Reduce frequency, severity of moderate-to-severe hot flashes: Evamist efficacy

You can give her relief in a mist. Evamist™ reduces the frequency and severity of moderate-to-severe hot flashes by 69% and 41%, respectively.¹

Find out more about:

Reductions in frequency

Reductions in severity

Sustained delivery

Relief that increases over time

Evamist significantly reduces frequency of moderate-to-severe vasomotor symptoms

With Evamist, patients experience relief that increases as they continue therapy with Evamist.² Change in vasomotor symptoms was measured from baseline in a pivotal Phase III trial. By Week 4, patients reported a >50% reduction in hot flashes, and by Week 12, they experienced a 69% reduction in the frequency of moderate-to-severe hot flashes.¹

	At Week 12, 1 spray of Evamist significantly reduced the frequency of hot flashes by 69% (from 11.81 to 3.71) vs 38% (from 12.41 to 7.65) with placebo (P=0.0004)¹
	Hot flash reductions were statistically significant for all 3 doses of Evamist by Week 4 (P<0.01 vs placebo)¹

Change from baseline (intent-to-treat population) in the frequency of moderate-to-severe hot flashes in a pivotal Phase III, randomized, multicenter, double-blind, placebo-controlled study (N=454). Reductions at Weeks 4 and 12 were co-primary endpoints. Reductions at Week 8 were a secondary endpoint.^1,2

Reduction vs placebo at Week 1 was not statistically significant.

^†

P values for Evamist vs placebo at Week 1: P=0.0874, Week 2: P=0.0320,
Week 4: P=0.0010, Week 8: P=0.0001, Week 12: P=0.0004.

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Evamist significantly reduces the severity of moderate-to-severe hot flashes¹

In the same Phase III study, women using 1 spray per day had a 41% reduction in the severity of hot flashes they experienced.¹

Change from baseline (intent-to-treat population) in the severity of moderate-to-severe hot flashes in a pivotal Phase III, randomized, multicenter, double-blind, placebo-controlled study (N=454). Severity score calculated as: (2 x number of moderate hot flashes + 3 x number of severe hot flashes) / (number of moderate hot flashes + number of severe hot flashes).¹

Reductions in hot flash severity were statistically significant by Week 5 with 1 spray/day (P=0.0034 vs placebo)²

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Sustained delivery of estradiol¹

Evamist provides sustained delivery of estradiol.¹ In a clinical study, serum levels of Evamist after an 8 AM dose were found to peak between the hours of 2 AM and 6 AM.²

In a single-center, randomized, open-label, parallel-group study, 24 healthy postmenopausal women were randomly assigned to receive one spray of Evamist applied to the inner forearm of the same arm once daily at 8 AM for 14 days.^1,2

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Evamist delivers increasing relief over time²

By four weeks your patients should expect to experience a greater than 50% reduction in the frequency of their moderate-to-severe vasomotor symptoms.¹

Reductions continue over time:
	53% at Week 4
	69% at Week 12

Change from baseline (intent-to-treat population) in the frequency of moderate-to-severe hot flashes per week in a pivotal Phase III, randomized, multicenter, double-blind, placebo-controlled study (N=454). Reductions at Weeks 4 and 12 were co-primary endpoints. Reductions at Week 8 were a secondary endpoint.^1,2

Reduction vs placebo at Week 1 was not statistically significant.

^†

P values for Evamist vs placebo at Week 1: P=0.0874, Week 2: P=0.0320,
Week 4: P=0.0010, Week 8: P=0.0001, Week 12: P=0.0004.

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In a clinical trial with Evamist, the most common side effects were headache, breast tenderness, nasopharyngitis, nipple pain, back pain, nausea, and arthralgia.

Clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Evamist should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.

» Footnote References

Important Safety Information

Indication

Evamist is indicated for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

WARNING—ENDOMETRIAL CANCER, CARDIOVASCULAR, AND OTHER RISKS

ENDOMETRIAL CANCER Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

CARDIOVASCULAR AND OTHER RISKS Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with daily oral conjugated estrogens (CE 0.625 mg), relative to placebo. The estrogen plus progestin WHI substudy reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. The Women’s Health Initiative Memory Study (WHIMS), a substudy of the WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Evamist should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.

In a clinical trial with Evamist, the most common side effects were headache, breast tenderness, nasopharyngitis, nipple pain, back pain, nausea, and arthralgia.

Please see full prescribing information for Evamist, including boxed warnings.