The FDA approved a nebulized formulation of glycopyrrolate (Lonhala Magnair) for long-term maintenance treatment of patients with moderate-to-severe COPD, said manufacturer Sunovion Pharmaceuticals. It’s the first long-acting muscarinic antagonist (LAMA) to be sold in this form.
Recommended dosing is 25 mcg twice daily.
The approval was made on the strength of data from two 12-week, randomized, multicenter trials in which the drug demonstrated improvements in forced expiratory volume in one second (FEV1) compared to placebo.
An additional 48-week safety trial compared the Sunovion product to inhaled tiotropium bromide (Spiriva HandiHaler). Results from that trial showed that the nebulized glycopyrrolate treatment was well tolerated over the treatment period and that treatment-related adverse events were comparable between the two drugs.
The FDA accepted Sunovion’s new drug application in October 2016, but it was initially rejected last May with no public explanation.
Pulmonary specialist James F. Donohue, MD, of the University of North Carolina in Chapel Hill, said the availability of a nebulized LAMA represents a significant advance in the treatment of COPD.
“Glycopyrrolate is a very effective agent,” he said. “We haven’t had a long-term anti muscarinic in nebulizer form, and that has been a defect.”
The FDA is currently considering approval of a second nebulized LAMA, Theravance Biopharma and Mylan’s drug revefenacin, which has been investigated as a once-daily COPD treatment.
Donohue presented positive phase III data on that drug last month in Toronto at the CHEST annual meeting, and he was also involved in the research for the Sunovion product.
“As a doctor, I’m really looking forward to having these agents available,” he said. “Many patients are sent home now with their nebulizer LABA [long-acting beta agonist] plus an inhaled corticosteroid. We need the LAMA component.”
Sunovion also highlighted the “virtually silent, portable, closed system nebulizer,” which it said delivers the drug over 2-3 minutes while patients breathe normally. The firm expects to have the new LAMA product on pharmacy shelves in early 2018.