FDA Approves Liquid Form of Antibiotic for The Treatment of Infection

The FDA has approved metronidazole (Likmez; Kesin Pharma Corporation) oral suspension, 500 mg/5mL, a liquid form of the original antibiotic, for patients that have difficulty swallowing, dysphagia, or high taste sensitivities and struggle to adhere to the original antibiotic, according to a recent press release. The 200 mL bottle features a strawberry peppermint flavored suspension with a 2-year shelf life and no refrigeration requirements.¹

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“An increasing number of patients can benefit from a safe and efficacious product that can support medication adherence,” said Narasimhan Mani, PhD, MBA, President & CEO of Kesin Pharma Corporation, in the press release. “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.”¹

Metronidazole is indicated to treat trichomoniasis and anaerobic bacterial infections in adults. It is also used for treatment of amebiasis in adults and pediatric patients, according to the press release.¹

Metronidazole works by inhibiting protein synthesis in the susceptible organism, which will eventually cause cell death, according to a StatPearls article.² The most common adverse events (AEs) associated with metronidazole include gastrointestinal (GI) issues (i.e., nausea) and accompanying symptoms (headache, anorexia, and occasional vomiting, diarrhea, epigastric distress, and abdominal cramping). Other AEs may include unpleasant taste in the mouth, dermatologic and hematopoietic issues, and hypersensitivity.1

Trichomoniasis is a common but treatable sexually transmitted disease (STD) caused by a parasitic protozoa called Trichomonas vaginalis.^2,3 The majority of patients with trichomoniasis do not have symptoms, but the most common (in both men and women) include itching or irritation of the genitals and discomfort related to urination.³

Although anaerobes are part of the body’s indigenous flora, anaerobic bacterial infections can occur when there is a disruption of the mucosal surface, allowing the bacteria to enter deep tissue. It is common for infection to occur at a site of trauma on the body, after surgery, or from tissue necrosis.⁴

Amebiasis is a disease caused by a parasite called Entamoeba histolytica. The spread of this one-celled parasite most often occurs because people were exposed to poor sanitary conditions in tropical locations or institutions, but men who have sex with men are also at higher risk. Only 10% to 20% of infected individuals will have symptoms, which are commonly mild and include loose feces, stomach pain, and stomach cramping.⁵

The new suspension will be available in many retail stories and wholesale suppliers.¹

“The timely approval of this [application] presents a significant opportunity for Kesin Pharma to bring a value-added product to the market,” Mani said in the press release.¹

References

1. Kesin Pharma Announces FDA Approval and U.S. Availability of LIKMEZ™(metronidazole) Oral Suspension. News Release. November 14, 2023. Accessed on November 14, 2023. https://www.businesswire.com/news/home/20231113847261/en

2. Weir CB, Le JK. Metronidazole. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023. https://www.ncbi.nlm.nih.gov/books/NBK539728/

3. Fact Sheet. Centers for Disease Control and Prevention. Article. Accessed November 14, 2023. https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm

4. Noor A. Khetarpal S. Anaerobic Infections. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023. https://www.ncbi.nlm.nih.gov/books/NBK482349/

5. General Information: What is amebiasis? Centers for Disease Control and Prevention. Article. Accessed on November 14, 2023. https://www.cdc.gov/parasites/amebiasis/general-info.html