NDAINHALATIONSOLUTION
Approved
Oct 2012
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
5/8 — Partial
BETHKIS (tobramycin inhalation) by Chiesi. Approved for aminoglycoside antibacterial [epc]. First approved in 2012.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BETHKIS is a tobramycin inhalation solution, an aminoglycoside antibacterial administered directly to the lungs to treat chronic Pseudomonas aeruginosa infections in cystic fibrosis patients. It delivers high local concentrations to the site of infection while minimizing systemic exposure and nephrotoxicity risks associated with intravenous aminoglycosides. The drug targets bacterial cell wall synthesis in susceptible gram-negative pathogens.
$0.075MPart D
PeakProduct is in peak revenue stage with modest Part D utilization (18 claims, $75K spending in 2023), suggesting stable but niche market positioning within the CF pulmonary infection segment.
Mechanism of Action
Pharmacologic Class:
Aminoglycoside Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
Started Feb 2017
107 enrolled
Non-cystic Fibrosis Bronchiectasis
Addition of Tobramycin Inhalation in the Treatment of Ventilator Associated Pneumonia
Started Mar 2015
80 enrolled
Ventilator Associated Pneumonia (VAP)
Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles
Started Jan 2014
32 enrolled
Cystic Fibrosis
Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)
Started Aug 2013
60 enrolled
Cystic Fibrosis
Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis
Started Jan 2012
157 enrolled
Pulmonary InfectionsPseudomonas Aeruginosa in Cystic Fibrosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.