Azurity Pharmaceuticals continues its win streak as it bags another approval from the FDA

05 Sep 2022
endpts.com
Drug Review
Massachusetts-based Azurity Pharmaceuticals has been doing well this year in getting its products past FDA approval, and the company is looking to continue that trend Friday.
According to the privately held company, the FDA approved its latest treatment, Konvomep, designed to treat gastric ulcers as well as reduce the risk of upper gastrointestinal bleeding in adults. The treatment itself is a combination of omeprazole, a proton pump inhibitor, and sodium bicarbonate. So far, regulators have only approved it for adults, as the effectiveness in pediatric patients has not been established.
The company stated that the drug will launch commercially starting in Q1 of next year.
“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,” Azurity CEO Richard Blackburn said in a statement.
This is not the only win the company has managed to bag this year. In July, the FDA approved an oral liquid formulation of the drug zonisamide that was originally produced by Eton Pharmaceuticals. That nod gave Azurity the ability to market the treatment, now called Zonisade, as an adjunctive therapy for treating partial seizures in adults and kids 16 years and older who have epilepsy. The green light also came after three double-blind and placebo-controlled clinical studies of the drug were conducted.
Eton sold the oral liquid formulation of the drug to Azurity in a deal last year that was worth up to $45 million. The company also had its grape-flavored oral multiple sclerosis drug Fleqsuvy approved by the FDA in February of this year as well.
Azurity’s approvals also come as the company picked up a recent win in the courts. According to a report from Reuters, a federal appeals court ruled in August that Azurity can pursue a claim that a drug-compounding company, Edge Pharma, sold a “copy” of its FDA-approved antibacterial drug Firvanq using an unapproved ingredient.
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