The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for a hybrid tobramycin nebulizer solution (Tobramycin PARI, PARI Pharma GmbH) for chronic pulmonary infection resulting from Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis. More information on the marketing authorization is available on the EMA website.
The hybrid tobramycin solution is a nebulized medication with the same active substance as TOBI Nebuliser solution, but with a different strength (170 mg) and using a different nebulizer device that enables the user to inhale it over a shorter period. TOBI Nebuliser solution was authorized in the European Union on December 10, 1999.
Tobramycin in an aminoglycoside antibiotic that causes rapid concentration-dependent bacterial cell death by targeting bacterial protein synthesis.
"Tobramycin PARI represents an alternative treatment option for cystic fibrosis patients with chronic P. aeruginosa lung infections," according to the EMA news release.
Hybrid applications depend in part on data from preclinical tests and clinical trials of a reference product and in part on new data.
The CHMP recommends clinicians consider official guidance regarding the appropriate use of antibacterial agents. The most frequent adverse effects are cough and dysphonia.
The summary of product characteristics will include detailed recommendations for use of the product and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.
Cite this: Troy Brown. EU Panel Recommends Tobramycin PARI for Pseudomonas in CF - Medscape - Dec 14, 2018.