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PARI Pharma Receives Approval For Altera Nebulizer System

PARI Pharma has received FDA approval for Altera Nebulizer System that uses eFlow Technology, to market for treating cystic fibrosis patients. It is a portable, drug-specific nebulizer or drug-specific delivery device, used as a respiratory device.

The nebulizer system has been used in the treatment of patients with cystic fibrosis and has been specifically developed to deliver Gilead Sciences’ Cayston (aztreonam for inhalation solution) 75 mg.

PARI Pharma contributed to the approval of Cayston by optimizing the formulation for administration via a specifically customized nebulizer system (brand name Altera) based on eFlow Technology. Altera delivers Cayston in two to three minutes, as evidenced in multiple clinical trials.

Martin Knoch, president of PARI Pharma, said: “Cayston delivered with the Altera offers significant advances to cystic fibrosis patients, especially since this is the first new inhaled antibiotic approved for CF in the last 10 years. By optimizing the drug and the device together, we have a new therapy that has the potential to improve patient adherence through device portability and a significant reduction in treatment time,”

Robert Beall, president and CEO of the Cystic Fibrosis Foundation, said: “We are excited on behalf of the CF community, because the new Altera device allows patients to take an inhaled antibiotic in under three minutes. This reduces patients’ overall treatment burden and increases their quality of life.”

Frank Accurso, professor of pediatrics at the University of Colorado, Denver and Children’s Hospital in Aurora, Colorado, said: “I am excited to see novel technology from PARI Pharma put to work for CF patients. The fact that Altera will deliver this therapy in two to three minutes changes the paradigm of inhaled treatments by nebulizer. CF patients typically perform a variety of nebulizer treatments that take hours a day. This impacts their daily lives, so it is important to see that researchers are working to improve not only new drugs but also new delivery devices.”