FDA-Approved Konvomep Releases To Public


The drug is a rare FDA-approved liquid formulation that treats ulcers and lowers risk of gastrointestinal bleeding in chronically ill patients.

Azurity Pharmaceuticals announced1 in September of 2022 that its drug Konvomep had gained FDA approval, and it is now available to the public as Q1 2023 winds down.

Konvomep is intended for chronically ill patients who are experiencing benign ulcers or hoping to reduce their chances of upper gastrointestinal bleeding.

A liquid formulation provides easier administration for individuals who struggle to swallow pills, says the release. Azurity CEO Richard Blackburn was quoted in the statement from September, saying “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.”

Stomach ulcers are relatively common in the US, with over 4 million Americans experiencing one each year, according to Harvard Health.2 Though most common in women older than 60—individuals of any age, gender or race can develop an ulcer. Burning pain in the upper abdomen a few hours after eating is perhaps the most common symptom of an ulcer.

Those ulcers can lead to gastrointestinal bleeding, which can in turn lead to shock or anemia. “Gastrointestinal (GI) bleeding is a symptom of a disorder in your digestive tract,” says Mayo Clinic. “The blood often appears in stool or vomit but isn't always visible, though it may cause the stool to look black or tarry. The level of bleeding can range from mild to severe and can be life-threatening.”3

The statement from Azurity went on to address the lack of FDA-approved liquid formulations, saying people who are unable to swallow pills have had limited treatment options in the past. And though Konvomep is not the first FDA-approved treatment for ulcers or gastrointestinal bleeding, it is unique in its formulation as a liquid.

Not being able to swallow pills is a problem many individuals have, and benign ulcers are not uncommon. A treatment like Konvomep hopes to patch up the disconnect between people who fall into both demographics.

This is not the first time Azurity has gotten a liquid formulation drug passed by the FDA. In Q2 2022, the pharma company won FDA approval for Zonisade, an epilepsy drug. Much like with the passing of Konvomep, Azurity said in its statement about Zonisade that it “Addresses an important unmet need in patients who have difficulty swallowing or who are unable or unwilling to take tablets.”4

Azurity is finding a niche—but incredibly important—market. On the website5 for Konvomep, the intended benefits are laid out, including a co-pay as low as 5 dollars, and discounts that automatically apply at pharmacies.

Azurity also says that Konvomep has “Generally better coverage than compounded formulations."

1. Azurity Pharmaceuticals, inc. announces FDA approval of konvomep™ (omeprazole and sodium bicarbonate for oral suspension). Press release. September 2, 2022. Accessed March 31, 2023. https://azurity.com/azurity-pharmaceuticals-inc-announces-fda-approval-of-konvomep-omeprazole-and-sodium-bicarbonate-for-oral-suspension/#:~:text=(September%202%2C%202022)%20%E2%80%93,omeprazole%20and%20sodium%20bicarbonate%20for
2. Peptic Ulcer. Harvard Health. December 29, 2014. Accessed March 31, 2023. https://www.health.harvard.edu/digestive-health/peptic-ulcer-overview#:~:text=Peptic%20ulcers%20are%20sores%20in,can%20occur%20at%20any%20age.
3. Gastrointestinal bleeding overview. Mayo Clinic. October 15, 2020. Accessed March 31, 2023. https://www.mayoclinic.org/diseases-conditions/gastrointestinal-bleeding/symptoms-causes/syc-20372729#:~:text=Gastrointestinal%20(GI)%20bleeding%20is%20a,and%20can%20be%20life%2Dthreatening.
4. After rejection, Azurity gets FDA nod for liquid epilepsy drug. Fierce Pharma. July 19, 2022. Accessed March 31, 2023. https://www.fiercepharma.com/pharma/after-rejection-azurity-gets-fda-nod-liquid-epilepsy-drug
5. KONVOMEP liquid omeprazole for patients. Frequently Asked Questions. Azurity Pharmaceuticals. Published 2023. Accessed March 31, 2023. https://konvomep.com/patients/faq/
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