FDA Accepts New Drug Application for Elinzanetant to Treat Hot Flashes Associated With Menopause

The FDA accepted a new drug application (NDA) for elinzanetant (Bayer), an investigational compound for the treatment of moderate-to-severe vasomotor symptoms (VMS), commonly known as hot flashes which are relate to menopause.¹

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“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the US,” Christine Roth, executive vice president of global product strategy and commercialization and member of the pharmaceutical leadership team at Bayer, said in a news release.¹

Menopause is described as a transitional period in the women’s life with the decline of ovarian function, occurring in women during their 40s or early 50s. Study authors noted that the decline in hormones relates to symptoms that can disturb a woman’s health, quality of life, health care utilization, and work production. Other than VMS, women undergoing menopause can experience sleep disturbances and mood changes.¹

VMS is a result of hyperactivation of the thermoregulatory pathway, which is mediated by hypertrophy of the KNDy neurons, according to the release. Up to 80% of women experience VMS throughout the menopausal transition and are one of the main causes for seeking medical care during this phase. Out of the 80% of women, one-third report severe symptoms from VMS, which can last for more than 10 years after the last menstrual cycle.¹ However, while is it difficult for everyone, hot flashes could occur before or during menopause before exceeding for a few years. Finding solutions to cope with VMS could lessen symptoms like avoiding things that could trigger them, including heat, alcohol, or spicy foods— emphasizing the need for further treatments.²

As the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, elinzanetant could provide benefit for women suffering from VMS. The drug is currently in late-stage clinical trial development to provide non-hormonal treatment for moderate to severe VMS that relates to menopause. The role of elinzanetant is to modulate a group of estrogen sensitive neurons in the hypothalamus area of the brain that disrupt body heat control mechanisms.¹

The NDA was granted based on positive results from the OASIS 1 (NCT05042362), 2 (NCT05099159), and 3 (NCT05030584) phase 3 studies that assessed the efficacy and safety of elinzanetant compared to a placebo. The study authors noted that OASIS 1 and 2 evaluated elinzanetant administered orally once daily in women with severe VMS associated menopause over 26 weeks among women between 40 and 65 years of age. OASIS 3 investigated elinzanetant for VMS over 52 weeks in postmenopausal women between 40 and 65 years of age. Lastly, the OASIS 4 study expanded the clinical phase 3 program and investigated the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy to treat breast cancer.¹

Bayer is currently conducting an exploratory phase 2 randomized, parallel-group treatment, double-blind NIRVANA (NCT06112756) study to assess the efficacy of elinzanetant on aiding sleep disturbances connected with menopause.¹

“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency,” said Roth in a news release.¹

REFERERNCES

1. U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant. Business Wire. October 9, 2024. Accessed October 10, 2024. https://www.businesswire.com/news/home/20241009445867/en/U.S.-Food-and-Drug-Administration-FDA-accepts-New-Drug-Application-for-elinzanetant

2. Hot Flashes. Cleveland Clinic. News release. March 21, 2022. Accessed October 11, 2024. https://my.clevelandclinic.org/health/articles/15223-hot-flashes