The Brisdelle NDC number changed to #54766-907-53 in November 2017

Why Brisdelle®?

Is non-hormonal Brisdelle right for your patients?

Brisdelle is the only nonhormonal therapy

Brisdelle is the only branded non-hormonal therapy approved by the FDA for moderate to severe hot flashes due to menopause.1

Brisdelle balances

Brisdelle balances effective relief with proven tolerability at a 7.5 mg dose.1

Brisdelle is part of a class

Brisdelle is part of the class of SSRI medicines, but is not an antidepressant treatment.1

A significant reduction in frequency and severity of vasomotor symptoms (VMS) associated with menopause has been shown at 30 days with BRISDELLE, and it may take your patients a FULL 90 DAYS to realize their optimal reduction in VMS frequency and severity.1

Brisdelle Timeline
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Brisdelle® Efficacy, Safety, and Tolerability

Reduction in frequency of moderate to severe hot flashes at Weeks 4 and 12 (MITT population).1

Results of 24-week study are shown above.

MITT population: all consented and randomized subjects with valid baseline daily hot flash diary data who had taken at least 1 dose of study medication and had a least 1 day of on treatment daily hot flash diary data.

•P-value is obtained from rank-ANCOVA model.

Study design: Two randomized, double-blind, placebo-controlled, Phase 3 clinical trials evaluated the co-primary endpoints of change from baseline in the frequency and severity of moderate to severe hot flashes at Weeks 4 and 12 in patients taking Brisdelle vs placebo. In the 2 studies, 7 of 8 of the co-primary endpoints were met. One study was continued for 24 weeks to measure persistence of benefit.1

Brisdelle® (paroxetine) 7.5 mg

The first FDA-approved, non-hormonal treatment.

  • BRISDELLE® (paroxetine) provides relief with menopausal moderate to severe VMS at Weeks 4 and 12
  • Average 40% reduction from baseline in number of VMS at Week 4
  • Average 60% reduction from baseline in number of VMS at Week 121

Persistence of benefit at Week 24

  • 48% of women taking BRISDELLE experienced a ≥50% reduction from baseline in frequency of moderate to severe VMS at Week 24 vs 36% of women taking placebo.
  • Persistence of benefit beyond 12 weeks is a requirement for FDA approval of a non-hormonal drug.1

Brisdelle® (paroxetine) 7.5 mg

The first FDA-approved, non-hormonal treatment.

  • BRISDELLE® (paroxetine) provides relief with menopausal moderate to severe VMS at Weeks 4 and 12
  • Average 40% reduction from baseline in number of VMS at Week 4
  • Average 60% reduction from baseline in number of VMS at Week 121

Persistence of benefit at Week 24

  • 48% of women taking BRISDELLE experienced a ≥50% reduction from baseline in frequency of moderate to severe VMS at Week 24 vs 36% of women taking placebo.
  • Persistence of benefit beyond 12 weeks is a requirement for FDA approval of a non-hormonal drug.1

Reduction in frequency of moderate to severe hot flashes at Weeks 4 and 12 (MITT population).1

Results of 24-week study are shown above.

MITT population: all consented and randomized subjects with valid baseline daily hot flash diary data who had taken at least 1 dose of study medication and had a least 1 day of ontreatment daily hot flash diary data.

•P-value is obtained from rank-ANCOVA model.

Study design: Two randomized, double-blind, placebo-controlled, Phase 3 clinical trials evaluated the co-primary endpoints of change from baseline in the frequency and severity of moderate to severe hot flashes at Weeks 4 and 12 in patients taking Brisdelle vs placebo. In the 2 studies, 7 of 8 of the co-primary endpoints were met. One study was continued for 24 weeks to measure persistence of benefit.1


BRISDELLE TOLERABILITY: BALANCED WITH PROVEN TOLERABILITY AT A 7.5 mg DOSE

Please see complete important safety information below, including warning about suicidal thoughts and behaviors. Other important warnings include risk of developing serotonin syndrome, reduced effectiveness of tamoxifen, and abnormal bleeding, hyponatremia, bone fracture, activation of mania/hypomania, seizures, akathisia, acute angle closure glaucoma, cognitive/motor impairments.1

ADVERSE REACTIONS

The most common adverse reactions (>2% and at a higher incidence than placebo) reported in clinical trials were: headache, fatigue, and nausea/vomiting. Of these, nausea occurred primarily within the first 4 weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy.1

Discontinuation rates due to AEs were similar to those with placebo (4.7% with Brisdelle vs. 3.7% with placebo).1

Only 3 types of common adverse reactions (>2% and a higher incidence than placebo) were seen in clinical trials.1

BRISDELLE TOLERABILITY
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Dosing

Only 3 types of common adverse reactions (>2% and a higher incidence than placebo) were seen in clinical trials.1

BRISDELLE TOLERABILITY

BRISDELLE TOLERABILITY: BALANCED WITH PROVEN TOLERABILITY AT A 7.5 mg DOSE

Please see complete important safety information below, including warning about suicidal thoughts and behaviors. Other important warnings include risk of developing serotonin syndrome, reduced effectiveness of tamoxifen, and abnormal bleeding, hyponatremia, bone fracture, activation of mania/hypomania, seizures, akathisia, acute angle closure glaucoma, cognitive/motor impairments.1

ADVERSE REACTIONS

The most common adverse reactions (>2% and at a higher incidence than placebo) reported in clinical trials were: headache, fatigue, and nausea/vomiting. Of these, nausea occurred primarily within the first 4 weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy.1

Discontinuation rates due to AEs were similar to those with placebo (4.7% with Brisdelle vs. 3.7% with placebo).1

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Dosing

The FDA-approved Brisdelle dose: 7.5 mg

The only branded non-hormonal FDA-approved treatment for moderate to severe vasomotor symptoms of menopause

Brisdelle, with its 7.5 mg dose, was the first non-hormonal medication on the market that was designed and studied with the treatment of menopausal vasomotor symptoms in mind. Brisdelle is approved by the FDA for treatment of vasomotor symptoms in menopause.1

  • Just one 7.5 mg capsule once a day
    Administer at bedtime, with or without food.1
  • No up or down titration
    Requires no dose adjustment.1
  • No titration to discontinue
    Can be stopped without the need for titration.1

Make sure your patients get what you have prescribed by writing “DAW”

Dispense as written

Please include "DAW" or "Dispense as written" on every prescription

  • Guard against substitution at your patient's pharmacy.
  • Reassure patients that with Brisdelle they are getting proven efficacy/ tolerability specifically for the treatment of moderate to severe hot flashes due to menopause.1
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Prescribing Brisdelle®

The FDA-approved Brisdelle dose: 7.5 mg

The only branded non-hormonal FDA-approved treatment for moderate to severe vasomotor symptoms of menopause

Brisdelle, with its 7.5 mg dose, was the first non-hormonal medication on the market that was designed and studied with the treatment of menopausal vasomotor symptoms in mind. Brisdelle is approved by the FDA for treatment of vasomotor symptoms in menopause.1

  • Just one 7.5 mg capsule once a day
    Administer at bedtime, with or without food.1
  • No up or down titration
    Requires no dose adjustment.1
  • No titration to discontinue
    Can be stopped without the need for titration.1

Make sure your patients get what you have prescribed by writing “DAW”

Please include "DAW" or "Dispense as written" on every prescription

  • Guard against substitution at your patient's pharmacy.
  • Reassure patients that with Brisdelle they are getting proven efficacy/ tolerability specifically for the treatment of moderate to severe hot flashes due to menopause.1
Dispense as written
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Prescribing Brisdelle®

To help you and your patients

Brisdelle® resources for the treatment of moderate to severe vasomotor symptoms.

Help patients SAVE with Brisdelle.®
Pay as little as $25 for a 90 day supply.

*For eligible patients only.
See offer for the full terms and conditions.

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Patient Profiles:
3 Different Women, 3 Different Challenges

  • Patient Challenge 1:

    Patient Challenge 1

    For appropriate patients TREATMENT: Brisdelle non-hormonal relief when she cannot or will not take hormone therapy.



    This does not mean that Brisdelle as a non-hormonal treatment is safer or more effective than hormonal therapies. The safety and efficacy of Brisdelle compared with hormone therapies have not been studied.




  • Patient Challenge 2:

    For appropriate patients TREATMENT: Brisdelle non-hormonal relief when she discontinued hormone therapy and is symptomatic.

    Observational studies found that:

    40% to 50% of women who started hormone therapy quit within 1 year.4


    The safety and efficacy of Brisdelle compared with hormone therapies have not been studied. Brisdelle is a non-hormonal treatment option.1


    Untreated women continue to have hot flashes well after reaching menopause.5,6


    Patient Challenge 2

  • Patient Challenge 3:

    Patient Challenge 3

    For appropriate patients TREATMENT: Brisdelle non-hormonal relief of hot flashes when she is early at menopause.

    According to recent studies, moderate to severe hot flashes can persist for 4.5 years or more.5,6


    At menopause* she’s likely to experience moderate to severe hot flashes first.


    *The average age of menopause is 51.


    Brisdelle is not indicated to treat moderate to severe hot flashes before reaching menopause.



  • Patient Challenge 1:

    Patient Challenge 1

    For appropriate patients TREATMENT: Brisdelle non-hormonal relief when she cannot or will not take hormone therapy.



    This does not mean that Brisdelle as a non-hormonal treatment is safer or more effective than hormonal therapies. The safety and efficacy of Brisdelle compared with hormone therapies have not been studied.



  • Patient Challenge 2:

    Patient Challenge 2

    For appropriate patients TREATMENT: Brisdelle non-hormonal relief when she discontinued hormone therapy and is symptomatic.

    Observational studies found that:

    40% to 60% of women who started hormone therapy quit within 1 year.4


    The safety and efficacy of Brisdelle compared with hormone therapies have not been studied. Brisdelle is a non-hormonal treatment option.1


    Untreated women continue to have hot flashes well after reaching menopause.5,6


  • Patient Challenge 3:

    Patient Challenge 3

    For appropriate patients TREATMENT: Brisdelle non-hormonal relief of hot flashes when she is early at menopause.

    According to recent studies, moderate to severe hot flashes can persist for 4.5 years or more.5,6


    At menopause* she’s likely to experience moderate to severe hot flashes first.


    *The average age of menopause is 51.


    Brisdelle is not indicated to treat moderate to severe hot flashes before reaching menopause.


BRISDELLE (paroxetine) is the only branded FDA-approved non-hormonal therapy for the treatment of moderate to severe hot flashes associated with menopause. Consider the Boxed Warning for Suicidal Thoughts and Behaviors as well as the contraindications and Important Safety Information.

BRISDELLE:

  • Reduces the frequency and severity of moderate to severe hot flashes.
  • Is balanced with proven tolerability.
  • Has a 7.5 mg dose that is not an antidepressant treatment.
FAQ

For any questions about Brisdelle

Call: 888-246-1207

FAQ

For any questions about Brisdelle

Call: 888-246-1207

IMPORTANT SAFETY INFORMATION


WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

  • Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders. Because BRISDELLE is an SSRI, monitor patients closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.


CONTRAINDICATIONS:

  • Concurrent use with monoamine oxidase inhibitors (MAOIs)
    • - or use within 14 days of MAOI use
    • - or starting BRISDELLE in a patient who is being treated with linezolid
    • - or intravenous methylene blue
    • Because of an increased risk of serotonin syndrome.
  • Concomitant use with thioridazine or pimozide due to their increased plasma concentrations and because of the potential of QTc prolongation.
  • Hypersensitivity to any ingredient in BRISDELLE.
  • Pregnancy because BRISDELLE may cause fetal harm.


WARNINGS AND PRECAUTIONS:

  • Suicidality: All patients being treated with BRISDELLE should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment.
  • Serotonin Syndrome: Serotonin syndrome, which is potentially life-threatening, has been reported with concomitant use of serotonergic drugs, and with drugs that impair metabolism of serotonin (in particular, MAOIs). Monitor patients for the emergence of serotonin syndrome. Discontinue BRISDELLE and any concomitant serotonergic agents and initiate supportive treatment.
  • Tamoxifen: Efficacy of tamoxifen may be reduced when administered concomitantly with BRISDELLE.
  • Abnormal Bleeding: SSRIs, including BRISDELLE, may increase the risk of bleeding events. Caution patients about the risk of bleeding associated with the concomitant use of BRISDELLE and non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation.
  • Angle Closure Glaucoma: Angle-closure glaucoma has occurred in patients treated with antidepressants with untreated anatomically narrow angles
  • Hyponatremia: may occur as a result of treatment with SSRIs, including BRISDELLE. Elderly patients may be at greater risk and in many cases it can occur in association with syndrome of inappropriate antidiuretic hormone secretion (SIADH). Consider discontinuation of BRISDELLE in patients with symptomatic hyponatremia and institute appropriate medical intervention.
  • Bone fracture: Epidemiological studies have reported an association between SSRI treatment and fractures.
  • Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/ hypomania.
  • Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.
  • Akathisia: Can occur, most likely in the first few weeks of treatment. Discontinue treatment with BRISDELLE if akathisia occurs.
  • Cognitive and Motor Impairment: May cause impairment; patients should not operate machinery or motor vehicles until certain that BRISDELLE does not affect them adversely.


ADVERSE REACTIONS:

The most common adverse reactions (≥ 2%) reported in clinical trials were: headache, fatigue, and nausea and vomiting. Of these, nausea occurred primarily within the first 4 weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy.


To report SUSPECTED ADVERSE REACTIONS, contact Sebela Pharmaceuticals Inc. at 888-271-4621 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch


DRUG INTERACTIONS:

Paroxetine is a strong CYP2D6 inhibitor. Co-administration of BRISDELLE can alter concentrations of other drugs that are metabolized by CYP2D6. Use caution if coadministering BRISDELLE with other drugs that are metabolized by CYP2D6.


INDICATION

BRISDELLE® (paroxetine) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.


BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE contains a lower dose of paroxetine than that used for psychiatric conditions. The safety and efficacy of this lower dose of paroxetine in BRISDELLE have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing medication that is indicated for such use.


These are not all the possible side effects of BRISDELLE. Please read the full Prescribing Information including Boxed WARNING and patient Medication Guide.


BRISDELLE® is a registered trademark of Sebela Pharmaceuticals Inc.


REREFENCES: 1. Brisdelle [Prescribing Information]. Roswell, GA: Sebela Pharmaceuticals Inc.; 2017. 2. Grady D, Sawaya GF. Discontinuation of postmenopausal hormone therapy. Am J Med. 2005;118(suppl 12B):163S-165S. 3. Avis NE, Crawford DL, Greendale G, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015;175(4):531-539. 4. Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014;21(9):924-932.