Launch follows FDA approval of the Prior Approval Supplement required for commercial manufacturing, clearing the final regulatory hurdle to U.S. commercialization of the first new molecular entity (NME) approved for acute otitis externa in more than two decades
LONG BEACH TOWNSHIP, N.J.--(BUSINESS WIRE)--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.
About XTORO® (finafloxacin otic suspension), 0.3%
XTORO (finafloxacin otic suspension), 0.3%, is an FDA-approved topical quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE), commonly known as swimmer's ear, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients one year of age and older.
XTORO contains finafloxacin, a fluoroquinolone that demonstrated clinical and microbiological efficacy in Phase 3 clinical trials, including activity against fluoroquinolone-resistant pathogens and rapid relief of ear pain. XTORO is the first new molecular entity approved for acute otitis externa in more than two decades.
INDICATIONS AND USAGE
XTORO (finafloxacin otic suspension), 0.3%, is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE), with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients one year of age and older.
IMPORTANT SAFETY INFORMATION
Contraindications: None.
Warnings and Precautions:
- Prolonged use of this product may result in overgrowth of non-susceptible organisms. Discontinue use if this occurs.
- Allergic reactions may occur in patients with a history of hypersensitivity to finafloxacin, other quinolones, or any component of this medication. Discontinue use if this occurs.
Adverse Reactions:
The most common adverse reactions occurring in 1% of patients treated with XTORO were ear pruritus and nausea.
Before administering, please see Full Prescribing Information for XTORO® at https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5c628272-019e-4511-8d5c-dcf56023da25
To report SUSPECTED ADVERSE REACTIONS, contact Fonseca Biosciences, LLC at 1-877-436-6732 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Acute Otitis Externa
Acute otitis externa affects millions of patients annually in the United States and is characterized by inflammation and infection of the external ear canal, often resulting in significant pain, tenderness, and swelling.
About Fonseca Biosciences
Fonseca Biosciences is a specialty pharmaceutical company focused on acquiring and commercializing clinically differentiated pharmaceutical products. The company seeks high-quality assets with compelling clinical profiles and significant commercial potential, applying a disciplined, data-driven commercialization model designed to efficiently translate clinical differentiation into physician adoption, patient access, and sustainable market success.
Fonseca's first commercial product is XTORO® (finafloxacin otic suspension), 0.3%, an FDA-approved treatment for acute otitis externa. Through a capital-efficient operating model and integrated commercialization platform, Fonseca is building a portfolio of differentiated pharmaceutical products designed to address meaningful unmet medical needs.
For more information, visit www.fonsecabio.com.
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