Phathom Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Voquezna (vonoprazan) 10mg tablets to relieve heartburn related to non-erosive gastroesophageal reflux disease (non-erosive GERD) in adults.

Voquezna is an oral small-molecule potassium-competitive acid blocker (PCAB), a novel class of medicines that inhibit stomach acid secretion.

Phathom licensed the US rights to Voquezna from Japanese drugmaker Takeda, which markets the product in Japan and other countries in Asia and Latin America.

Voquezna is already approved in the US, for treating all severities of erosive esophagitis (EE), known as Erosive GERD, in adults.

In addition, the drug is also approved for use with antibiotics amoxicillin or amoxicillin and clarithromycin, to treat Helicobacter pylori (H. pylori) infection.

Phathom Pharmaceuticals president and CEO Terrie Curran said: “For decades GERD sufferers had no new class of treatment to turn to in the US.

“This approval provides patients and healthcare providers with immediate access to the first and only FDA-approved treatment of its kind, from a new class of acid suppression therapy, and the power to help provide complete 24-hour heartburn-free days and nights.”

The FDA approval of Voquezna in non-erosive GERD is supported by the positive results from the PHALCON-NERD-301 study.

The Phase 3 randomised, placebo-controlled, double-blind, multi-site US trial evaluated Voquezna’s efficacy and safety for daily treatment in adults with non-erosive GERD.

It enrolled more than 770 adult patients with non-erosive GERD who experienced heartburn four or more days per week, with most having heartburn six to seven days.

The study compared the relief of heartburn over four weeks between patients treated with Voquezna 10mg and those given a placebo.

In addition, a 20-week extension period was conducted where all participants received Voquezna to assess long-term treatment.

The study results showed that Voquezna substantially reduced the heartburn with daily treatment through the fourth week.

In addition, the drug achieved more complete all-day and all-night heartburn-free days, and significantly more 24-hour heartburn-free days than placebo, the primary endpoint.

The most common adverse reactions reported in the study include abdominal pain, constipation, diarrhoea, nausea, and urinary tract infections.