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The open label Phase 2 study was designed to evaluate ARIKACE over multiple treatment cycles in CF patients with Pseudomonas lung infections. The study enrolled 49 patients to receive ARIKACE 560 mg once daily for 28 days of therapy, followed by a 56-day off-treatment observation period. ARIKACE was administered using an optimized, investigational eFlow® Nebulizer System (
The data demonstrated that ARIKACE, delivered once-daily for 28 consecutive days, followed by 56 days off-treatment, for a total of six cycles, resulted in statistically significant improvement in lung function that was sustained over a 72 week period. Specifically, inhalation of 560 mg of ARIKACE produced a mean increase in pulmonary function (FEV1) of 11.7% at the end of the 28 day treatment period of the sixth cycle (p
During the course of the study, FEV1 improvement was also sustained at the end of 56 days off-treatment in each of cycles one through six, with an estimated relative increase in FEV1 of 5.7% (95% CI +3.0%, +8.5%; p=0.0001). Overall, ARIKACE was well-tolerated during all six cycles, with adverse events reported as consistent with those expected in a population of CF patients receiving inhaled medicines.
"ARIKACE demonstrated consistent results of improved lung function throughout all six cycles of this study," said Professor Minic. "In addition, there were no unexpected adverse events associated with the longer term use of the drug. Taken as a whole, these data indicate that ARIKACE has the potential, if approved, to be an important product for CF patients with Pseudomonas lung infections."
ARIKACE also demonstrated statistically significant reduction from baseline in Pseudomonas aeruginosa density, including mucoid strains, which was sustained during the treatment and off-treatment periods of the six cycles. The estimated change from baseline in Log10 CFU over time was -0.6 log (95% CI, -0.2 to -0.9 log; p=0.0030). Mucoid strains of Pseudomonas are often difficult to suppress with antibiotics and play a significant role in progression of CF lung disease. In addition, there was no significant shift in the minimum inhibitory concentration (MIC90) of ARIKACE against Pseudomonas over the course of the six cycles, which suggests a lack of resistance development during the study period.
"These results further strengthen the clinical data package
"We are pleased that the development of ARIKACE continues to proceed expeditiously," said
The data presented today at the 34th
ARIKACE is a registered trademark of Transave, a subsidiary of
ARIKACE has been granted orphan drug status in
About eFlow® Technology and PARI Pharma
ARIKACE is delivered by an 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 devices and comprehensive inhalation drug development to advance aerosol therapies where drug and device can be optimized together. Online at www.paripharma.com.
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