63 years was the mean age, with all patients aged ≥40 years
53% were current smokers (average smoking history of 52 pack-years)
~30% had background LABA use
19% had an exacerbation in the past 12 months
64% had high CV risk.† More information on safety and efficacy for background CV risk
*Both studies were conducted with LONHALA MAGNAIR 25 mcg, 50 mcg, or placebo twice daily. Information for the LONHALA MAGNAIR 25 mcg arm is displayed here (the 50 mcg dosage strength did not provide significant additional benefit and is not presented or approved for use). Baseline patient characteristics were similar across all arms of the studies.
†Any subject with a preexisting diagnosis of ischemic heart disease, cerebrovascular disease, peripheral arterial disease, hypertension, clinically significant arrhythmia, or heart failure.
CV=cardiovascular; LABA=long-acting beta2-agonist.
Pooled analysis of two 12-week trials
Adverse reactions with ≥2% incidence and higher than placebo1
48-week, long-term, open-label safety clinical trial1
BID=twice daily; COPD=chronic obstructive pulmonary disease.
Efficacy and safety were assessed in two 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trials in subjects with moderate to very severe COPD. Subjects were randomized using a 1:1:1 ratio to 1 of 3 treatments: placebo BID, LONHALA MAGNAIR 25 mcg BID, and glycopyrrolate 50 mcg BID. Safety end points included the number and percentage of subjects with treatment-emergent adverse events (TEAEs) and serious AEs, and the number and percentage of subjects who discountinued treatment due to TEAEs.2,3
1. LONHALA MAGNAIR (glycopyrrolate) Inhalation Solution [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.
2. Data on file. Integrated Summary of Safety. 156. Sunovion Pharmaceuticals Inc.
3. Kerwin E, Donohue JF, Goodin T, et al. Efficacy and safety of glycopyrrolate/eFlow® CS (nebulized glycopyrrolate) in moderate-to-severe COPD: results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trials. Respir Med. 2017;132:238–250.
4. Data on file. Glycopyrrolate Inhalation Solution Protocol SUN101-303 Clinical Study Report. NCT identifier: 0227622. Sunovion Pharmaceuticals Inc.
5. Data on file. Summary of Clinical Safety. Sunovion Pharmaceuticals Inc.
LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients.
LONHALA MAGNAIR should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
As with other inhaled medicines, LONHALA MAGNAIR can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs following dosing with LONHALA MAGNAIR, it should be treated immediately with an inhaled, short-acting bronchodilator; LONHALA MAGNAIR should be discontinued immediately and alternative therapy instituted.
Immediate hypersensitivity reactions have been reported with LONHALA MAGNAIR. If signs occur, discontinue LONHALA MAGNAIR immediately and institute alternative therapy.
LONHALA MAGNAIR should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any of these signs or symptoms develop.
The most common adverse events reported in ≥2% of patients taking LONHALA MAGNAIR, and occurring more frequently than in patients taking placebo, were dyspnea (4.9% vs 3.0%) and urinary tract infection (2.1% vs 1.4%).
LONHALA solution is for oral inhalation only and should not be injected or swallowed. LONHALA vials should only be administered with MAGNAIR.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
LONHALA® MAGNAIR® (glycopyrrolate) is an anticholinergic indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.