title: Tobramycin (Cystic Fibrosis Foundation/PathoGenesis).
abstract: TOBI, the inhalant formulation of the antibiotic tobramycin, is a clear, sterile, preservative-free, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed-air driven nebulizer. It was launched in the US in January 1998 for use in cystic fibrosis (CF) patients with chronic pulmonary Pseudomonas aeruginosa infections [315294]. In March 1998, PathoGenesis filed for approval in Canada for this indication, and the Health Protection Branch granted TOBI a Priority Review [281940]. The compound was approved in both Canada and Argentina in February 1999 1312484], and launched in these countries in May 1999 [324276], [326053]. It was approved in Israel in January 2000 [351769] and in Australia in February 2000 [356941] and launched in the two countries in August 2000 [396142]. In March 2000, PathoGenesis and AeroGen Inc agreed to collaborate on developing the use of AeroGen's AeroDose inhaler for the delivery of tobramycin. The aim is to reduce the delivery time from 15 to 20 min to 5 to 10 min. Phase I trials with the inhaler were planned for the second quarter of 2000 [358125] and the product is expected to be in phase III trials by 2002 [396509]. TOBI is also under investigation for the treatment of non-CF patients with lung infection. In June 2000, PathoGenesis initiated a phase II trial of TOBI in bronchiectasis patients with Pseudomonas lung infections to assess whether TOBI improves symptoms associated with severe bronchiectasis [372767].
authors.affiliation: Wyeth-Ayerst Research, Pearl River, NY 10965, USA. singhm@war.wyeth.com
authors.forename: M P
authors.initials: MP
authors.lastname: Singh
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000138:chemical synthesis / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000633:toxicity; D001419:Bacteria / Q000187:drug effects*; D001424:Bacterial Infections / Q000188:drug therapy / Q000382:microbiology; D002986:Clinical Trials as Topic; D000075202:Contraindications; D006801:Humans; D013329:Structure-Activity Relationship; D014031:Tobramycin / Q000009:adverse effects / Q000138:chemical synthesis / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000633:toxicity
chemical_list: D000900:Anti-Bacterial Agents; D014031:Tobramycin