FDA Approves Oral Liquid Formulation to Treat Gastric Issues

The FDA approved Azurity Pharmaceutical’s omeprazole and sodium bicarbonate for oral suspension to treat benign gastric ulcers and it is predicted 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-approved oral liquid formulation option of a commonly prescribed proton pump inhibitor," said Richard Blackburn, CEO of Azurity Pharmaceuticals, in a press release.1

The omeprazole and sodium bicarbonate for oral suspension is a combination of proton pump inhibitor omeprazole (PPI) with sodium bicarbonate.2 Proton pump inhibitors are the most common prescribed drug to reduce stomach acid which, in excess, can inflame or irritate the esophagus and cause heartburn or peptic ulcers.3,4

While they can treat ulcers, PPIs can prevent ulcers as well. Many individuals also take PPIs for gastroesophageal reflux disease (GERD), which occurs when acid travels up the esophagus, inflaming the tissue.3

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

Practitioners test for a peptic ulcer by measuring serum gastrin in a lab, performing a Barium contrast radiology (X-ray) of the upper gastrointestinal tract, or performing a gastrointestinal endoscopy to examine the mucous lining of the upper gastrointestinal tract.4

Treatment for gastric ulcers and bleeding can take many shapes, but omeprazole and sodium bicarbonate for oral suspension is a liquid formulation.1

"Patients who struggle with 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 press release.1

Common PPIs are lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (AcipHex), and esomeprazole (Nexium).3 They are the most potent stomach acid inhibitor that is proven effective for chronic gastrointestinal issues.3 Omeprazole and sodium bicarbonate for oral suspension is projected to be commercially available in 2023.1

"Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines,” concluded Blackburn in the press release. “Konvomep™ may give patients, particularly patients with difficulty swallowing pills or capsules, an option for 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 on September 2, 2022.https://www.health.harvard.edu/newsletter_article/proton-pump-inhibitors
  2. KONVOmep. KONVOmep website. Accessed on 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 on September 2, 2022.
  4. Johns Hopkins. Peptic Ulcer Disease. Johns Hopkins Medicine website. Accessed September 2, 2022. https://www.hopkinsmedicine.org/health/conditions-and-diseases/peptic-ulcer-disease