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Insmed Announces FDA Clearance of IND for Pivotal Phase 3 Trial of ARIKACE™ in Nontuberculous Mycobacteria Indication
Date:3/21/2011

re organisms found in the soil and water that can cause serious lung disease in susceptible individuals, for which there are currently limited effective treatments. NTM lung disease is often a chronic condition that can lead to progressive inflammation and lung damage, characterized by bronchiectasis and cavitary disease. NTM infections often require lengthy hospital stays for medical management.  Treatment usually involves lengthy multi-drug regimens that can be poorly tolerated and with limited  effectiveness, especially in patients with severe disease or in those who have failed prior treatment attempts.  According to a proprietary SDI Healthcare Database, in the U.S. in 2008, there were approximately 32,000 patients who had a physician office visit for a primary diagnosis of NTM, and about 14,400 patients who had a hospital visit with an NTM diagnosis.

About eFlow® Technology and PARI Pharma

ARIKACE is delivered by an optimized, investigational eFlow® Nebulizer System developed by PARI Pharma and optimized specifically for ARIKACE.  The optimized, investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal formulations via a vibrating, perforated membrane that includes thousands of laser drilled holes.  Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time.  eFlow® Technology is not an ultrasonic nebulizer technology, and it is not a general purpose electronic aerosol generator nebulizer technology.  Combined with its quiet mode of operation, small size, light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments.  PARI Pharma focuses on the development of aerosol delivery devi
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