Saturday, April 20, 2024

FDA Approves Saptalis Pharmaceuticals’ LIKMEZ, a New Form of Metronidazole

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The FDA has approved the brand name LIKMEZ for ATI-1501, a new formulation of the antibiotic metronidazole. ATI-1501, developed by Appili Therapeutics, is a liquid suspension designed for patients who are unable to tolerate the standard tablet form of the medication. Saptalis Pharmaceuticals, a manufacturing and commercialization partner of Appili Therapeutics, has been licensed to commercialize ATI-1501 in the US and select territories since December 2019.

Under the commercialization agreement, Saptalis is responsible for managing the regulatory review process, manufacturing, and preparation for the commercialization of ATI-1501. With the recent FDA approval, Appili Therapeutics expects to receive milestone payments and royalties from Saptalis.

Metronidazole is a frontline oral treatment for parasitic and anaerobic bacterial infections, prescribed to over ten million people in the US. However, the current tablet formulation, which is the only other approved oral form in the US market, often presents treatment compliance challenges due to its bitter taste and difficulties in swallowing for some patients.

LIKMEZ, the newly approved liquid suspension form, offers a convenient alternative for patients who struggle with swallowing solid oral medications. The approval of LIKMEZ is considered an important milestone for Appili Therapeutics, demonstrating its ability to identify and develop promising opportunities, and monetizing them for the benefit of patients and shareholders.

Appili Therapeutics’ President and CEO, Don Cilla, expressed delight that the product will soon be available to patients. He emphasized that difficulties in swallowing tablets and capsules should not be a barrier to accessing appropriate antibiotic therapy and expressed anticipation for bringing additional products to the market to tackle serious global challenges in infectious disease.

The approval of LIKMEZ comes shortly after securing patent coverage through 2039, providing a significant boost for Appili’s commercialization efforts and plans.

The introduction of LIKMEZ, a new form of metronidazole, addresses a significant need in patient care by providing an alternative to tablet medication for patients unable to swallow them. This development reflects the commitment of Appili Therapeutics and Saptalis Pharmaceuticals to improving treatment options and overcoming challenges in the field of infectious diseases.

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