Voquezna (Vonoprazan) is a new and unique medicine that the FDA has approved for treating both erosive and non-erosive GERD (gastroesophageal reflux disease).
GERD is a common condition usually treated with antacids and PPIs (like Omeprazole and Lansoprazole). However, over time, people can develop a tolerance to these medications.
When PPIs are used for a long time, the body tries to produce more proton pumps to increase acid production, which leads to drug tolerance. This means people often need higher doses of PPIs.
Using a different type of medicine, like Voquezna, can help overcome this tolerance by giving the body a break from PPIs.
Voquezna works on different receptors, making it a good option for patients who don’t respond well to PPIs.
The approval of Voquezna (Vonoprazan) highlights the progress in research for treating stomach and digestive problems. This new medicine could be the first of many new treatments for GERD and similar conditions.
Understanding Non-Erosive GERD
We must understand the basics of GERD before we talk more about this ground-breaking news.
GERD, or gastroesophageal reflux disease, is a common digestive disorder in which stomach acid flows back into the esophagus which feels as terrible as it sounds.
When we say ‘erosive’ GERD, it refers to damage caused to the esophageal lining as acid splashes into it. Non-erosive GERD is similar in symptoms to Erosive GERD, however, the stomach and esophageal linings are not damaged.
Even though there is no visible damage to the esophagus, Non-Erosive GERD can significantly alter a person’s quality of life.
Until recently, treatment options for Non-Erosive GERD were limited, and many individuals have found relief through over-the-counter medications or lifestyle changes.
How does Voquezna work?
Voquezna (Vonoprazan) is a potassium-competitive acid blocker (P-CAB) [ref].
Unlike typical proton pump inhibitors (PPIs) that stop the enzyme that makes stomach acid, these drugs compete with potassium on the enzyme (H+/K+ ATPase) in the stomach cells that produce acid. This way, Voquezna stops acid production right at the source.
The action of Voquezna is reversible and does not require acid for its activation. Thus, it works faster than PPIs and provides a quick relief from heartburn than PPIs.
This new way of working has multiple benefits over PPIs, as P-CABs are better at reducing stomach acid, and they can lower acid levels more than PPIs.
Lastly, P-CABs offer longer-lasting relief, helping with heartburn throughout the day and night [ref].
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Clinical Trials and Efficacy
The FDA approval of Voquezna was based on a clinical trial program that tested its efficacy and safety in patients with Non-Erosive GERD.
The hallmark of this program was the Phase 3 PHALCON-NERD-301 trial, which is a large-scale, multicenter, double-blind, placebo-controlled study.
In this trial, subjects with Non-Erosive GERD were randomly assigned to receive either Voquezna or a placebo once daily for eight weeks.
The first result of the study was the change from baseline in the frequency of heartburn episodes per week, which showed a positive response to Voquezna.
Patients taking Voquezna experienced a better reduction in heartburn episodes compared to those on placebo.
Moreover, this drug showed improvements in secondary endpoints, such as the severity of heartburn episodes, the number of heartburn-free days, and overall patient satisfaction with treatment.
Further supporting the evidence for Voquezna’s efficacy were two additional Phase 3 trials, PHALCON-NERD-302 and PHALCON-NERD-303.
These studies used similar designs and found consistent findings which is proof that Voquezna was superior to placebo in reducing heartburn frequency and improving overall NERD symptoms.
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Key Benefits of Voquezna (Vonoprazone)
Rapid onset of action:
The effects of these drugs against heartburn can be felt within an hour. This means that patients can experience improvement in their symptoms soon after taking the medication.
Long-lasting effect:
The maintained acid-suppressing action of Voquezna gives you long-lasting relief from heartburn.
Unlike some other meds, the effects of Voquezna do not wear off as quickly, so you won’t need multiple doses. This can improve your sleep quality and overall well-being.
Improved heartburn-free days:
Clinical trials have shown that Voquezna significantly increases the number of days patients experience no heartburn symptoms [ref].
So, you would not be stressing over this condition every time you got out with your friends.
Enhanced quality of life:
As the fear of heartburn is gone, this med will help with sleeping better and lowering stress and lets you eat more types of food without pain.
So, there are no more concerns about your social life and you can continue your daily activities without a stinging pain in your chest.
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Key Considerations:
Like PPIs, Voquezna use is associated with a deficiency of vitamin B12 and magnesium. People on long-term PPIs or Voquezna need to supplement their diets with these supplements.
In addition, acid suppression using Voquezna, like PPIs, may lead to frequent gastrointestinal infections such as clostridium difficile induced diarrhea (CDAD).
Hope for millions
The approval of Voquezna brings renewed hope to millions suffering from non-erosive reflux disease (NERD).
This new treatment provides an effective solution for a condition that has been previously difficult to manage.
Even though lifestyle modifications and over-the-counter medications are a good thing for managing heartburn, still Voquezna stands out as a valuable addition.
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Conclusion
While Voquezna is a promising treatment, it is important to talk to a healthcare professional to see if it is right for you.
Everyone’s needs and health conditions are different, so a personalized plan for managing heartburn is key.
As more research is being conducted, we can look forward to even better treatments for GERD and similar issues.