Salvat Laboratory submits application to the U.S. FDA for approval of Clotrimazole, a pioneering drug for the treatment of otomycosis

  • The new drug will be the only one on the market in the United States and Europe specifically formulated and indicated for the topical treatment of fungal otitis externa.
  • Salvat has invested 22 million euros in this project with which reinforces its position as a leading laboratory in the field of otology at an international level.

Salvat, an international pharmaceutical company focused on the development, manufacturing and commercialization through partners worldwide of products such as Otovel and Cetraxal, has submitted the new drug application (NDA) for Clotrimazole to the FDA, the new treatment for fungal otitis externa.

The company thus begins the procedures to launch the new drug in the American market, where it is expected to be available in summer 2023.

For Alberto Bueno, CEO of Salvat, “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”.

Single and cutting-edge drug in otology

Salvat’s Clotrimazole represents a breakthrough in the treatment of this type of otitis externa since it will be the first and only existing drug in the United States and Europe specifically indicated to treat this pathology. While there are other medications or formulations on the market that can help managing the symptoms of this condition, Salvat’s bet is the only one focused on effectively treating otomycosis.

Salvat has specifically formulated Clotrimazole for otic use in the form of single-dose vials, making it easier for patients to use. 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.

Years of research with exceptionally good results

The new drug has undergone two demanding clinical trials to evaluate its efficacy and safety. The trials have been conducted over 3 years in more than 400 adult patients affected by otomycosis, from hospitals in the United States, Mexico, and Europe.

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).

Investment and manufacturing

Since 2019, Salvat has invested more than 22 million euros in the development of this formulation of Clotrimazole, whose manufacture will be carried out in the plants of Salvat USA Inc. in Tamarac (Florida) and in the plant of Pharmaloop, S.L. in Alcalá de Henares (Madrid). Both companies are subsidiaries of Laboratorios Salvat S.A.

Salvat, pioneer in Otolaryngology

Salvat is one of the top pharmaceutical companies in developing and commercializing innovative otology products. Also, Salvat is the first to develop and commercialize otic drug products in single-dose vials worldwide. Otolaryngologists recognize Salvat as the number 1 company in the development of treatments for otology. This new drug for the treatment of otomycosis confirms Salvat’s commitment to this medical specialty and the company’s willingness to strengthen its leadership in the treatment of ear diseases.