The regulator also approved LIKMEZ as the brand name for ATI-1501.
Saptalis is a manufacturing and commercialisation partner of Appili Therapeutics, which has developed ATI-1501 as a liquid suspension reformulation of the antibiotic metronidazole for patients who cannot tolerate the current tablet formulation of metronidazole.
ATI-1501 has been licensed to Saptalis for commercialisation in the US, and other select territories in December 2019.
As part of the commercialisation agreement, Saptalis is responsible for overseeing the regulatory review process, manufacturing and preparation for the commercialisation of ATI-1501.
Based on the FDA approval now and commercialisation plans for ATI-1501, Appili expects to get milestone payments and royalties from Saptalis.
In the US, metronidazole is prescribed to over ten million people as a frontline oral treatment to help treat parasitic and anaerobic bacterial infections.
Due to bitter taste and lack of appropriate dosage forms for patients who have difficulty in swallowing, the present form of metronidazole tablet, which is the only other approved oral form in the US market, usually poses treatment compliance challenges.
Appili president and CEO Don Cilla said: “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.
“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.
“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.”