Innovations in GERD: What Vonoprazan (Voquezna) May Offer Over PPIs, with Adelina Hung, MD

Proton pump inhibitors have long been the mainstay of treatment for gastroesophageal reflux disease (GERD), dating back to omeprazole (Prilosec)’s initial approval in 1989. However, the treatment landscape has undergone its first major changes in the past 30 years with the emergence of vonoprazan (Voquezna).^1,2

A novel, first-in-class small molecule potassium-competitive acid blocker (PCAB), vonoprazan now boasts 3 US Food and Drug Administration (FDA) approvals across both erosive and non-erosive GERD. Less than a year after earning approval for the healing and maintenance of healing of all grades of erosive GERD as well as the relief of heartburn associated with erosive GERD, vonoprazan has also been approved for the treatment of heartburn in non-erosive GERD.²

“Millions of patients with Non-Erosive GERD continue to suffer from heartburn despite current treatment options,” Colin Howden, MD, professor emeritus at the University of Tennessee College of Medicine, said in a press release.³ “The pivotal study that led to this approval showed that VOQUEZNA significantly reduced heartburn episodes in patients with Non-Erosive GERD along with an established safety profile. Today’s approval of VOQUEZNA provides physicians with a novel, first-in-class treatment that can quickly and significantly reduce heartburn for many adult patients.”

The decision was based on data from the phase 3 PHALCON-NERD-301 study evaluating the efficacy and safety of vonoprazan as a daily treatment in adult patients with non-erosive GERD, with results showing a significantly greater percentage of 24-hour heartburn-free days in patients treated with vonoprazan versus placebo (46.4% with vonoprazan 10 mg and 46.0% with vonoprazan 20 mg vs 27.5% with placebo; P <.0001). Additionally, the median percentage of 24-hour heartburn-free days was greater with vonoprazan 10 mg (48.3%) and 20 mg (46.7%) compared with placebo (17.0%).²

“The thing with PPIs is that they have some shortcomings that [potassium competitive acid blockers] typically don't have,” Adelina Hung, MD, clinical assistant professor at Rosalind Franklin University Chicago Medical School and director of the IBD program at Sinai Health System Chicago, explained to HCPLive in an episode of HCPLive Podcasts. “This new type of medication kind of helps of all of these other shortcomings that we have with PPIs and provides another option for patients.”

Specifically, she highlighted vonoprazan’s onset of action as a notable benefit versus PPIs, describing how she usually has to tell her patients it may take a couple of weeks before they see the full treatment effect with PPIs, which may lead them to stop taking the medication.

“I think having something that works fast would help with adherence and might be better for our patients overall,” she said.

References

1. ^{Strand DS, Kim D, Peura DA. 25 Years of Proton Pump Inhibitors: A Comprehensive Review. Gut Liver. 2017;11(1):27-37. doi:10.5009/gnl15502}
2. ^{Brooks, A. Vonoprazan (Voquezna) Receives FDA Approval for Heartburn Associated with Non-Erosive GERD. HCPLive. July 18, 2024. Accessed July 18, 2024. https://www.hcplive.com/view/vonoprazan-receives-fda-approval-for-heartburn-associated-with-non-erosive-gerd}
3. ^{Phathom Pharmaceuticals, Inc. Phathom Pharmaceuticals announces FDA approval of VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with non-erosive GERD in adults. Phathom Pharmaceuticals, Inc. Accessed July 18, 2024. https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-announces-fda-approval-voqueznar-0}