Important step forward for Phathom Pharmaceuticals as FDA accepts NDA for new daily heartburn drug

11 Dec 2023
www.outsourcing-pharma.com
Phase 3NDADrug Approval
The company that focuses on remedies for gastrointestinal diseases announced on December 7 that the US Food and Drug Administration (FDA) has accepted for review its new drug application (NDA) for small molecule Voquenza as a daily treatment for adults.
The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.
"Today marks an important step forward for Phathom Pharmaceuticals as we announce the FDA's acceptance for filing of our New Drug Application for Voquenza as a daily treatment of heartburn for patients with Non-Erosive GERD,” said Azmi Nabulsi, chief operating officer at Phathom.
Non-erosive GERD treatment
“Non-Erosive GERD represents a substantial segment of the US GERD population, affecting millions of individuals and impacting their quality of life. The supportive data in our regulatory application include the positive phase 3 results from the investigational PHALCON-NERD-301 trial, along with a safety profile consistent with prior studies.
“We look forward to working closely with the FDA throughout the review process and if approved, expect to launch Voquenza for this new indication in the third quarter of 2024.”
Non-Erosive GERD is the largest subcategory of GERD and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. Phathom says there are an estimated 38 million US adults living with Non-Erosive GERD, of these approximately 15 million are diagnosed and treated with a prescription medicine annually.
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Episodic heartburn
The company says symptoms impact the overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain.
Heartburn causes a burning feeling in the chest that is caused by stomach acid traveling up towards the throat – acid reflux. If this becomes regular it can be referred to as GERD. Other symptoms can include a unpleasant sour taste in the mouth, a cough or hiccups that keep returning, a hoarse voice, bad breath or bloating or feeling sick. The symptoms can often worsen when lying down or bending over.
Research shows that although lots of people get heartburn from time to time, there are no obvious reasons why although some medicines such as anti-inflammatory painkillers, like ibuprofen, a hiatus hernia (when part of the stomach moves up into the chest, a stomach ulcer or bacterial infection in the stomach can be causes.
Phase 3 study
Phathom is also finalizing its plans to initiate an additional phase 3 study in 2024 evaluating Voquenza as an investigational as-needed treatment for episodic heartburn relief in adults with non-erosive GERD, a novel dosing treatment regimen for which proton pump inhibitors (PPIs) are not approved in the US.
Voquenza (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated for the healing of all grades of erosive esophagitis (erosive GERD) and relief of heartburn associated with Erosive GERD in adults and for the maintenance of healing of all grades of erosive GERD and relief of heartburn associated with Erosive GERD in adults.
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