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VMS and Menopause

Atopic Dermatitis Provider Toolkit

Adult Immunization Provider Toolkit

Dermatology Hot Topics

1rem

Authors

Internal medicine doctors train predominantly in our high-tech academic medical centers, yet most will provide outpatient care. Here, Dr Andrew Morris-Singer frames one of modern health care’s greatest disconnects.

Medical Training for the 1%

A 9-year-old boy presented with a 1-week history of pruritus and rash on his elbows, knees, back, and legs. Several areas of excoriation were noted. He had recently run through a field of tall grass but denied any other exposure history.

A 9-year-old boy presented with a 1-week history of pruritus and rash on his elbows, knees, back, and legs. He had recently run through a field of tall grass but denied any other exposure history. Your Dx?

Clinical Topics

What Cause of This Itchy Rash?

A 5-year-old boy with a history of atopic dermatitis since 6 weeks of age, presents with a rash around his mouth that has been present for approximately 1 year. The patient’s mother reports that desonide topical cream was applied to the affected area for about 5 days, which initially resulted in improvement, however the rash returned after this medication was discontinued. The rash also recently improved after the patient took amoxicillin for an infection. She also notes that the patient has been licking his lips more frequently.

On examination there is an erythematous papulopustular eruption restricted to the perioral region, with sparing of the vermillion border. Mild hyperpigmentation is noted on the patient’s neck. There is no active involvement of other areas of the body.

The eruption has been present for 1 year and is restricted to the perioral region. What is included in your differential? 

Rash Around the Mouth of a 5-year-old Child


These 2 patients presented with a swollen hand and rapidly proximally progressive edema secondary to a bite.

These 2 patients presented with a swollen hand and rapidly proximally progressive edema secondary to a bite. What creature did the biting?

Swollen Hands-What’s Biting?

A 66-year-old woman had a mildly pruritic rash on the buttocks, lower back, abdomen, and upper posterior thighs. The eruption had been present for approximately 18 months.

A 66-year-old woman had a mildly pruritic rash on the buttocks, lower back, abdomen, and upper posterior thighs. The eruption had been present for approximately 18 months. Your diagnosis?

“Swimsuit Area” Rash: Your Dx?

A 67-year-old woman noted the appearance of several non-tender, rock-hard, purple-colored nodules on her legs. Her medical history was significant for distant non-Hodgkin lymphoma.

A 67-year-old woman noted the appearance of several non-tender, rock-hard, purple-colored nodules on her legs. Her medical history was significant for distant non-Hodgkin lymphoma. The violaceous color and configuration of the skin lesions suggests which of the following? 

Hard Purple Nodules: Your Dx?

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first global marketing authorization for elinzanetant, a dual neurokinin-1 and neurokinin-3 receptor antagonist, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with 

The drug will be marketed under the brand name Lynkuet™ in the UK. The US FDA set a Prescription Drug User Fee Act date for July 26, 2026, after accepting Bayer's New Drug Application in October 2024.

Elinzanetant is the first dual-action, nonhormonal therapy in its class to receive regulatory approval for menopausal VMS, which affects up to 80% of women during the menopausal transition. Despite the high prevalence, nearly two-thirds of symptomatic women remain untreated, according to Bayer.

The UK approval is based on results from Bayer’s Phase III OASIS clinical development program, comprising 3 pivotal studies (OASIS-1, -2, and -3). Across all 3 trials, elinzanetant met primary efficacy endpoints and showed a favorable safety profile.

Elinzanetant significantly reduced the mean frequency and severity of moderate to severe VMS at weeks 4 and 12 compared with placebo.

At week 26, more than 80% of participants in the elinzanetant arm achieved at least a

, including those who switched from placebo after week 12.

The treatment also led to statistically significant improvements in sleep disturbance and menopause-related quality of life.

Secondary endpoints were met, including a reduction in VMS frequency as early as week 1.

Elinzanetant demonstrated a statistically significant reduction in moderate to severe VMS frequency by week 12, sustained over 52 weeks.

The most commonly reported adverse events were headache, fatigue, and somnolence.

“I welcome expanded therapeutic options that address the diverse needs and preferences of women going through menopause," Paula Briggs, MBChB, a consultant gynecologist in sexual and reproductive health in Liverpool Women’s NHS Foundation Trust and immediate past chair of the British Menopause Society, said in a press release. "Physicians now have a new hormone-free treatment option that offers an alternative for tailoring treatment plans, helping women manage their symptoms and potentially enhance their overall quality of life during this important transition.”

Bayer reported that regulatory submissions for elinzanetant are underway in the US, European Union, and additional markets.

Bayer receives first approval worldwide for Lynkuet™ (elinzanetant) in the UK as treatment of moderate to severe vasomotor symptoms associated with menopause. News release. Bayer. July 10, 2025. Accessed July 11, 2025. 

https://www.bayer.com/media/en-us/bayer-receives-first-approval-worldwide-for-lynkuet-elinzanetant-in-the-uk-as-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/

Halsey G. Elinzanetant Update: FDA Accepts Bayer NDA, Sets July 2025 PDUFA Date. 

https://www.patientcareonline.com/view/elinzanetant-update-fda-accepts-bayer-nda-sets-july-2025-pdufa-date

Halsey G. Elinzanetant meets safety, efficacy endpoints in phase 3 studies of menopausal VMS. 

https://www.patientcareonline.com/view/elinzanetant-meets-safety-efficacy-endpoints-in-phase-3-studies-of-menopausal-vms

Jennings S. Topline phase 3 data released for elinzanetant efficacy for moderate-to-severe VMS. 

https://www.patientcareonline.com/view/topline-phase-3-data-released-for-elinzanetant-efficacy-for-moderate-to-severe-vms

Bayer's elinzanetant gains UK approval as the first dual-action, nonhormonal treatment for menopausal symptoms.

Elinzanetant Gets UK Nod for Moderate to Severe Vasomotor Symptoms in Menopause: Is the US Far Behind?

Andrew Morris-singer, MD

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