Hetero Healthcare Ltd Launches Hetran- A New Era in Acid Blocker Therapy

Understanding the growing need for effective gastric acid related diseases treatment, Hetero Healthcare Ltd, one of India's leading generic pharmaceutical companies, has announced the launch of Vonoprazan, a new-age acid blocker, under the brand name Hetran.

Hetran tablets, containing Vonoprazan fumarate, are available in 10mg and 20mg dosage strengths. Vonoprazan is a novel, orally active Potassium-Competitive Acid Blockers (P-CAB), indicated for the treatment of gastric and duodenal ulcers, reflux esophagitis, prevention of low-dose aspirin- or nonsteroidal anti-inflammatory (NSAIDs) drug-related gastric and duodenal ulcers, and as an adjunct to Helicobacter pylori eradication associated with gastric ulcers, duodenal ulcers, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, post-endoscopic resection of early-stage cancer, or Helicobacter pylori gastritis¹.

Hetero Healthcare's introduction of Hetran in India marks an advancement in the management of acid-related disorders. Vonoprazan, the novel US-FDA-approved P-CAB, may offer rapid and sustained relief compared to available therapies, addressing the unmet needs of gastric acid disorders and acid peptic disease(APD) management.

Speaking about the launch Mr Sandeep Shastri, Executive Director at Hetero Healthcare Ltd, stated, "With the launch of Vonoprazan as Hetran in India, we aim to relieve patients suffering from gastric acid disorders. PPIs fail in up to 40% of reflux diseases patients. Various studies shows Vonoprazan's superior efficacy in treating gastric acid-related disease, offering rapid and sustained relief. We proudly bring this new-age acid blocker to India as the basic manufacturers of Vonoprazan."

Dual Brunt in Reflux esophagitis - Pervasiveness of Problem and Therapeutic Gaps

Gastric acid related disorders are rapidly becoming one of India's most common health issues, affecting nearly 3 in 10 people². With lifestyle transitions and rising obesity rates, the burden of these diseases is increasing. This condition, marked by the reflux of gastric contents into the esophagus, leads to persistent heartburn, regurgitation, and chest discomfort. It also disrupts sleep, causing frequent awakenings and increased wakefulness, making restful nights challenging.

Potassium-Competitive Acid Blockers (P-CABs): A New Era for the Treatment of Acid-Related Diseases

Traditional therapies available in India include antacids, antihistamines (H2 receptor antagonists), and proton pump inhibitors (PPIs). For patients with occasional or mild symptoms, treatments such as antacids and histamine H2 receptor blockers (H2RAs) may be effective, while proton pump inhibitors (PPIs) are recommended for those with frequent or severe symptoms. However, up to 40% of these patients do not respond adequately to currently available therapies³.

Vonoprazan: A Novel US-FDA Approved P-CAB

Vonoprazan, a novel, orally active P-CAB, offers significant advancements in acid suppressant therapy. It provides several advantages over PPIs, including acid stability, rapid onset, less variability due to CYP2C19 polymorphisms, and extended half-lives, enhancing clinical utility. Unlike other therapies, P-CABs like Vonoprazan are acid-stable, do not require enteric coating, and act immediately at the proton pump without the need for pre-meal dosing. Its rapid absorption reaches peak plasma concentration within two hours and maintains prolonged acid suppression⁴.

Vonoprazan: Snapshot of Scientific Evidence

Vonoprazan is proven to be 400 times more effective than PPIs in pre-clinical studies due to its pH stability⁵. In a multicenter, randomized, double-blind study, patients with endoscopically confirmed erosive esophagitis received vonoprazan 20 mg or lansoprazole 30 mg daily. Vonoprazan healed 99.0% of patients by week 8, compared to 95.5% for lansoprazole⁶. Subgroup analysis indicates that vonoprazan is more effective than PPIs for patients with severe erosive esophagitis, with safety outcomes similar to those of PPIs⁷. In another study conducted in South Asia, a prospective observational cohort of 1,642 patients orally treated with vonoprazan at doses of 10 mg or 20 mg, once or twice daily showed that 78.13% of patients had good treatment compliance with vonoprazan therapy⁸. Vonoprazan fumarate, tested at doses ranging up to 120 mg, was safe and well tolerated in Asian subjects, with no reported adverse events⁹.

Vonoprazan- Snapshot of Guidelines Considerations

The Japanese Society of Gastroenterology also recommends vonoprazan for initial and maintenance treatment of severe reflux esophagitis. For mild cases, using either vonoprazan or PPIs for initial treatment is suggested; and recommend considering vonoprazan for maintenance therapy ¹⁰.

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