Ronnie Fass, MD: On-Demand Vonoprazan for Non-Erosive GERD “Within Our Reach”

Vonoprazan (Voquezna) recently earned US Food and Drug Administration approval for the daily treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD), but new research suggests the oral small molecule potassium-competitive acid blocker (PCAB) may be an effective on-demand treatment.

The most common phenotype of GERD, non-erosive GERD (NERD) often presents with episodic symptoms, one of the most frequent being heartburn. Due to many patients’ lack of consistent symptoms, non-continuous NERD treatment may offer a more appealing care option for patients seeking to take control of their treatment and take medication only as needed.

“Most of the patients with non-erosive reflux disease, the vast majority, have episodic symptoms. On-demand, which is part of the noncontinuous treatment for GERD, appears to be within our reach, with the availability of vonoprazan and potentially other PCABs coming to the market,” Ronnie Fass, MD, division director of gastroenterology and hepatology and medical director of the Digestive Health Center at MetroHealth, explained to HCPLive. “That might be more appealing to patients and physicians alike because patients like to take control of their treatment, and that will allow them to take the medication whenever they need it.”

Currently, vonoprazan is indicated as a daily treatment for NERD, but findings from a post hoc analysis of a double-blind, randomized, placebo-controlled phase 2 trial presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, suggest the drug’s efficacy as an on-demand treatment in patients who respond to continuous treatment.

Patients who completed a run-in period of daily vonoprazan 20 mg for 4 weeks were randomly assigned to receive vonoprazan 10 mg, 20 mg, 40 mg, or placebo and prompted to take the study drug when experiencing heartburn. Heartburn severity was reported at the time of treatment and after taking the study drug, with improvement in severity defined as ≥ 1 grade reduction from the initial severity.

Patients eligible for the on-demand period (n = 207) reported a mean 16.1% (95% CI: 13.5%-18.7%) heartburn-free days during screening, which increased during the run-in period to a mean of 82.9% (95% CI: 80.4%-85.4%). When transitioning to on-demand treatment, investigators noted the percentage of heartburn-free days remained above pre-treatment levels for all treatments, ranging from 71% to 75%, and were consistent through the 6-week treatment period.

“I just hope that the phase 3 trial will be able to replicate the phase 2 results because I think having noncontinuous treatment as an option in gastroesophageal reflux disease would be a great advantage,” Fass concluded.

Editors’ note: Fass has relevant disclosures with Medtronic, Phathom Pharmaceuticals, Takeda, and others.

References

1. ^{Brooks, A. Vonoprazan (Voquezna) Receives FDA Approval for Heartburn Associated with Non-Erosive GERD. HCPLive. July 18, 2024. Accessed October 28, 2024. https://www.hcplive.com/view/vonoprazan-receives-fda-approval-for-heartburn-associated-with-non-erosive-gerd}
2. ^{Fass R, Chen JW, Heidelbaugh JJ, et al. 4 - Heartburn Frequency and Symptom Improvement Rates of Treated Episodes when Switching From Daily to On-Demand Vonoprazan Treatment for Non-Erosive Reflux Disease. Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}