Salvat Submits NDA for Ear Infection Drug

If approved, clotrimazole would be the first topical drug indicated to treat otomycosis, an ear infection caused by a fungus.

Madrid, Spain-based Salvat has submitted a new drug application (NDA) for a new treatment for fungal otitis externa, clotrimazole, to the FDA. The pharmaceutical manufacturer expects the drug, if approved, to be available in the United States by the summer of 2023. Company officials said that clotrimazole would be the first topical drug indicated to treat otomycosis, an ear infection caused by a fungus. It usually affects the outer ear canal.

“While there are other medications or formulations on the market that can help manage the symptoms of this condition, Salvat’s….is the only one focused on effectively treating otomycosis,” the company said.

Salvta enters a potentially lucrative market as the value of fungal otitis external medications was estimated at $169 million in 2021, according to Coherent Market Insights. The group of medications is expected to produce a compounded annual growth rate of 2.9% from 2021 through 2028.

“This project is a reflection of the firm commitment we have made to R&D in the area of otology, and reinforces our leadership position in this therapeutic area, without losing focus on other areas of strategic growth for Salvat,” said Alberto Bueno, CEO of Salvat.

Salvat formulated clotrimazole for otic use in the form of single-dose vials, making it easier for patients to use, according to the company. “This format also ensures the sterility of the product and, by containing the necessary amount of active ingredient, also warrants the correct use of the drug,” Salvat said.

The NDA is based on two clinical trials conducted over three years in more than 400 adult patients affected by otomycosis. “Both studies have concluded with very positive results that confirm the efficacy and safety of the new drug for the eradication of the fungus that causes otomycosis and the associated clinical symptoms (pain, itching, feeling of fullness and hearing loss),” Salvat said.

Since 2019, Salvat has invested more than 22 million euros ($23 million) to develop this formulation of clotrimazole. Salvat also manufactures Otovel (ciprofloxacin and fluocinolone acetonide), a combination antibiotic and steroid medication for ear infections, and Cetraxal (ciprofloxacin) to treat acute otitis externa caused by ciprofloxacin susceptible microorganisms.