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Insmed Incorporated Message Board

  • mitchcarr Jan 19, 2014 12:11 PM Flag

    From an article on the "medicine research Board website:

    From an article on the "medicine research Board website:

    Section 4.2. Aminoglycosides
    Despite the registration of two TIS formulations, significant nonadherence to this agent exists, likely due to the burden associated with drug administration (12 to 20 minutes twice daily) and nebulizer cleaning/disinfection. Tobramycin inhalation powder (TIP), a light, porous-particle formulation, was developed using PulmoSphere® (Inhalation Therapeutic Systems, San Carlos, CA, USA) technology to deliver tobramycin via a simple, capsule-based dry powder inhaler.55 The delivery efficiency to the lungs is about 3 times greater with TIP than with nebulized TIS, with delivery of a 4‐capsule, 112‐mg dose taking only 5 minutes, without the need for device cleaning.56 The phase 3 EVOLVE clinical trial, which was conducted in a relatively undertreated CF population, demonstrated significant positive changes in pulmonary function, sputum P. aeruginosa density, respiratory-related hospitalization, and antipseudomonal antibiotic use in the TIP vs. placebo groups.57 In the EAGER trial, TIP was compared with TIS over three treatment cycles and was found to have comparable efficacy, but higher treatment satisfaction scores and a much shorter administration time.58 In these studies, the main side effect associated with the use of TIP was cough. TIP was recently approved in Canada, Chile, and Europe (TOBI® Podhaler®, Novartis Pharmaceuticals, Basel, Switzerland)

    A liposomal formulation of amikacin is being developed for inhalation via an investigational eFlow®59 device (Arikace®, Insmed Incorporated, Monmouth Junction, NJ, USA).60 The liposomes have been shown to penetrate biofilms in vitro.61 Additionally, virulence factors secreted by P. aeruginosa facilitate the release of amikacin from liposomes, thus targeting the drug to the bacterial microenvironment.61 Whether this occurs in vivo is unclear, but the “Trojan horse” concept of introducing antibiotics into a biofilm is attractive

    Sentiment: Hold

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