New COPD Treament Option, Seebri Neohaler, Now Available to U.S. Patients

New COPD Treament Option, Seebri Neohaler, Now Available to U.S. Patients

Seebri Neohaler, a long-term maintenance therapy for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), is now available at U.S. pharmacies.

“COPD is a serious, progressive respiratory disease that should have a personalized approach to choosing a therapy and delivery method,” Dr. Edward Kerwin, medical director of the Clinical Research Institute of Southern Oregon, said in a press release. “There remains a need for additional treatment options for newly diagnosed patients as well as those managing uncontrolled symptoms.”

Seebri Neohaler (glycopyrrolate) inhalation powder (15.6 mcg twice daily) was developed by Novartis, but Sunovion markets it in the United States.

“As a part of our commitment to millions of people living with COPD in the United States, Sunovion is pleased to introduce Seebri Neohaler as a new treatment option,” David Frawley, executive vice president and chief commercial officer at Sunovion, which is based in Marlborough, Massachusetts. “Seebri Neohaler, a handheld, dry powder inhaler, is an important part of Sunovion’s COPD portfolio that includes a broad range of medications and delivery methods that can address individual patient needs.”

Besides Seebri Neohaler, Sunovion retains exclusive market rights for two other COPD therapies approved by the U.S. Food and Drug Administration: Utibron Neohaler (indacaterol and glycopyrrolate) and Arcapta Neohaler (indacaterol). Novartis granted Sunovion commercialization rights for all three in December 2016.

Seebri Neohaler is a long-acting muscarinic antagonist (LAMA) that acts by relaxing and opening the respiratory airways, making it easier to breathe. LAMAs are widely used to treat COPD. Seebri Neohaler was developed to treat COPD, including chronic bronchitis and emphysema.

Two clinical studies (NCT01709864 and NCT01715298) using Seebri Neohaler showed statistically significant improvements in lung function versus placebo over a 12-week treatment period.

Researchers assessed lung function by measuring forced expiratory volume in one second and forced vital capacity (the amount of air a patient can forcibly exhale after taking the deepest breath possible) within five and 15 minutes after drug administration versus placebo.

The drug also showed improvements in health-related quality of life and less need for medicines for severe respiratory difficulty.

2 comments

  1. John Polachek says:

    What a joke! FDA makes jerks out of all of us, here in USA give us 15.6 mcg twice a day. The rest of the world gets 150 mcg to 300 mcg once a day. This is nothing more than FDA picking lossers and winners. Check the results of Ultibron Neohaler used in Europe against the rest of all drugs out here and it is far better, but FDA must be out to get them.

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