THE PINK PILL – Review by April Neale

Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope.

The #1 Prescribed Treatment for frustrating Low Libido1

Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study. Neural basis of hypoactive sexual desire disorder in women: an event-related fmri study. Holstege G. How the emotional motor system controls the pelvic organs. Attitudinal survey of women living with low sexual desire.

Other Medical Problems

Continued efficacy and safety of flibanserin in premenopausal women with hypoactive sexual desire disorder (HSDD): Results from a randomized withdrawal trial. Jayne C, Simon JA, Taylor LV, Kimura T, Lesko LM; SUNFLOWER study investigators. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. Effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with hypoactive sexual desire disorder: A post hoc analysis. WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening. Severe hypotension and syncope can occur when ADDYI is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, ADDYI use in these settings is contraindicated.

INDICATION ADDYI (flibanserin) is indicated for the treatment of women less than 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: A co-existing medical or psychiatric condition, The effects of a medication or other drug substance.

See also:

We’re not there yet, but The Pink Pill provides a road map for how to successfully advocate for women’s health and sexual autonomy. Low sexual desire impacts 13 to 40 per cent — or between 536 million and 1.65 billion — of women globally. Despite these numbers and many negative effects — including relationship strain, shame, depression and body image issues — the film reveals an alarming gap in medical knowledge and training. Medical students are still not trained in women’s sexual health; not even at the top schools in the United States, as one physician in the documentary adds. The clitoris was excluded from instructional materials, another shares.

Keys to patient success

The medical and moral disdain surrounding female pleasure directly impacts how women with low libido are treated by their doctors, many of whom engage in medical gaslighting. The “oh, it’s just in your head” trope has haunted women for centuries, and doctors routinely advised patients with low sexual desire to take baths, plan date nights or submit to “duty sex.” As Eckert says, after disclosing her own struggles with HSDD: “We’re conditioned to not fight for it.” This was echoed in her first meeting with the U.S. Food and Drug Administration (FDA) to develop and market flibanserin in early 2010, when a male board member asked: “What do we need a bunch of horny women running around for?” Later that year, German pharmaceutical giant Boehringer Ingelheim released very promising results from a flibanserin clinical trial involving women affected by HSDD. However, in October 2010, the company halted the pursuit of FDA approval because, as Eckert said: “They didn’t want to take on women and sex.” That’s when she bought the rights to the drug and stepped up to be its champion. Eckert began by naming it Addyi after the Grey’s Anatomy character Addison Montgomery, who is widely admired for her staunch support of other women and for living life on her own terms.

Learn to recognize the signs of HSDD in your patients.4

After reviewing the brain scans of women with and without HSDD, Eckert discovered a scientific smoking gun. There were striking differences in the hypothalamus — the brain’s “sex centre” — between the samples, with the low-libido women exhibiting far less activity. This was evidence that low desire isn’t in women’s heads, it’s biological. Eckert’s team went ahead and launched the largest clinical trial in women’s health history for an FDA filing — involving more than 13,000 participants. However, as revealed in the documentary, despite the data clearly demonstrating Addyi’s positive impact on women’s sexual desire, in 2013 the FDA turned down the application to take the drug to market. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire.

Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner.

• Pink pills are sometimes associated with the "pink economy" in sexual health.
• They are popular among women seeking discreet, quick solutions.
• Not all pink pills are evidence-based; some rely heavily on marketing claims.
• Consulting a healthcare professional is essential before starting any supplement.

ADDYI is not indicated to enhance sexual performance. Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors Known hypersensitivity to ADDYI or any of its components.

• Pink pills are part of a broader trend towards female-centered wellness.
• They can potentially enhance intimacy, confidence, and overall satisfaction.
• Unregulated products pose risks of contamination or inappropriate ingredients.
• Always verify product credentials and manufacturer reputation before purchase.

Reactions, including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported. Hypotension and Syncope Due to an Interaction with Alcohol: See Boxed Warning for risks associated with alcohol consumption.

• The pink pill aims to boost women's libido and sexual satisfaction.
• It often contains ingredients like aphrodisiacs or hormonal components.
• Some pink pills are marketed as supplements; others are pharmaceutical drugs.
• Effectiveness varies; consult a healthcare provider before use.

After taking ADDYI at bedtime, advise patients to not use alcohol until the following day. Hypotension and Syncope with CYP3A4 Inhibitors: See Boxed Warning and Contraindication about use with moderate or strong cytochrome P450 3A4.

Episode Transcript

70% of women want you to start the convo about sexual health.2 70% of women want you to start the convo about sexual health.2 The exact mechanism of action of Addyi is unknown. I testified at the FDA 10 years ago when Addyi was approved — a watershed moment that validated women’s sexual health with the first FDA approved option to treat women with frustrating low libido. In my practice, it opened conversations that had long been silenced and gave patients hope. “Addyi has helped me get my libido back. My sweet husband has been so patient with me for years now – I dreaded his advances – I can’t tell you how wonderful it has been to want sex again.” “When I heard about Addyi, I was curious if it would work for me.

IN CLINICAL TRIALS1, WOMEN ON ADDYI EXPERIENCED:

After only a few weeks on Addyi I’m already thinking about and wanting sex again!” “I used to dread going to bed with my husband, because I was never in the mood… he thought it was his fault. IQVIA Monthly Total Prescriptions Volume Data in the US. MEDICAL pills for men INFO: 844-746-5745 x 3 medicalaffairs@sproutpharma.com MEDICAL INFO: 844-746-5745 x 3 medicalaffairs@sproutpharma.com IQVIA Monthly Total Prescriptions Volume Data Comparing Addyi vs Vyleesi in the US. Ryan KL, Arbuckle-Bernstein V, Smith G, Phillips J. Let’s Talk About Sex: A Survey of Patients’ Preferences When Addressing Sexual Health Concerns in a Family Medicine Residency Program Office.

What should I do if I miss a dose of Addyi?

Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. Sexual desire and the Female Sexual Function Index (FSFI): a sexual desire cutpoint for clinical interpretation of the FSFI in women with and without hypoactive sexual desire disorder. The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. Safety of flibanserin in women treated with antidepressants: A randomized, placebo-controlled study. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope.

What does this approval mean for other women’s health products?

Moderate success and dangerous side effects were cited, including the patronizing notion that “a woman might take Addyi the night before and fall asleep the next morning while driving her kids to school.” Undeterred, Eckert and her team spent over US$1 million conducting a driving study that revealed enhanced reaction times among women taking Addyi. Eckert also created the Even the Score campaign that brought Sprout’s mission of sexual health equity for women into public conversations in a new and powerful way. Influential physicians came on board for medical credibility, and so did women who’d taken Addyi. They protested, they supported Sprout and their local women’s health agencies, and they provided testimony when Eckert applied for FDA approval again. Their heartbreaking stories of divorce, self-doubt and soul-numbing frustration with being ignored or told their sexual lives are irrelevant are difficult to watch.

NEED TO KNOW

In August 2015, Sprout Pharmaceuticals won by a vote of 18-6. Two days later, Eckert sold Addyi to Valeant Pharmaceuticals for mass distribution for $1 billion. Valeant, however, then raised the price and imposed restrictions on the drug’s sale, placing it beyond the reach of most women financially, and many physicians refused to prescribe it. Spurred into action once again, Sprout Pharmaceuticals filed a lawsuit against Valeant. The case was dropped and Eckert bought Addyi back for $0 — a remarkable turnaround.

What should I tell my healthcare provider before using Addyi?

The Pink Pill is a galvanizing film that exposes how medical sexism contributes to the dismissal of women’s sexuality. Low desire, especially in midlife, is a real condition worthy of scientific research and pharmaceutical development. Using a documentary film as the medium to tell this story is, as producer Julie Bristow said in an interview, “a very powerful way of getting people to engage.” It’s an emotionally compelling film, but it’s also educational. This is a central goal for Bristow, who said: “What I hope women take away from this, and men, is that men and women’s sexual health is dealt with completely differently and in the wider health-care system as well.” By combining scientific debate, personal testimony and political activism, The Pink Pill makes a persuasive case that women’s sexual health has long been treated as a medical afterthought — that changing this truth requires cultural progress too. The only FDA-approved pill proven safe and effective for Hypoactive Sexual Desire Disorder (HSDD) in BOTH premenopausal and postmenopausal women (<65).