What is the only FDA approved NH treatment for VMS and the only one with Efficacy and Tolerability at a 7.5mg dose that is NOT for psych conditions.
100
What was first evaluated and seen at 4 weeks
What is Onset of action
100
% of patients that experienced headache (___), fatigue (___) and nausea (___).
What is headache (6.3%), fatigue (4.9%) and nausea (4.3%)
100
606
What is the number of patients in Study 1
100
What is the cost/insurance coverage for this product?
What is widely covered my most insurance plans (90%), lets take a look at your specific geographic location. Co-pay card which allows the patient to pay as little as $25 for their Rx
200
For VMS I am dosed...
What is 7.5 mg QD at night
200
zero _______ gain and no ________ dysfunction
What is weight gain and no sexual dysfunction
200
Most common AE's leading to discontinuation
What are Abdominal Pain (0.3%)
Attention Disturbances (0.3%)
Headache (0.3%)
Suicidal Ideation (0.3%)
200
Study 1 - Statistically significant change in severity of VMS at weeks
What is weeks 4 and 12
200
Why not rx the generic
What is only approved FDA approved, first and only VMS of it's kind, NH, efficacy and unique 7.5mg dose that is not for depression
300
Titration schedule for discontinuation is
What is no titration is needed
300
Primary endpoints of these two Phase 3 studies
What are co-primary endpoints for the two Phase 3 studies were, reduction from baseline in m to s VMS frequency and severity at weeks 4 and 12. Additional endpoint was persistence of treatment benefit at week 24
300
Signs of serotonin syndrome
What are racing heartbeat, agitation, muscle twitching, sweating, fever, nausea, vomiting or diarrhea, muscle rigidity, dizziness flushing, tremors, seizures
300
Define persistence of benefit - what was demonstrated at week 24
What is greater than or equal to 50% reduction from baseline inn the frequency of moderate to severe VMS. 48% of the product patients vs. 36% with Placebo
300
It's nothing new - Paroxetine is old and in the past plus... It causes many side effects
Bdelle was specifically studied at a unique 7.5 mg dose that is not indicated for the treatment of any psych conditions. It is the first and ONLY FDA approved, non-hormonal option with a unique 7.5mg dose that balances proven tolerability and is not an anti-depressant.
400
$25 and $75
What is co-pay card for eligible patients and discount for cash patients
400
Patients may expect an average of __% reduction of their hot flashes at week 4, and an average of __% reduction by week 12, based on a __ month clinical trial, and those hot flashes they still have may be less severe.
40% by week 4
60% by week 12
6-month clinical trial
400
Contraindications include
What are MAOI use with 14 days
Thioridazine
Pimozide
Hypersensitivity to any ingredient
Pregnancy
400
Study 2 - number of patients, % of surgical vs. natural, average age
What is 568, 20% surgical vs. 81% natural, 54
400
How is Ptine 7.5mg different from 10mg
What is FDA approved, safe and effective non-hormonal, it is specifically developed and studied to treat moderate to severe VMS at a unique 7.5 mg dose that balances efficacy AND tolerability. It is NOT approved for psychiatric conditions, lowest effective dose.
500
Three patient types appropriate for therapy
Who are those that cannot or will not take hormone therapy, those that discontinued hormone therapy and remain symptomatic and those who are early at menopause
500
Three patient types appropriate for therapy
Who are those that cannot or will not take hormone therapy, those that discontinued hormone therapy and remain symptomatic and those who are early at menopause
500
11 Warnings
What are, Suicidal Thoughts & Behaviors
Serotonin Syndrome
Tamoxifen Efficacy
Abnormal Bleeding
Angle Closure Glaucoma
Hyponatremia
Bone Fracture
Screening for Bipolar
Seizures
Akathisia
Potential for cognitive and motor impairment
500
If a patient needs this product for psychiatric treatment they should
What is should discontinue product and initiate a product containing medication that is indicated for such use
500
How do I switch my patients from a higher dose of Paroxetine or another SSRI or SNRI
What is studies did not specifically examine the safety or efficacy of switching patients. Please consider your patient's current drug's labeling directions for discontinuation or tapering with evaluating a switch.