Kesin Pharma has obtained approval from the US Food and Drug Administration (FDA) for its oral suspension antibiotic drug Likmez (metronidazole), designed for patients with dysphagia and difficulty swallowing.
Indicated for the treatment of trichomoniasis in adults, amebiasis in both adults and pediatric patients and anaerobic bacterial infections in adults, Likmez is available as an oral suspension, with each 5 mL containing 500 mg of metronidazole.
This liquid formulation of metronidazole is the sole FDA-approved liquid option, offering a groundbreaking prescribing alternative for patients encountering difficulties in swallowing or facing taste-related obstacles.
“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 and CEO of Kesin Pharma, in the company’s press release.
Kesin Pharma is headquartered in New York and focuses on the development, manufacturing and commercialization of generic and innovative products in liquid and semi-solid dosage forms.
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How Does Likmez Work?
Likmez offers a safer alternative by mitigating the associated risks linked to off-label drug compounding.
The active ingredient, metronidazole, classified as a nitroimidazole antimicrobial drug, exerts antibacterial effects in anaerobic environments against most obligate anaerobes. Following passive diffusion into the organism, metronidazole is activated in the cytoplasm of susceptible anaerobic bacteria through reduction. The reduced form of metronidazole, along with free radicals, interacts with DNA, inhibiting DNA synthesis and causing DNA degradation, ultimately leading to the demise of the bacteria.
It is essential to recognize that in order to minimize the emergence of drug-resistant bacteria and preserve the efficacy of Likmez and other antibacterial drugs, Likmez should be employed solely for the treatment or prevention of infections that are confirmed or strongly suspected to be bacterial in origin.
Likmez is available in a 200 mL bottle, featuring a strawberry peppermint flavor in suspension form. With a 24-month shelf life and no need for refrigeration, Likmez provides a convenient option for patients.
This formulation addresses the risks associated with crushing tablets, particularly for those requiring a liquid form, and eliminates potential inconsistencies linked to the extemporaneous compounding of metronidazole prescriptions. Moreover, compounding can intensify the naturally bitter, metallic taste of metronidazole tablets, potentially adversely impacting patients’ adherence to therapy.
The FDA’s endorsement of Likmez is robustly backed by compelling clinical evidence, affirming its efficacy as a viable treatment choice.
Additionally, the most frequently observed adverse reactions associated with metronidazole include nausea, headache, anorexia, vomiting, diarrhea, abdominal cramping, epigastric distress and constipation.
Alternative Products in the Market
In addition to the oral suspension Likmez, there are alternative FDA-approved treatments for similar indications.
Pfizer markets Flagyl (metronidazole) tablets, which come in 50 mg or 500 mg strengths as an oral formulation of the synthetic nitroimidazole antimicrobial. This medication is also indicated for the treatment of Trichomonas vaginalis infection in both females and males when the presence of the trichomonad has been confirmed through appropriate laboratory procedures such as wet smears and/or cultures. Flagyl is also available in an intravenous injection (IV) form, employed to address severe bacterial infections in various body regions. Furthermore, it is used to prevent infections in the bowels before and after surgery for certain patients.