FDA Approves Likmez (metronidazole) Oral Suspension for the Treatment of Parasitic and Anaerobic Bacterial Infections

September 25, 2023 - Appili Therapeutics Inc., announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC received approval from the U.S. Food and Drug Administration for Metronidazole Oral Suspension 500mg/5mL (ATI-1501). ATI-1501. The FDA also approved Likmez^TM as the brand name for ATI-1501.

Metronidazole is a widely used frontline oral treatment with over 10 million prescriptions written in the United States every year to help treat parasitic and anaerobic bacterial infections. The current tablet form of metronidazole is the only other approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges.

Likmez^TM is the first and only FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections that addresses the unmet need in patients with dysphagia and avoids risks associated with drug compounding, and discontinuation related anti-microbial resistance.

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