Fonseca Biosciences Launches XTORO (finafloxacin otic suspension) 0.3% for Acute Otitis Externa
LONG BEACH TOWNSHIP, N.J. — Fonseca Biosciences, a specialty pharmaceutical company commercializing clinically differentiated pharmaceutical products, today announced the launch of XTORO (finafloxacin otic suspension), 0.3% for the treatment of acute otitis externa (AOE), commonly known as swimmer’s ear, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus. The launch follows FDA approval of the Prior Approval Supplement (PAS) required for commercial manufacturing of XTORO, clearing the final regulatory hurdle to U.S. commercialization.
“Swimmer’s ear, or AOE, is a painful condition that causes significant disruption to daily life, yet there has been little to no innovation in this category for decades. As the first NME approved for AOE in over 20 years, XTORO represents an important treatment option for patients, particularly as antibiotic-resistant cases of AOE continue to emerge,” said Mike Luby, Founder and Chief Executive Officer of Fonseca Biosciences.
“We look forward to bringing XTORO’s differentiated clinical profile, including microbiological activity against key fluoroquinolone-resistant pathogens and rapid pain relief demonstrated in Phase 3 studies, to the millions of patients affected by AOE. As Fonseca’s first product launch, we are eager to deploy our innovative, data-driven commercial model to bring this new treatment option to physicians and the patients they serve.”
To support XTORO’s adoption, Fonseca is also launching the Early Access Resource (EAR) Program, through which treatment will be made available at no cost to healthcare professionals and patients. Participating healthcare professionals will receive samples containing a full treatment course to support early clinical experience with XTORO in appropriate patients. The EAR Program is expected to operate during the initial launch period while supplies last.
Luby continued, “Fonseca is committed to bringing this long-overdue innovation to physicians and patients. Through the EAR Program, healthcare professionals can gain early experience with XTORO in appropriate patients during the initial launch period.”
Eligible healthcare professionals may learn more about XTORO and the EAR Program, as well as request participation, at www.xtoro.us.
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