FDA approves Konvomep for benign gastric ulcers, risk reduction for upper GI bleeding
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The FDA has approved an oral suspension omeprazole and sodium bicarbonate for the treatment of active benign gastric ulcer and to reduce risk for upper gastrointestinal bleeding, according to an Azurity Pharmaceuticals press release.
With this approval, Konvomep – consisting of 2 mg omeprazole and 84 mg sodium bicarbonate per mL after reconstitution – is indicated as a short-term treatment (40 mg once daily for 4-8 weeks) for adults with benign gastric ulcers. It is also indicated as risk reduction for upper GI bleeding in critically ill adult patients, with an initial dosage of 40 mg followed by 40 mg 6-8 hours later and 40 mg once daily for 14 days.
“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,” Olga Hilas, PharmD, MPH, BCPS, BCGP, professor at St. John’s University College of Pharmacy & Health Sciences in New York, said in the press release.
The FDA based its approval, in part, on a U.S. multicenter, double-blind study of two doses of an oral delayed-released formulation of omeprazole vs. placebo in 520 patients with endoscopically diagnosed gastric ulcer, as well as a multinational, double-blind study comparing omeprazole with ranitidine in 602 patients with endoscopically diagnosed gastric ulcer.
The indication for lower upper GI bleeding risk was based on a double-blind, randomized, non-inferiority trial comparing omeprazole and sodium bicarbonate oral suspension 40 mg/1680 mg with intravenous cimetidine in a cohort of critically ill 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,” Richard Blackburn, CEO of Azurity Pharmaceuticals, said in the release. “Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines. Konvomep may give patients, particularly patients with difficulty swallowing pills or capsules, an option for treatment tailored to their needs.”
The most common adverse events reported with Konvomep include abdominal pain, diarrhea, flatulence, headache, nausea and vomiting.
Perspective
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Adrienna Jirik, MD
Proton pump inhibitors have long been the mainstay of therapy for patients with peptic ulcer disease and have shown superiority over H2 receptor antagonists in facilitating healing of peptic ulcers and lowering the rate of GI bleeding.
Most PPI formulations are in a delayed-released tablet or capsule form. In patients with dysphagia or with enteral feeding tubes, the capsule forms can be opened and suspended in a carrier of applesauce, water or juice; however, bioavailability can be affected by the type of PPI, carrier type and volume, timing of ingestion once suspended (to ensure minimal degradation), and manner of ingestion, i.e., chewing of product or possible issues with product sticking in enteral feeding tubes.
Only a few other PPI formulations are currently available in a liquid or granule form but are not widely available at pharmacies and tend to be much more expensive than tablets and capsules. The approval of a new liquid formulation of PPI is promising and will hopefully be more easily accessible and affordable to a broader patient population.
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