Appili Gets FDA Approval for Liquid, Oral Reformulation of Anti…

Appili Therapeutics announced on Monday that the FDA has approved its liquid oral reformulation of the antibiotic metronidazole, ATI-1501, for the treatment of antimicrobial infections in patients with difficulty swallowing pills or who are unable to get injections.

The drug is a prominent oral treatment with more than 10 million U.S. prescriptions annually. The injectable form of the drug, commonly used for treating parasitic and anaerobic bacterial infections, has been in shortage in the U.S. since last year due to extreme demand and regulatory delays, according to the American Society of Health-System Pharmacists

“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,” according to Appili.

Before the FDA’s approval of liquid metronidazole, the pill form had to be crushed and resuspended in food or drinks for patients who had difficulty swallowing. This posed a risk for dosing errors and did not help with its bitter taste. Appili’s reformulated liquid suspension of metronidazole diminishes its taste and makes administration easier and more effective, according to the company.

Appili said in Monday’s announcement that Saptalis Pharmaceuticals, its privately held partner, will sell the drug under the brand name Likmez in the U.S. The company expects to receive milestone payments and royalties from Saptalis in upcoming quarters, given the drug approval and Saptalis’ commercialization plans.

“Likmez is the first and only FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections that addresses the unmet need in patients with dysphagia and avoids risks associated with drug compounding, and discontinuation related anti-microbial resistance,” according to Appili.

Given that patients in hospital settings and those with severe infections have been most strongly impacted by the shortage, the approval of Appili’s drug is expected to increase supply and access. “It won’t completely solve the shortage but it could be very helpful,” Erin Fox, senior director of drug information at the University of Utah Health, told Reuters.

However, some experts disagreed regarding the impact of approval. “The liquid form will be useful for certain types of infections, but it may not replace the intravenous formulations. So it will help a certain amount of patients,” David Margraf, a pharmaceutical research scientist at the University of Minnesota’s Center for Infectious Disease Research and Policy, also told the wire service.

“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,” Appili CEO Don Cilla said in a statement “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.”

Appili’s pipeline includes a topical product for the disfiguring skin infection cutaneous leishmaniasis and a live attenuated vaccine against aerosolized bacteria Francisella tularensis, which the National Institutes of Health defines as a Category A pathogen.