SEEBRI™ NEOHALER®(glycopyrrolate) inhalation powder
About Seebri®/NVA237
Once-daily Seebri® (NVA237) (glycopyrronium bromide; Seebri® Breezhaler® (EU), Seebri® Inhalation Capsules 50mcg (Japan)) is an inhaled long-acting muscarinic antagonist (LAMA) that has already been approved in the EU and Japan as a maintenance bronchodilator treatment for COPD.
In the US, NVA237 was approved in October 2015 as a twice daily inhaled monotherapy for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema under the brand name Seebri™ Neohaler® (glycopyrrolate 15.6 mcg).
SEEBRI NEOHALER Rx
Pharmacological Class:
Long-acting anticholinergic.
Active Ingredient(s):
Glycopyrrolate 15.6mcg; per capsule; dry powder for oral inhalation for use with Neohaler device; contains lactose.
Company
Novartis Pharmaceuticals Corp
Indication(s):
Long-term maintenance treatment of airflow obstruction due to chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pharmacology:
Glycopyrrolate is a long-acting muscarinic antagonist (anticholinergic) with similar affinity to muscarinic receptor subtypes M1-M5.
In the airways, glycopyrrolate exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. Following inhalation of glycopyrrolate, the bronchodilation is predominantly a site-specific effect.
Clinical Trials:
The safety and efficacy of Seebri Neohaler were eva luated in two dose-ranging trials, four 12-week efficacy and safety trials, and a 52-week long-term safety trial.
The dose-ranging trial was a 28-day, randomized, double-blind, placebo-controlled, 2-period, crossover study that supported the dose selection of glycopyrrolate in chronic obstructive pulmonary disease (COPD). Seven doses of glycopyrrolate (15.6mcg, 31.2mcg, 62.4mcg, 124.8mcg once-daily and 15.6mcg, 31.2mcg, 62.4mcg twice-daily) were eva luated compared to placebo in 388 subjects with COPD. The differences in trough FEV1 from baseline after 28 days for glycopyrrolate 15.6mcg, 31.2mcg, 62.4mcg, 124.8mcg once-daily and 15.6mcg, 31.2mcg, 62.4mcg twice-daily vs. placebo were 0.083L (95% CI: 0.030, 0.136), 0.098L (0.048, 0.148), 0.090L (0.038, 0.142), 0.176L (0.132, 0.220), 0.139L (0.089, 0.189), 0.167L (0.115, 0.219), and 0.177L (0.132, 0.222), respectively. These results supported the eva luation of the glycopyrrolate 15.6mcg twice daily dose in the confirmatory COPD trials.
The confirmatory trials included two (Trials 1 and 2) similar 12-week, randomized, double-blind, placebo-controlled, parallel-group studies that eva luated glycopyrrolate 15.6mcg twice daily and placebo twice daily in 867 subjects with COPD.
The primary endpoint was the change from baseline in FEV1 AUC0–12h after the morning dose at Day 85 compared with placebo. In both trials, Seebri Neohaler demonstrated a larger increase in mean change from baseline in FEV1 AUC0–12h vs. placebo, with a treatment difference of 0.139L (95% CI: 0.095, 0.184) in Trial 1 and 0.123L (95% CI: 0.081, 0.165) in Trial 2. Both trials also showed that patients treated with Seebri Neohaler used less daily rescue albuterol during the trial compared to placebo patients.
For more clinical trial data, see full labeling.
Legal Classification:
Rx
Adults:
For oral inhalation use only with Neohaler device; do not swallow caps. Administer at the same time of the day (AM + PM). Inhale contents of one capsule (15.6mcg) twice daily.
Children:
Not established.
Warnings/Precautions:
Do not initiate in patients during acutely deteriorating or potentially life-threatening COPD episodes. Not for treating acute symptoms. Do not exceed recommended dose. Discontinue immediately and treat if paradoxical bronchospasm or immediate hypersensitivity reactions occur; use alternative therapy. Severe milk protein hypersensitivity. Narrow-angle glaucoma. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Severe renal impairment, including ESRD requiring dialysis. Pregnancy (Category C). Nursing mothers: not recommended.
Interaction(s)
Additive effects with concomitant other anticholinergic-containing drugs; avoid.
Adverse Reaction(s)
Upper respiratory tract infection, nasopharyngitis, urinary tract infection, sinusitis, oropharyngeal pain; paradoxical bronchospasm, hypersensitivity reactions.
How Supplied:
Blister pack—60 (w. one Neohaler device)
LAST UPDATED:
3/23/2016
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8839674f-26d6-4302-9da0-258decfba9aa
