BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date. During a presentation on April 18 at the annual American College of Physicians Internal Medicine Meeting, Gerald Smetana, MD, professor of medicine in the Division of General Medicine at Beth Israel Deaconess Medical Center in Boston, reviewed four of these new therapies that are likely to be particularly important for primary care clinicians.
A New First-Line for GERD?
Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD).
GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.
“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Smetana told attendees.
Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.
Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Smetana said.
Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
Nonhormonal Drug for Menopause
Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.
“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Smetana said.
Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia.
Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.
“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
RSV Vaccine for Everyone
Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention.
The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.
Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.
Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.
“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Smetana said.
As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
New Antidepressants
A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.
Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression.
Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.
“So why is this medication worth discussing now?” Smetana said. “It’s because the side effect profile is different from existing antidepressants.”
Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said.
Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Smetana said.
Gepirone will be available to prescribe to patients in fall 2024.
Smetana reported no relevant financial conflicts of interest.
Lara Salahi is a journalist living in Boston.
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