Appili Therapeutics announces U.S. FDA approval of LIKMEZ

Appili Therapeutics announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals, received approval from the U.S. Food and Drug Administration 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 “Appili was formed to develop ATI-1501 and it is exciting to see our first development project make it to market. This is a tremendous team accomplishment. We are all delighted that the product will soon be available to patients and we look forward to bringing additional products to market that tackle serious global challenges in infectious disease.”