About the Author
Jean Cunningham, PharmD, BCPS, is Senior Director of Medical Affairs at Empower Pharmacy. The opinions expressed are those of the author and do not necessarily represent the views of Empower Pharmacy.
As options expand, pharmacists play an increasingly important role in working collaboratively with prescribers and patients to deliver individualized, evidence-based care.
More than 1 million women in the United States enter menopause each year, making menopause management an increasingly important aspect of clinical practice.¹ Although menopausal hormone therapy (MHT) remains the most effective treatment for vasomotor symptoms (VMS), the therapeutic landscape has changed considerably over the past several years. Novel nonhormonal therapies, expanded treatment options for genitourinary syndrome of menopause (GSM), increasing recognition of female sexual dysfunction, and growing emphasis on metabolic health have shifted menopause care toward a more individualized approach.
Pharmacists are well positioned to help prescribers and patients navigate these evolving therapies, evaluate emerging evidence, and distinguish established treatments from investigational interventions increasingly promoted through longevity and wellness clinics. The Table outlines emerging therapies.
Despite decades of controversy following the Women's Health Initiative, contemporary guidance emphasizes that MHT remains the gold standard for treating moderate to severe VMS in appropriately selected patients.² Current recommendations support initiating therapy in women younger than 60 years or within 10 years of menopause onset, when the overall benefit-risk profile is most favorable.²
Clinical practice has also evolved toward lower effective estrogen doses and greater use of transdermal estradiol, particularly in women with cardiovascular risk factors or concerns regarding venous thromboembolism. Micronized progesterone has become a preferred progestogen for many women requiring endometrial protection because of its favorable metabolic and cardiovascular profile.²
Rather than asking whether hormone therapy is appropriate for all women, clinicians now focus on identifying which patients are most likely to benefit through individualized risk assessment and shared decision-making.
The most significant therapeutic advance in menopause management is the introduction of neurokinin receptor antagonists. Fezolinetant (Veozah; Astellas Pharma US, Inc) became the first FDA-approved NK3 receptor antagonist for moderate to severe VMS.³ Unlike estrogen therapy, fezolinetant targets hypothalamic kisspeptin/neurokinin B/dynorphin neurons involved in thermoregulation, providing symptom relief without hormonal exposure. Phase 3 SKYLIGHT trials (NCT04003155, NCT04003142, NCT04003142, NCT04003389) demonstrated clinically meaningful reductions in hot flash frequency and severity within weeks of treatment.⁴˒⁵
The emergence of this new therapeutic class offers an important alternative for women with contraindications to estrogen, including some breast cancer survivors or patients who prefer nonhormonal therapy. Pharmacists should also be familiar with recommended hepatic monitoring following FDA safety updates regarding rare cases of drug-induced liver injury.⁶
Elinzanetant (Lynkuet; Bayer HealthCare Pharmaceuticals, Inc), a dual NK1/NK3 receptor antagonist, recently became the second FDA-approved nonhormonal therapy for moderate to severe VMS associated with menopause.⁷ In phase 3 OASIS trials (NCT05042362, NCT05099159, NCT05030584, NCT05587296), elinzanetant significantly reduced the frequency and severity of VMS while also improving sleep and mood outcomes.⁸
Modern menopause care extends beyond hot flashes. GSM affects approximately half of postmenopausal women and often remains undertreated.⁹ Low-dose vaginal estrogen continues to be considered first-line therapy for vulvovaginal symptoms because systemic absorption is minimal while symptom improvement is substantial.²
Alternative therapies include intravaginal dehydroepiandrosterone with prasterone (Intrarosa; Endoceutics) and the oral selective estrogen receptor modulator ospemifene (Osphena; Duchesnay USA), both approved for dyspareunia associated with vulvovaginal atrophy.⁹
Recognition of hypoactive sexual desire disorder (HSDD) has also increased. International guidelines support testosterone therapy for carefully selected postmenopausal women diagnosed with HSDD, although no testosterone product is currently FDA approved specifically for women in the United States.¹⁰ This therapeutic gap has contributed to continued reliance on individualized treatment approaches, including compounded preparations when commercially available products cannot adequately meet patient needs.
Many women experience increased visceral adiposity, insulin resistance, and adverse changes in body composition during the menopausal transition. Although glucagon-like peptide-1 receptor agonists are not menopause therapies, they have become increasingly relevant in the management of obesity and cardiometabolic disease among midlife women.¹¹
Weight reduction achieved through semaglutide (Wegovy; Novo Nordisk) and tirzepatide (Zepbound; Eli Lilly) may indirectly improve mobility, quality of life, and cardiovascular risk, complementing traditional menopause management strategies. Pharmacists should recognize that these medications address metabolic consequences associated with menopause rather than estrogen deficiency itself.
Interest in peptide-based therapies has expanded rapidly through longevity clinics and social media, often outpacing available clinical evidence.
Growth hormone secretagogues such as CJC-1295 and ipamorelin are promoted for improving body composition, energy, and muscle mass despite limited clinical evidence supporting their use in menopausal women.¹² Likewise, peptides including BPC-157 and thymosin derivatives have gained popularity for tissue repair and recovery but currently lack robust human data or endorsement from major menopause guidelines.
Bremelanotide (Vyleesi; Cosette Pharmaceuticals), a melanocortin receptor agonist approved for premenopausal women with acquired generalized HSDD, has generated interest for off-label use after menopause. However, evidence in postmenopausal women remains limited.¹³˒¹⁴
Compounding pharmacists continue to play an important role in individualized menopause care despite the availability of numerous FDA-approved hormone therapies. Compounded preparations may be appropriate for patients requiring customized strengths, unique dosage forms, allergen-free formulations, or testosterone therapy when no commercially available product meets clinical needs. However, compounded bioidentical hormone therapy should not be viewed as inherently safer or more effective than FDA-approved products.²
Jean Cunningham, PharmD, BCPS, is Senior Director of Medical Affairs at Empower Pharmacy. The opinions expressed are those of the author and do not necessarily represent the views of Empower Pharmacy.
Pharmacists are uniquely positioned to educate prescribers and patients regarding the differences between FDA-approved and compounded therapies, ensure appropriate quality standards, identify potential medication interactions, and reinforce realistic expectations regarding emerging treatments that have not yet demonstrated clinical benefit.
Menopause management has entered an era of precision medicine in which treatment decisions extend well beyond traditional hormone replacement. New nonhormonal therapies, individualized hormone strategies, expanded attention to sexual and metabolic health, and continued innovation in women's health are transforming clinical practice.
As trusted members of the health care community, pharmacists will remain central to helping patients navigate an increasingly complex therapeutic landscape while ensuring that clinical decisions are guided by evidence rather than enthusiasm.