Magnair, an eFlow closed system nebulizer, together with Sunovion’s Lonhala is the first eFlow technology-based product to receive FDA approval to treat chronic obstructive pulmonary disease (COPD).
Pari Pharma GmbH, a company focused on the development and commercialization of advanced aerosol delivery systems based on eFlow technology, announced approval of its first eFlow closed system nebulizer Magnair together with Sunovion Pharmaceutical Inc.‘s Lonhala (glycopyrrolate) inhalation system.
The Lonhala Magnair drug/device combination product received FDA approval on December 5th, 2017 under a New Drug Application (NDA).
Magnair, designed, optimized, and developed by Pari Pharma, is intended only for use with the Lonhala (glycopyrrolate) inhalation vials in patients with COPD. Magnair is the first product to be commercialized using Pari’s eFlow closed system nebulizer technology, which does not have a traditional open medication reservoir in which patients manually transfer the liquid drug product from a vial.
Magnair has a proprietary blow-fill-seal ampule that is inserted into the cap of Magnair and pierced open once the cap of the Magnair handset is closed, without the need for a manual filling step. This feature is designed to reduce risk of spilling of the medication when the vial is emptied.
As with all eFlow technology nebulizers, Magnair allows the patient to breathe naturally without any special breathing technique. The patient inhales and exhales as they normally do at rest.
“So far, eFlow Technology nebulizers like Altera, Zirela, Tolero, or eRapid/eFlowRapid are available to patients suffering from the orphan indication of cystic fibrosis,” Dr. Martin Knoch, president of Pari Pharma, said. “With the approval of Lonhala Magnair for COPD, we are bringing a new advancement in nebulizers that are designed to be efficient, silent, and fast to people with COPD.”
Pari Pharma develops aerosol delivery devices optimized with drug products for nebulized treatments using proprietary technologies. The company is located near Munich, Germany with a significant presence in the United States.