FDA approves Likmez (metronidazole oral suspension)to treat parasitic and anaerobic bacterial infections
Appili Therapeutics Inc. announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals , LLC received approval from the FDA for Metronidazole Oral Suspension 500mg/5mL (ATI 1501)
ATI 1501, Appili’s liquid oral reformulation of the antibiotic metronidazole, has been licensed to Saptalis for commercialization in the U.S., and other selected territories. The FDA also approved Likmez as the brand name for ATI-1501.
“The FDA approval of Likmez, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili’s ability to identify promising opportunities and develop and monetize them for the benefit of both patients and shareholders,” said Don Cilla, Pharm.D., M.B.A., Appili’s President and CEO. “Difficulty swallowing tablets and capsules should not be a barrier to accessing appropriate antibiotic therapy. Likmez provides a convenient alternative for patients who have difficulty taking solid oral medicines.” Dr. Cilla adds.
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.