OLDSMAR, Fla.– Kesin Pharma Corporation, a pharmaceutical company focused on innovative Specialty brands and Unit Dose formulations, announced today that the U.S. Food and Drug Administration (FDA) has approved LIKMEZ™ (metronidazole) oral suspension, 500 mg/5 mL.
Available now, LIKMEZ™ is the first and only FDA-approved ready-to-use oral liquid metronidazole in the U.S. market. LIKMEZ™ is a novel presentation of a mainstay antibiotic drug, reinvented to address common adherence issues. Kesin is the exclusive U.S. commercialization partner for LIKMEZ™ through its collaboration with Saptalis Pharmaceuticals, LLC, the developer and NDA holder of the product.
LIKMEZ™ is a novel proprietary liquid formulation of metronidazole for patients who may struggle with dysphagia, difficulty swallowing, or high taste sensitivities. These potential compliance and persistency obstacles can lead to treatment discontinuation and inefficient treatment outcomes, including rebound infection.
LIKMEZ™ is approved for the treatment of trichomoniasis and anaerobic bacterial infections in adults and amebiasis in adults and pediatric patients. LIKMEZ™ comes in a 200 mL bottle as a strawberry peppermint flavored suspension, with a 24-month shelf life and does not require refrigeration. Metronidazole has been shown to be carcinogenic in mice and rats, and the most common adverse reactions to metronidazole include nausea, headache, anorexia, vomiting, diarrhea, abdominal cramping, epigastric distress, and constipation.
LIKMEZ™ addresses inherent risks associated with crushing tablets for those patients needing a liquid formulation and eliminates the potential inconsistences associated with extemporaneously compounding metronidazole prescriptions. Additionally, compounding can amplify the pronounced bitter, metallic taste of metronidazole tablets, which can also negatively influence patients’ adherence to therapy.
“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,” said Narasimhan Mani, President & CEO of Kesin Pharma Corporation. “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,” said Narasimhan Mani.
LIKMEZ™ will be available through most full-line wholesalers and retail pharmacies.
