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Finafloxacin: first global approval.
1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand, dru@adis.com.
Drugs
|March 27, 2015
Summary
Finafloxacin, a fluoroquinolone antimicrobial, is effective in acidic conditions. Its otic suspension (Xtoro™) is now approved for acute otitis externa, marking a key development milestone.
Area of Science:
- Pharmacology
- Microbiology
- Drug Development
Background:
- Finafloxacin is a fluoroquinolone antimicrobial with optimal efficacy in acidic environments.
- It is being developed for bacterial infections in acidic conditions, such as urinary tract infections and H. pylori infections.
Purpose of the Study:
- To summarize the development milestones of finafloxacin.
- To highlight the recent approval of an otic suspension for acute otitis externa.
Main Methods:
- Review of finafloxacin development pipeline.
- Summary of clinical trial phases and regulatory approvals.
Main Results:
- Finafloxacin otic suspension (Xtoro™) approved in the USA for acute otitis externa.
- Oral and intravenous formulations are in Phase I/II trials for UTIs and H. pylori infections.
Conclusions:
- The approval of finafloxacin otic suspension represents a significant milestone in its development.
- Further development is ongoing for oral and intravenous formulations targeting various infections.
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