The Food and Drug Administration (FDA) has approved Konvomep™ (omeprazole and sodium bicarbonate for oral suspension) for the short-term treatment (4 to 8 weeks) of active benign gastric ulcer and for the reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients.
Konvomep contains 2mg of omeprazole, a proton pump inhibitor, and 84mg of sodium bicarbonate per mL after reconstitution. The effectiveness of Konvomep has been established, in part, based on studies of an oral delayed-release omeprazole product for the treatment of active benign gastric ulcer, as well as studies of another omeprazole and sodium bicarbonate oral suspension product for the reduction of risk of upper GI bleeding in critically ill adult patients.
“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. “Konvomep may give patients, particularly patients with difficulty swallowing pills or capsules, an option for treatment tailored to their needs.”
Konvomep is supplied as a kit containing 2 bottles: 1 bottle of omeprazole and 1 bottle of premeasured strawberry-flavored slightly hazy red diluent containing sodium bicarbonate. Prior to dispensing, Konvomep must be reconstituted by a health care provider; the product is available in 90mL, 150mL, and 300mL bottles.
The sodium content of Konvomep should be taken into consideration when administering to patients on a sodium-restricted diet or those at risk for developing congestive heart failure. The total content of sodium, from active and inactive ingredients per mL of reconstituted Konvomep is 26.3mg (1.14mEq). Total sodium content per 40mg dose (volume of 20mL) of Konvomep is 526mg (22.8mEq).
Konvomep is expected to be available in the first quarter of 2023.
- Azurity Pharmaceuticals, Inc. announces FDA approval of Konvomep™ (omeprazole and sodium bicarbonate for oral suspension). News release. Azurity Pharmaceuticals, Inc. Accessed September 2, 2022. https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-inc-announces-fda-approval-of-konvomep-omeprazole-and-sodium-bicarbonate-for-oral-suspension-301616983.html
- Konvomep. Package insert. Azurity Pharmaceuticals, Inc.; 2022. Accessed September 2, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213593s000lbl.pdf