JoAnn Pinkerton discusses elinzanetant's crucial role in VMS therapy

In a recent interview with Contemporary OBGYN, JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia, discussed the FDA's acceptance of a New Drug Application (NDA) for elinzanetant, an investigational drug for menopausal vasomotor symptoms such as hot flashes and night sweats.

Pinkerton highlighted that FDA acceptance of the NDA is a significant step toward improving menopausal care in the United States. If approved, elinzanetant would be the third FDA-approved non-hormonal option for treating moderate-to-severe vasomotor symptoms (VMS), addressing unmet needs in efficacy, safety, and accessibility. Many women face challenges with current treatments, making it crucial to have more options.

In the OASIS 1 and 2 trials, elinzanetant significantly reduced the frequency and severity of vasomotor symptoms over 12 weeks, with sustained results at 26 weeks. Notably, the drug had rapid effects, with symptom reduction visible as early as 1 week. By week 26, over 80% of participants saw a 50% reduction in symptom frequency. Improvements in sleep disturbances and quality of life were also observed. These findings were confirmed in OASIS 3, a 52-week trial,where participants continued to show reduced symptoms and better sleep.

Pinkerton emphasized the need for non-hormonal therapies, especially since not all women want or can take hormone therapy. VMS, which impact up to 80% of menopausal women, are not only disruptive but also linked to various health issues, including cardiovascular and cognitive changes, bone loss, and mood disturbances. Elinzanetant, a dual neurokinin receptor antagonist, has a different mechanism than current treatments, showing promising results in clinical trials with a favorable safety profile.

The next steps include ongoing monitoring of side effects, which have so far included fatigue, headaches, and joint pain but no endometrial or liver issues. Elinzanetant is also being tested in women with breast cancer on tamoxifen or aromatase inhibitors, and those with significant sleep disturbances.