonly reported adverse reactions in ≥1 percent of patients treated with Osphena 60 mg compared to placebo were: hot flush (7.5% vs. 2.6%), vaginal discharge (3.8% vs. 0.3%), muscle spasms (3.2% vs. 0.9%), hyperhidrosis (1.6% vs. 0.6%), and genital discharge (1.3% vs. 0.1%).

The following adverse reactions have been identified during post-approval use of ospemifene:
Immune System Disorders: allergic conditions including hypersensitivity, angioedema.
Skin and Subcutaneous Tissue Disorders: rash, rash erythematous, rash generalized, pruritus, urticaria.

Drug interactions: Do not use estrogens or estrogen agonists/antagonists, fluconazole, or rifampin concomitantly with Osphena. Co-administration of Osphena with drugs that inhibit CYP3A4 and CYP2C9 may increase the risk of Osphena-related adverse reactions. Osphena is highly protein bound. Use cautiously with highly protein bound drugs as use with other highly protein-bound drugs may lead to increase exposure of that drug or ospemifene.

Please click for U.S. Full Prescribing Information for Osphena® (ospemifene) tablets, including Boxed WARNING, and Patient Information.