FDA approves oral liquid formulation to treat gastric issues

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The FDA has approved Azurity Pharmaceutical’s omeprazole and sodium bicarbonate for oral suspension to treat benign gastric ulcers and is expected to reach commercial markets by next year.

The FDA has approved omeprazole and sodium bicarbonate for oral suspension (Konvomep, Azurity) to treat active benign gastric ulcers and reduce the risk of upper gastrointestinal bleeding in critically ill patients.1

“We are very pleased that patients will soon have access to this FDA-cleared oral liquid formulation option of a commonly prescribed proton pump inhibitor,” said Richard Blackburn, CEO of Azurity Pharmaceuticals, in a press release. hurry.1

Omeprazole and sodium bicarbonate for oral suspension is a combination of omeprazole (PPI) proton pump inhibitor and sodium bicarbonate.2 Proton pump inhibitors are the most commonly prescribed drugs to reduce stomach acid which, in excess, can inflame or irritate the esophagus and cause heartburn or peptic ulcers.3.4

Although they can treat ulcers, PPIs can also prevent ulcers. Many people also take PPIs for gastroesophageal reflux disease (GERD), which occurs when acid backs up into the esophagus, causing tissue inflammation.3

A gastric ulcer line is an open sore that lines the stomach.3 It is one of 2 types of peptic ulcer – the other is called a duodenal ulcer and lines the first part of the small intestine.4 Symptoms of a peptic ulcer include pain, nausea, back pain, burning that feels like hunger pangs, and pain made worse by meals.4

Practitioners test for a peptic ulcer by measuring serum gastrin in a lab, doing barium contrast radiology (x-rays) of the upper gastrointestinal tract, or performing gastrointestinal endoscopy to examine the lining of the upper gastrointestinal tract .4

Treatment for gastric ulcers and bleeding can take many forms, but Omeprazole and Sodium Bicarbonate for Oral Suspension is a liquid formulation.1

“Patients who have difficulty taking solid oral dosage forms may be overlooked and have historically had limited FDA-approved treatment options available as liquid formulations,” said Olga Hilas, PharmD, MPH, BCPS, BCGP. , professor, Clinical Health Professions, St. John’s University College of Pharmacy & Health Sciences, Queens, New York, in a news release.1

Common PPIs are lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (AcipHex), and esomeprazole (Nexium).3 They are the strongest stomach acid blocker that has been shown to be effective for chronic gastrointestinal issues.3 Omeprazole and sodium bicarbonate for oral suspension are expected to be commercially available in 2023.1

“Patients are our priority, and our goal is to bring them new formulations that help them benefit from established medicines,” Blackburn concluded in the press release. treatment tailored to their needs.1

References

  1. Azurity Pharmaceuticals. AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF KONVOMEP™ (omeprazole and sodium bicarbonate for oral suspension). September 2, 2022. Accessed September 2, 2022. https://www.health.harvard.edu/newsletter_article/proton-pump-inhibitors
  2. KONVOmep. KONVOmep website. Accessed September 2, 2022. https://konvomep.com/
  3. Harvard Medical School. Proton pump inhibitors: what you need to know. Harvard Health website. September 30, 2021. Accessed September 2, 2022.
  4. John Hopkins. Peptic ulcer disease. Johns Hopkins Medicine website. Accessed September 2, 2022. https://www.hopkinsmedicine.org/health/conditions-and-diseases/peptic-ulcer-disease

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