Phathom Pharmaceuticals has recently introduced a novel treatment for heartburn sufferers with its newly FDA-approved drug, vonoprazan, marketed under the brand name Voquezna. This drug offers a fresh approach to managing gastroesophageal reflux disease (GERD), particularly the most common form of the condition known as non-erosive GERD. This new approval extends Voquezna’s use, following its initial approval to treat patients with esophageal damage due to GERD.
Non-erosive GERD affects a significant portion of the US adult population, with about 15 million of the estimated 45 million patients actively seeking prescription treatments. Traditional management has relied primarily on proton pump inhibitors (PPIs), a class of drugs that reduce stomach acid production to alleviate symptoms. However, Voquezna employs a different strategy by targeting and inhibiting an enzyme system involved in gastric acid secretion, classifying it as a potassium-competitive acid blocker (PCAB).
The FDA’s decision to approve Voquezna for broader use in GERD treatment is supported by a Phase 3 clinical study involving 772 adults who reported frequent heartburn episodes. Results demonstrated that daily administration of Voquezna significantly diminished heartburn symptoms compared to a placebo over the four-week trial period. Some common side effects were noted, including abdominal pain, constipation, diarrhea, nausea, and urinary tract infection. Additionally, some patients encountered upper respiratory and sinus infections during the extended phase of the study. These findings were published in the journal Clinical Gastroenterology and Hepatology.
Phathom Pharmaceuticals, a company based in Florham Park, New Jersey, emerged as a significant player in the gastrointestinal diseases sector following a strategic partnership in 2019 with Takeda Pharmaceutical and Frazier Healthcare Partners. This collaboration led to the formation of Phathom, focusing on the development and commercialization of vonoprazan in the global markets, including the U.S., Europe, and Canada. Successfully raising $181 million through an Initial Public Offering (IPO), Phathom has committed to paying royalties and potentially up to $250 million in sales-based milestones to Takeda.
In addition to its application in GERD, vonoprazan is also FDA-approved, in concert with certain antibiotics, for the treatment of Helicobacter pylori infections. This positions Phathom in direct competition with products like Talicia from RedHill Biopharma, which was approved in 2019. Looking ahead, Phathom is investigating further applications of vonoprazan, targeting other digestive conditions. One such prospective area is eosinophilic esophagitis (EoE), an inflammatory condition of the esophagus. Plans for initiating a Phase 2 trial later this year are underway, which will evaluate vonoprazan’s effectiveness against this disorder. EoE typically responds to corticosteroids, with recent advancements in treatment also coming from other pharmaceutical players like Sanofi and Regeneron with their drug Dupixent, and Takeda with its FDA-approved Eohelia.
Phathom Pharmaceuticals, under the leadership of President and CEO Terrie Curran, heralds the approval of Voquezna as a significant milestone, introducing a unique class of acid suppression therapy to the U.S. market. This boasts potential for greatly improving the quality of life for millions of GERD sufferers, promising more complete and enduring relief from heartburn symptoms. The introduction of vonoprazan not only expands the pharmacological landscape for treating stomach acid-related disorders but also underscores the ongoing innovation within gastrointestinal therapeutics, offering new hope to patients who struggle with these chronic conditions on a daily basis.
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