TOBI, a tobramycin inhaled solution, was approved by the U.S. Food and Drug Administration in 1997 as an inhaled version of the antibiotic tobramycin, designed to treat Pseudomonas aeruginosa (pseudomonas) in people with cystic fibrosis. The website About.com states that TOBI reduces the amount of bacteria in the lungs, which can improve lung function and prevent long hospital stays, and as such, has become a current standard of care for cystic fibrosis patients. As an alternative to TOBI, TIP (tobramycin inhalation powder), a potential CF drug, is currently being studied in clinical trials.
According to the drug’s manufacturer, Novartis, TIP is delivered twice daily via a Podhaler, a hand-held, portable, pocket-sized device, as a unique dry powder formulation that produces particles which are light and porous for deep delivery into the lungs. This is compared to TOBI, which is administered also twice daily, but is delivered through a nebulizer. The benefits of TIP over TOBI are that of convenience and safety. According to Novartis, data show that patients completed their tobramycin treatment with TIP in five to six minutes, compared with a 20 minute treatment with TOBI – a 72% reduction in treatment time. Another benefit to TIP over TOBI is that the Podhaler inhalation device is disposable, thereby reducing the risk of bacterial contamination when compared to individuals who use a nebulizer that delivers TOBI, which may not be cleaned properly. Further, data presented in a June 2010 European Cystic Fibrosis Society Conference showed that a TIP Phase III clinical study designed to assess the effectiveness and safety of TIP when compared to TOBI in CF patients showed no significant difference between the two medications in the change of lung function (FEV1) from the study participants’ baseline to the end of the study, per a Novartis press release.
While TIP is not approved for usage in any country at this time, this potential drug was submitted for European Union (EU) regulatory approval in December 2009. Also, in September 2010, the Committee for Medicinal Products for Human Use, which reviews medicines for the EU, issued a positive opinion for TIP as a therapy for chronic pseudomonas in cystic fibrosis patients aged six years and older. Phase III trials for TIP are continuing, after which time it is anticipated that this potential drug will be submitted to the U.S. Food and Drug Administration of approval in the United States.
Sources:
Tobi – Tobramycin Inhalation Solution, About.com
Novartis receives EU approval recommendation for TOBI® Podhaler®, Novartis
Novartis data at European Cystic Fibrosis Society re: TIP (tobramycin inhalation powder), Pharmiweb.com