4 New Drugs for Menopause, Depression, GERD and RSV You Need to Know

The US Food and Drug Administration (FDA) has been very busy in recent years, approving 55 new drugs in 2023 and another 11 in 2024. These developments were discussed in a presentation by Dr. Gerald Smetana, professor of medicine at Beth Israel Deaconess Medical Center in Boston, during the annual meeting of the American College of Internal Medicine.

A new drug for gastroesophageal reflux disease

One of the notable new therapies is Vonoprazan, a competitive oral potassium acid blocker approved in November 2023. Designed to treat gastroesophageal reflux disease (GERD), it offers an alternative for patients who do not find relief with standard medications such as proton pump inhibitors (PPIs).

The efficacy of Vonoprazan was demonstrated in the phase 3 PHALCON-EE study, where it outperformed lansoprazole in the treatment of erosive esophagitis. However, its six-month FDA approval and higher cost compared to H2 blockers could limit its affordability for patients.

Non-hormonal drug for menopause

Another breakthrough approval is Fezolinetant, the first neurokinin receptor antagonist approved by the FDA to address vasomotor symptoms associated with menopause. Fezolinetant targets the brain regions responsible for regulating body temperature and sweating, providing a non-hormonal alternative to hormone-based therapies. The SKYLIGHT 1 study demonstrated its effectiveness in reducing the frequency and severity of hot flashes, although it comes with side effects such as abdominal pain and insomnia.

Photo: Freepik @Drazen Zigic

Respiratory syncytial virus vaccines

Respiratory syncytial virus (RSV) is no longer just a concern for young children, but is increasingly affecting older adults. Recognizing this, the FDA has approved two RSV vaccines specifically for this demographic. Despite a significant 83% reduction in the relative risk of RSV infection seen in vaccinated individuals, vaccinating older patients remains a challenge, according to Medscape.

Moderna is also developing an mRNA vaccine for RSV similar to many COVID-19 vaccines, preliminary studies have shown no neuroinflammatory disorders among recipients.

Antidepressant drugs

Finally, the long-awaited approval of Gepirone marks a new direction in the treatment of major depressive disorder. Despite being rejected by the FDA several times due to concerns about study size and efficacy, Gepirone was finally approved in September 2023. It offers a different mechanism of action compared to SSRIs, the current treatment of first line for depression.

Gepirone’s unique side effect profile, which may reduce the likelihood of sexual dysfunction in men compared to SSRIs, makes it a promising addition to antidepressant therapies.

In short, these newly approved drugs signal significant advances in various medical fields. From new options for treating GERD and relieving menopausal symptoms to addressing the growing concern of RSV in older adults and offering an alternative treatment for depression, these drugs offer hope for better outcomes for patients.

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