Kesin Pharma’s Likmez approved by FDA
Kesin Pharma has announced that the US Food and Drug Administration (FDA) has approved Likmez (metronidazole) oral suspension, 500mg/5mL, for patients with adherence hurdles such as dysphagia or difficulty swallowing.
The drug is now available in the US, and is the first and only FDA-approved oral liquid metronidazole on the US market. The novel antibiotic drug was developed in collaboration between Kesin Pharma and Saptalis Pharmaceuticals.
Likmez is approved for the treatment of trichomoniasis and anaerobic bacterial infections in adult patients, and amebiasis in both adult and paediatric patients. The medication is available in a strawberry peppermint flavor.
The most common adverse reactions to the drug included nausea, headache, anorexia, vomiting, diarrhoea, abdominal cramping, epigastric distress and constipation. It has also been shown to be carcinogenic in mice and rats.
Narasimhan Mani, president and CEO of Kesin Pharma, commented: “Likmez is for patients and providers who need a liquid option for those faced with adherence obstacles due to taste sensitivities or difficulty swallowing. An increasing number of patients can benefit from a safe and efficacious product that can support medication adherence. We are very excited with our first brand launch which is part of our upcoming pipeline of novel products, designed to address unmet patient needs and bring value to the healthcare system. We are pleased with our partnership with Saptalis Pharmaceuticals, the NDA holder and manufacturer of Likmez. The timely approval of this NDA505(b)(2) presents a significant opportunity for Kesin Pharma to bring a value-added product to the market.”
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