The US Food and Drug Administration (FDA) has granted approval to Saptalis Pharmaceuticals, a specialty pharmaceuticals company based in New York, for their metronidazole oral suspension for parasitic and anaerobic bacterial infections, known as ATI-1501. Alongside this approval, the FDA has also greenlit the brand name LIKMEZ for ATI-1501.
Saptalis Pharmaceuticals, in partnership with Appili Therapeutics, developed ATI-1501 as a liquid suspension formulation of the antibiotic metronidazole, designed specifically for patients who face difficulties in tolerating the current tablet form of the medication.
The licensing of ATI-1501 to Saptalis for commercialization in the US and select territories dates back to December 2019. Under this agreement, Saptalis took on the responsibilities of overseeing the regulatory review process, manufacturing, and preparations for the commercial launch of ATI-1501.
With the FDA’s approval and plans for ATI-1501’s commercialization, Appili anticipates receiving milestone payments and royalties from Saptalis.
Metronidazole is prescribed to more than ten million people in the US as a primary oral treatment for parasitic and anaerobic bacterial infections. However, the existing tablet form’s bitter taste and the lack of suitable dosage options have presented challenges for patients who struggle with swallowing, making ATI-1501 a promising alternative.
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