Is her sexual desire diminished?
Is it causing her distress?
Ask her!1
PrADDYI® (flibanserin) is indicated for the treatment of premenopausal and naturally postmenopausal women ≤ 60 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire for a minimum of 6 months, which occurs 75-100% of the time, that causes marked distress or interpersonal difficulty and is NOT due to:2
- a co-existing medical or psychiatric condition,
- problems within the relationship, or
- the effects of a medication or other drug substance.
“Acquired”: no previous problem with sexual desire. “Generalized”: regardless of the type of stimulation, situation or partner.
Limitations of use2
- ADDYI is not indicated for use in men.
- ADDYI is not indicated to enhance sexual performance.
HSDD is a condition that has been medically recognized for nearly half a century. It is the most common form of female sexual dysfunction, but frequently undiagnosed.1
For more information about HSDD history, diagnosis and treatment, please refer to the (SOGC) Female Sexual Health Consensus Clinical Guidelines.4
This is Addyi® 
A Little Pink Pill* * Not actual size
*Comparative clinical significance has not been established.
The Coversation Begins With a Validated Screener
As her healthcare provider, it’s important for you to lead the dialogue relating to her concerns about her hypoactive sexual desire. Screening for HSDD can be done in a timely way using the Decreased Sexual Desire Screener (DSDS). This is a validated medical questionnaire with just 5 questions.5
Once the diagnosis has been established, and the patient has expressed a desire for treatment, it is important to evaluate whether ADDYI is suitable for the patient. The Prescriber’s Checklist facilitates this. The pharmacy can confirm the patient’s eligibility for treatment by using The Pharmacist’s Checklist.
ADDYI studies in premenopausal women– overview2§
Three 6-month, randomized, double-blind, placebo-controlled studies of 3,548 premenopausal HSDD patients aged 19-55*
SUPPORTING STUDY 1
ADDYI 100 mg qhs, n=290
Placebo qhs, n=295
SUPPORTING STUDY 2
ADDYI 50 mg qhs uptitrated to 100 mg qhs after 14 days, n=395
Placebo qhs and bid, n=398†
PIVOTAL STUDY
ADDYI 100 mg qhs, n=542
Placebo qhs, n=545
CO-PRIMARY ENDPOINT 1: Sexual Desire‡
Supporting studies – e-Diary:
(Daily patient rating of sexual desire, where 0=no; 3=strong desire, summed up for a monthly sexual desire score)
Pivotal study – Female Sexual Function Index-Desire (FSFI-D):
(Over the past 4 weeks, how often did you feel sexual desire or interest, where 1=almost never or never; 5=almost always or always?
Over the past 4 weeks, how would you rate your level (degree) of sexual desire or interest, where 1=very low or none at all; 5=very high?)
CO-PRIMARY ENDPOINT 2: Satisfying Sexual Events (SSE)‡
(Did you have a sexual event? Was the sex satisfying for you?)
SECONDARY ENDPOINT: Bother (component of distress)
(FSDS-R: In the last 7-day period, how often did you feel bothered by low sexual desire, where 0=never; 4=always?)
* Patients were white 88.6%, black 9.6%, Asian 1.5%; mean age 36. Completion rate: 70% ADDYI;
78% placebo. A total of 1,227 patients received ADDYI and 1,238 patients received placebo.
†50 mg qhs dosing used in supporting study 2 is not the recommended dosing for ADDYI.
‡Co-primary endpoints evaluated for change from baseline to Week 24.
ADDYI SUPPORTING STUDIES – RESULTS2§
| Supporting Study 1 | Supporting Study 2 | |||
|---|---|---|---|---|
| ADDYI (100 mg qhs) n=290 |
Placebo n=295 | ADDYI (100 mg qhs) n=395 |
Placebo n=398 | |
| Number of SSEs (Satisfying Sexual Events) standardized to 28 days | ||||
| Baseline | 3.0 | 2.7 | 2.6 | 2.7 |
| Week 24 | 4.6 | 3.5 | 4.4 | 3.7 |
| Change from baseline | 1.6 | 0.8 | 1.9 | 1.1 |
| p-value vs placebo | p=0.002 | p=0.008 | ||
| FSFI-D (Female Sexual Function Index – desire domain) | ||||
| Baseline | 3.0 | 2.7 | 2.6 | 2.7 |
| Week 24 | 4.6 | 3.5 | 4.4 | 3.7 |
| Change from baseline* | 1.6 | 0.8 | 1.9 | 1.1 |
| p-value vs placebo | p=0.002 | p=0.008 | ||
| e-Diary | ||||
| Baseline | 12.9 | 11.8 | 12.0 | 10.2 |
| Week 24 | 21.2 | 18.1 | 20.1 | 16.9 |
| Change from baseline* | 9.1 | 6.9 | 8.5 | 6.8 |
| p-value vs placebo | NS | NS | ||
| FSDS-R Question 13 (Female Sexual Distress Scale-revised version) | ||||
| Baseline | 3.2 | 3.2 | 3.3 | 3.2 |
| Week 24 | 2.4 | 2.7 | 2.5 | 2.7 |
| Change from baseline* | -0.8 | -0.5 | -0.7 | -0.5 |
| p-value vs placebo | p=0.0001 | p=0.0006 | ||
NS = not significant
ADDYI PIVOTAL STUDY IN PREMENOPAUSAL WOMEN – DEMONSTRATED EFFICACY IN 3 ENDPOINTS
Women with HSDD treated with ADDYI 100 mg qhs showed statistically significant differences from placebo for sexual desire (FSFI-D – Female Sexual Function Index – desire domain), satisfying sexual events per 28 days, and distress (FSDS-R Question 13 – Female Sexual Distress Scale-revised version) after 8 weeks of treatment, and these differences were sustained over the 24-week treatment period.
Primary endpoint: Baseline: ADDYI; 2.5 Placebo: 2.7. Change from baseline: ADDYI 2.5; Placebo 1.5.
Associated distress (FSDS-R Question 13) was DECREASED vs. placebo2,6§
Secondary endpoint: change from baseline: ADDYI -1.0; Placebo -0.7
Item 13 specifically assesses bother (a component of distress) related to low sexual desire.
Number of satisfying sexual events (SSEs) were INCREASED vs. placebo2,6§
Primary endpoint: change from baseline: ADDYI 2.5; Placebo 1.5.
SSEs (satisfying for patient) included sexual intercourse, oral sex, masturbation, or genital stimulation by a partner
ADDYI study in postmenopausal women – overview2§
6-MONTH, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF 947 POSTMENOPAUSAL HSDD PATIENTS (MEAN AGE 56)*†
PIVOTAL STUDY
ADDYI 100 mg qhs, n=467
Placebo qhs, n=480
CO-PRIMARY ENDPOINT 1: Sexual Desire‡
Pivotal study – Female Sexual Function Index-Desire (FSFI-D):
(Over the past 4 weeks, how often did you feel sexual desire or interest, where 1=almost never or never; 5=almost always or always?
Over the past 4 weeks, how would you rate your level (degree) of sexual desire or interest, where 1=very low or none at all; 5=very high?)
CO-PRIMARY ENDPOINT 2: Satisfying Sexual Events (SSE)‡
(Did you have a sexual event? Was the sex satisfying for you?)
SECONDARY ENDPOINT: Bother (component of distress)
(FSDS-R: In the last 7-day period, how often did you feel bothered by low sexual desire, where 0=never; 4=always?)
* Patients were white 91.8%, black 6.5%, and Asian 0.8%; mean age 56; 83% were <60 years of age. Completion rate: 78% ADDYI; 83% placebo. A total of 467 patients received ADDYI and 480 patients received placebo.
† ADDYI is not indicated for postmenopausal women over the age of 60.
‡ Co-primary endpoints evaluated for change from baseline to Week 24.
ADDYI PIVOTAL STUDY IN POSTMENOPAUSAL WOMEN – DEMONSTRATED EFFICACY IN 3 ENDPOINTS
Women with HSDD treated with ADDYI 100 mg qhs showed statistically significant differences from placebo for SSEs standardized per 28 days, and sexual desire (FSFI-D), and distress (FSDS-R13). Significant differences between placebo and treatment values were seen after 4 or 8 weeks of treatment and were generally sustained over the 24-week treatment period.
ADDYI PIVOTAL STUDY – RESULTS2§
| Pivotal Study | |||
|---|---|---|---|
| ADDYI (100 mg qhs) n=467 | Placebo n=480 | ||
| Number of SSEs (Satisfying Sexual Events) standardized to 28 days | |||
| Baseline | 2.1 | 2.0 | |
| Week 24 | 3.2 | 2.8 | |
| Change from baseline | 1.8 | 0.8 | |
| p-value vs placebo | p=0.0194 | ||
| FSFI-D (Female Sexual Function Index – desire domain) | |||
| Baseline | 1.8 | 1.8 | |
| Week 24 | 2.5 | 2.2 | |
| Change from baseline* | 0.7 | 0.4 | |
| p-value vs placebo | p<0.0001 | ||
| FSDS-R Question 13 (Female Sexual Distress Scale-revised version) | |||
| Baseline | 3.3 | 3.3 | |
| Week 24 | 2.5 | 2.7 | |
| Change from baseline* | -0.8 | -0.6 | |
| p-value vs placebo | p=0.0083 | ||
§ Table and graphs adapted from the ADDYI product monograph.2
Efficacy results are based on the full analysis set comprised of all randomized patients who took at least one dose of study medication and had at least one on-treatment efficacy assessment.
Missing values were imputed using last observation carried forward method.
* The unadjusted means (standard deviation) are presented for the baseline and week-24 values. For SSE, p-values are based on the Wilcoxon rank-sum test stratified by pooled center, and the change from baseline mean (standard deviation) are presented for the change from baseline. For all other endpoints, p-values are based on an ANCOVA (analysis of covariance) model using baseline as a covariate with main effect terms treatment and pooled center. For the change from baseline, the adjusted least-squares mean (standard error) are presented.2
Adverse Reactions2
Most common adverse reactions occurring in ADDYI clinical studies in premenopausal women
| Placebo (n=1,905) | ADDYI (n=1,543) | |
|---|---|---|
| Dizziness | 2.2% | 11.4% |
| Somnolence | 3.1% | 11.2% |
| Nausea | 3.7% | 10.4% |
| Fatigue | 5.0% | 9.2% |
Adapted from the ADDYI product monograph.2
The majority of these adverse reactions emerged in the first 14 days of treatment and were of mild to moderate intensity.
In five 24-week, double-blind, placebo-controlled, randomized studies (including the 3 studies above), the discontinuation rate due to adverse reactions was 13% among patients taking ADDYI vs. 6% among patients taking placebo. The adverse reactions most commonly causing discontinuation of ADDYI were dizziness (1.7%), nausea (1.2%), insomnia (1.1%), somnolence (1.1%), anxiety (1.0%) and fatigue (0.9%). Serious adverse reactions were reported in 0.8% of ADDYI-treated patients and 0.5% of placebo-treated patients.
Most common adverse reactions occurring in ADDYI clinical studies in postmenopausal women
| Placebo (n=849) | ADDYI (n=843) | |
|---|---|---|
| Dizziness | 3.3% | 8.4% |
| Somnolence | 1.8% | 7.9% |
| Nausea | 3.8% | 6.5% |
| Insomnia | 3.3% | 6.4% |
| Headache | 5.5% | 5.7% |
Adapted from the ADDYI product monograph.2
The majority of these adverse reactions emerged in the first 4 weeks of treatment and were of mild to moderate intensity.
In two double-blind, placebo-controlled, randomized studies, the discontinuation rate due to adverse events in patients treated with ADDYI (n=843) was 9.1% compared to 5.2% in placebo-treated patients (n=849). The adverse events most commonly causing discontinuation of ADDYI were insomnia (1.5%), and anxiety (1.2%). Serious adverse events were reported in 1.4% of ADDYI-treated patients and 0.8% of placebo-treated patients.
Dosing2
ADDYI comes in the form of a 100 mg pill. The recommended dose is 100 mg, taken orally, once daily at bedtime.
Bedtime dosing is important. ADDYI taken at a time other than bedtime can increase the risk of hypotension, syncope, and CNS depression (such as somnolence and sedation). If a dose of ADDYI is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day, and not to double the next dose.
Discontinue treatment after 8 weeks if the patient does not report an improvement in sexual desire and/or a reduction in associated distress.
Using ADDYI before or after moderate or strong CYP3A4 inhibitors:
- Start the moderate or strong CYP3A4 inhibitor 2 days after the last dose of ADDYI. When the benefit of initiating a moderate or strong CYP3A4 inhibitor within 2 days of stopping ADDYI clearly outweighs the risk of flibanserin exposure-related severe hypotension and syncope, carefully monitor the patient for signs of hypotension and syncope.
- Start ADDYI 2 weeks after the last dose of the CYP3A4 inhibitor.
Please see the Product Monograph for complete dosing and administration instructions.
Overdosing2
Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions. Acute overdosage has also been associated with seizure-like activity, hypertension, unresponsiveness to pain, mydriasis, slurred speech and fever.
Treatment should address the symptoms and supportive measures as needed. There is no known antidote specific for flibanserin.
*Start the conversation
ADDYI IS COVERED BY MANY CANADIAN INSURANCE PLANS. Patients should check their plan’s coverage, or speak with the plan administrator if they are having trouble with access.
Contact Us
Searchlight Medical Information
1-855-331-0830
info@searchlightpharma.ca
Contact Searchlight Medical Information to request more information about ADDYI or to report an adverse event.
Searchlight Pharma has a commitment to Health Canada to follow any pregnancies that occur during therapy with ADDYI through a registry. Should you become aware of such a pregnancy, please contact Searchlight Medical Information.
This site is intended for Canadian healthcare professionals only. ADDYI is a registered trademark of Searchlight Pharma Inc. or its affiliates. All other trademarks are the property of their respective owners. © Copyright 2021 Searchlight Pharma Inc.
Important Safety Information
Important Safety Information
Clinical use:
Special diagnostic considerations
- There is no normative age- or gender-related data on frequency or degree of sexual desire. Therefore, the diagnosis must rely on clinical judgment based on the individual’s characteristics, interpersonal determinants, life context and cultural settings.
- The clinician may need to assess both partners when discrepancies in sexual desire prompt the call for professional attention.
- When making the diagnosis, it is recommended to use the ADDYI Prescriber’s Checklist.
The safety and efficacy of ADDYI have not been established in patients >55 or <18 years of age.
Contraindications:
- Patients taking a moderate or strong CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, fluconazole, ritonavir, or clarithromycin)
- Patients with hepatic impairment
- Patients who are pregnant or breastfeeding
- Patients with resting systolic blood pressure <110 mmHg or diastolic blood pressure <60 mmHg and who are using alcohol
Most serious warnings and precautions:
Use of ADDYI and alcohol may increase the risk of severe hypotension and syncope. Patients taking ADDYI should use caution and limit alcohol consumption. The concomitant use of ADDYI with moderate or strong inhibitors of CYP3A4 or in patients with hepatic impairment causes a significant increase of flibanserin concentration which may be associated with severe hypotension and syncope.
Other relevant warnings and precautions:
- Hypotension and syncope
- Tachycardia and palpitations
- Increase monitoring for adverse reactions in patients who are CYP2C19 poor metabolizers
- Concomitant use of multiple weak CYP3A4 inhibitors
- Central nervous system depression
- Use in patients taking antidepressants
For more information:
Consult the Product Monograph at http://searchlightpharma.com/app/uploads/2020/09/Addyi-PM_EN.pdf for important information relating to adverse reactions, drug interactions, and dosing information which has not been discussed in this piece. The Product Monograph is also available by calling 1-855-881-0830.
References: 1. Goldstein I et al. Hypoactive Sexual Desire Disorder: International Society for the Study of Women’s Sexual Health (ISSWSH) Expert Consensus Panel Review. Mayo Clin Proc 2017;92(1):114-128. 2. ADDYI Product Monograph, Searchlight Pharma Inc. January 26, 2021. 3. Searchlight Pharma Inc. Data on File. March 3, 2021. 4. SOGC No.279-Female Sexual Health Consensus Clinical Guidelines. J Obstet Gynaecol Can 2018;40(6):e451 -e503 5. Clayton AH et al. Validity of the Decreased Sexual Desire Screener for Diagnosing Hypoactive Sexual Desire Disorder. J Sex Marital Ther 2013;39:132 -143 6. Katz M et al. Efficacy of Flibanserin in Women with Hypoactive Sexual Desire Disorder: Results from the BEGONIA Trial. J Sex Med 2013;10:1807-1815.
