The FDA approved Azurity Pharmaceutical’s Omeprazole and Sodium Bicarbonate for Oral Suspension for the treatment of benign stomach ulcers and is predicted to reach commercial markets next year.
The FDA has approved omeprazole and sodium bicarbonate for oral suspension (Konvomep, Azurity) to treat active benign ulcers and reduce the risk of upper gastrointestinal bleeding in critically ill patients.1
“We are very excited 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 commonly prescribed drug to reduce stomach acid, which in excess can inflame or irritate the esophagus and cause heartburn or ulcers.3.4
While they can treat ulcers, PPIs can also prevent ulcers. Many people also take PPIs for gastroesophageal reflux disease (GERD), which occurs when acid travels up the esophagus and inflames the tissue.3
A gastric ulcer line is an open sore that lines the stomach.3 It is one of 2 types of stomach ulcers – the other is called a duodenal ulcer and lines the first part of the small intestine.4 Symptoms of an ulcer include pain, nausea, back pain, a burning sensation that feels like hunger pain, and pain that is made worse with meals.4
Practitioners test for an ulcer by measuring serum gastrin in a lab, performing a barium contrast radiology (X-ray) of the upper GI tract, or performing a gastrointestinal endoscopy to examine the mucous membranes of the upper GI tract.4
Treatment of ulcers and bleeding can take many forms, but omeprazole and sodium bicarbonate for oral suspension is a liquid formulation.1
“Patients who struggle with taking solid oral dosage forms can be overlooked and historically have 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 include lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (AcipHex), and esomeprazole (Nexium).3 They are the most potent antacid proven to be effective for chronic gastrointestinal problems.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 provide them with new formulations that help them take advantage of established drugs,” Blackburn concluded in the press release. “Konvomep™ can give patients, especially those who have difficulty swallowing pills or capsules, an option for treatment tailored to their needs.”1
- Azure 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
- CONVOmep. KONVOmep website. Accessed September 2, 2022. https://konvomep.com/
- Harvard Medical School. Proton pump inhibitors: what you need to know. Harvard Health website. September 30, 2021. Accessed September 2, 2022.
- Johns Hopkins. Disease of stomach ulcer. Johns Hopkins Medicine website. Accessed September 2, 2022. https://www.hopkinsmedicine.org/health/conditions-and-diseases/peptic-ulcer-disease