MAXIMIZE
BRONCHODILATION...^1,2*

Primary endpoint: 150-mL increase from baseline in predose FEV₁ at Week 24 vs placebo (P<0.0001) in Trial 1^1,2†

BEVESPI AEROSPHERE is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

*Improvements in lung function, including predose FEV₁^† and peak FEV₁,^‡ relative to its individual components and placebo in two 24-week pivotal trials

Primary endpoint: Change from baseline in morning predose FEV₁ at Week 24^1,2

Secondary endpoint: Mean change from baseline in peak FEV₁ within 2 hours post-dose at Week 24^1,2

Secondary endpoint: Time to onset of action on Day 1^1,2

In separate Phase IIIb Trials: Through the breathing cycle^3,4

Chart showing 150 mL increase in predose FEV1 vs placebo at Week 24

Graph displaying the mean change from baseline in peak FEV1 within 2 hours post-dose at Week 24

Graph showing 291 mL increase in peak FEV1 vs placebo at Week 24

All study treatments administered BID.

There was also an increase from baseline in predose FEV₁ at Week 24 for BEVESPI AEROSPHERE vs glycopyrrolate 18 mcg (59 mL) and formoterol fumarate 9.6 mcg (64 mL) (both P<0.0001).^1,2 Statistically significant improvement in morning predose FEV₁ was also demonstrated in Trial 2^1,2
Adverse reactions with BEVESPI AEROSPHERE with a ≥2% incidence and more common than placebo were urinary tract infection and cough^1†
*Improvements in lung function relative to its individual components and placebo in two 24-week pivotal trials.

All study treatments administered BID.

Secondary endpoint: In Trial 1, there were significant improvements from baseline at Week 24 in peak FEV₁ for BEVESPI AEROSPHERE vs glycopyrrolate 18 mcg BID, formoterol fumarate 9.6 mcg BID, and placebo (P<0.0001 for all).^1,2 Statistically significant improvement in peak FEV₁ was also demonstrated in Trial 2^1,2^‡
Adverse reactions with BEVESPI AEROSPHERE with a ≥2% incidence and more common than placebo were urinary tract infection and cough¹
*Improvements in lung function relative to its individual components and placebo in two 24-week pivotal trials.

All study treatments administered BID.

In Trial 1, the mean increase in FEV₁ at 5 minutes after the first dose vs placebo (n=172) was 187 mL for BEVESPI AEROSPHERE (n=418), 44 mL for glycopyrrolate 18 mcg (n=363), and 184 mL for formoterol fumarate 9.6 mcg (n=366). The mean increase in FEV₁ at 120 minutes after the first dose vs placebo (n=218) was 260 mL for BEVESPI AEROSPHERE (n=523), 136 mL for glycopyrrolate 18 mcg (n=448), and 229 mL for formoterol fumarate 9.6 mcg (n=441) (P<0.0001 for all)^1,2
Statistically significant improvement in FEV₁ at 5 minutes was also demonstrated in Trial 2^1,2‡
Adverse reactions with BEVESPI AEROSPHERE with a ≥2% incidence and more common than placebo were urinary tract infection and cough¹
^*Improvements in lung function relative to its individual components and placebo in two 24-week pivotal trials.^1,2

Through the breathing cycle, from expiration through inspiration.

In Study A BEVESPI AEROSPHERE helped patients get nearly 20^% MORE AIR into their lungs⁵

BEVESPI AEROSPHERE is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

FROM EXPIRATION…

Achieved ~300 mL improvement in peak FEV₁ vs placebo³

Two separate Phase IIIb clinical trials evaluated the efficacy and safety of BEVESPI compared with placebo (Study A, n=35; Study B, n=75)³

Primary endpoint: Mean improvements in FEV₁ AUC_0-24 on Day 29 for BEVESPI vs placebo were 249 mL and 265 mL (for Study A and Study B, respectively; both P<0.0001)^4§
Secondary endpoint: Mean changes from baseline in peak FEV₁ on Day 29 (evening) for BEVESPI vs placebo were 293 mL and 337 mL (for Study A and Study B, respectively; P<0.0001)³

…THROUGH INSPIRATION

Achieved a 381 mL improvement in peak inspiratory capacity vs placebo³

Secondary endpoint (continued): Mean improvements in peak IC from baseline on Day 29 (evening) for BEVESPI vs placebo were 381 mL (19.4%) and 312 mL (16.5%) (for Study A and Study B, respectively; both P<0.0001)^4,5||¶
Adverse events were numerically similar across treatment arms³

All study treatments were administered BID.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: Long-acting beta₂-adrenergic agonists (LABAs), such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including formoterol fumarate.

The safety and efficacy of BEVESPI AEROSPHERE in patients with asthma have not been established. BEVESPI AEROSPHERE is not indicated for the treatment of asthma.

WARNINGS AND PRECAUTIONS

BEVESPI should not be initiated in patients with acutely deteriorating chronic obstructive pulmonary disease (COPD), which may be a life-threatening condition

BEVESPI should not be used for the relief of acute symptoms (ie, as rescue therapy for the treatment of acute episodes of bronchospasm). Acute symptoms should be treated with an inhaled short-acting beta₂-agonist

BEVESPI should not be used more often or at higher doses than recommended, or with other LABAs, as an overdose may result

If paradoxical bronchospasm occurs, discontinue BEVESPI immediately and institute alternative therapy

If immediate hypersensitivity reactions occur, in particular, angioedema, urticaria, or skin rash, discontinue BEVESPI at once and consider alternative treatment

BEVESPI can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, blood pressure, or symptoms. If such effects occur, BEVESPI may need to be discontinued

Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines

Be alert to hypokalemia and hyperglycemia

Worsening of narrow-angle glaucoma or urinary retention may occur. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction, and instruct patients to contact a physician immediately if symptoms occur

DRUG INTERACTIONS

Use caution if administering additional adrenergic drugs because the sympathetic effects of formoterol may be potentiated

Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of formoterol

Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta₂-agonists

The action of adrenergic agonists on the cardiovascular system may be potentiated by monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. Therefore, BEVESPI should be used with extreme caution in patients being treated with these agents

Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD

Avoid co-administration of BEVESPI with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects

MAXIMIZE
BRONCHODILATION...^1,2*

FROM EXPIRATION…

Achieved ~300 mL improvement in peak FEV₁ vs placebo³

…THROUGH INSPIRATION

Achieved a 381 mL improvement in peak inspiratory capacity vs placebo³

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

INDICATION

LIMITATION OF USE

MAXIMIZE BRONCHODILATION...1,2*

FROM EXPIRATION…

Achieved ~300 mL improvement in peak FEV1 vs placebo3

…THROUGH INSPIRATION

Achieved a 381 mL improvement in peak inspiratory capacity vs placebo3

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

INDICATION

LIMITATION OF USE

MAXIMIZE
BRONCHODILATION...^1,2*

Achieved ~300 mL improvement in peak FEV₁ vs placebo³

Achieved a 381 mL improvement in peak inspiratory capacity vs placebo³