FDA Approves Oral Suspension for Gastric Ulcers

The FDA has approved Azurity Pharmaceuticals’ Konvomep (omeprazole and sodium bicarbonate). Konvomep is an oral suspension to treat active benign gastric ulcer and reduction of risk of upper gastrointestinal bleeding in critically ill patients.

Azurity officials expect Konvomep will become commercially available in the first quarter of 2023.

“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, Pharm.D., MPH, professor, clinical health professions at St. John’s University College of Pharmacy & Health Sciences, Queens, New York, said in a press release.

In July 2022, the FDA approved Azurity’s Zonisade, an oral suspension of zonisamide to treat partial seizures in adults and pediatric patients aged 16 years and older with epilepsy. This is the first oral liquid form of zonisamide.

Zonisade was developed by Eton Pharmaceuticals, and was one of three drugs sold to Azurity in February 2021. The other two therapies include lamotrigine and topiramate. Topiramate was approved by the FDA in November 2021 with the brand name of Eprontia.