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Explore OHTUVAYRE® (ensifentrine) for adult patients with COPD

For patients experiencing persistent COPD symptoms, OHTUVAYRE is a novel non-steroidal therapy that reduces inflammation and increases bronchodilation through selective PDE3 and PDE4 inhibition.1,2

Do not use OHTUVAYRE to treat acute episodes of bronchospasm.

Background therapy in ENHANCE-1 and ENHANCE-2 did not include participants on LABA + LAMA or LABA + LAMA + ICS. The efficacy results may not translate to these patient populations.

Actor Portrayal

Michael, age 67

Michael is an electrician, but his COPD symptoms, including persistent dyspnea and chronic productive cough, have started slowing him down. He’s beginning to worry he won’t be able to manage the demands of his work much longer.1

Currently on LABA + LAMA + ICS

Post-bronchodilator FEV1 is 48% of predicted

Baseline eosinophil count is 120 cells/μL2

One exacerbation over the last 6 months

COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in one second; ICS, inhaled corticosteroids; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist.

Jackie, age 65

Jackie manages the front desk at a small dental office, but she’s concerned she won’t be able to fulfill her duties much longer. Lately, her COPD symptoms, including dyspnea and chronic productive cough, have kept her from being able to check-in patients or answer phone calls.1

Currently on LABA + LAMA therapy

Post-bronchodilator FEV1 is 51% of predicted

Baseline eosinophil count is 60 cells/μL2

History of recurrent pneumonia2

No exacerbations in the past year

Medicare Part B with Supplemental Plan

COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in one second; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist.

Actor Portrayal

Actor Portrayal

Eva, age 66

After retiring from her long-time role as an administrative assistant, Eva was hoping to spend more time in her garden. However, despite completing pulmonary rehabilitation, she continues to experience dyspnea, which limits even light tasks.1,2

Currently on LAMA + LABA therapy

Post-bronchodilator FEV1 is 45% of predicted2

No exacerbations in the past year

COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in one second; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist.

A first-in-class approach that may help improve lung function in adult patients with COPD.1,2

See the impact of OHTUVAYRE on lung function in clinical studies.

Go to clinical data & efficacy

Take a look at the safety profile of OHTUVAYRE.

Go to safety

COPD, chronic obstructive pulmonary disease; ENHANCE, Ensifentrine as a Novel inHAled Nebulized COPD thErapy; ICS, inhaled corticosteroids; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; MOA, mechanism of action; PDE3, phosphodiesterase 3; PDE4, phosphodiesterase 4.

References

  1. Anzueto A, Barjaktarevic IZ, Siler TM, et al. Ensifentrine, a novel phosphodiesterase 3 and 4 inhibitor for the treatment of chronic obstructive pulmonary disease: randomized, double-blind, placebo-controlled, multicenter phase III trials (the ENHANCE trials). Am J Respir Crit Care Med. 2023;208(4):406-416. doi:10.1164/rccm.202306-0944OC
  2. Sciurba FC, Christenson SA, Rheault T, Bengtsson T, Rickard K, Barjaktarevic IZ. Effect of dual phosphodiesterase 3 and 4 inhibitor ensifentrine on exacerbation rate and risk in patients with moderate to severe COPD. Chest. 2025;167(2):425-435. doi:10.1016/j.chest.2024.07.168

INDICATION

OHTUVAYRE® (ensifentrine) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

SELECT SAFETY INFORMATION

CONTRAINDICATIONS

OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.

WARNINGS AND PRECAUTIONS

Acute Episodes of Bronchospasm
OHTUVAYRE should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. OHTUVAYRE has not been studied in the relief of acute symptoms and extra doses of OHTUVAYRE should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting bronchodilator.

 

Paradoxical Bronchospasm
As with other inhaled medicines, OHTUVAYRE may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with OHTUVAYRE, it should be treated immediately with an inhaled, short-acting bronchodilator. OHTUVAYRE should be discontinued immediately and alternative therapy should be instituted.

 

Psychiatric Events Including Suicidality
Treatment with OHTUVAYRE is associated with an increase in psychiatric adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received OHTUVAYRE (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week safety population were insomnia (6 patients [0.6%] OHTUVAYRE 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] OHTUVAYRE 3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed mood occurred in 4 patients (0.4%) receiving OHTUVAYRE and no patients receiving placebo.

 

Before initiating treatment with OHTUVAYRE, healthcare providers should carefully weigh the risk and benefits of treatment with OHTUVAYRE in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with OHTUVAYRE if such events occur.

ADVERSE REACTIONS

The most common adverse reactions ≥1% in OHTUVAYRE and greater than placebo in the pooled population in the ENHANCE-1 and ENHANCE-2 clinical trials were back pain (1.8% vs 1.0%), hypertension (1.7% vs 0.9%), urinary tract infection (1.3% vs 1.0%), and diarrhea (1.0% vs 0.7%).

 

These are not all of the possible risks associated with OHTUVAYRE.

DOSAGE AND ADMINISTRATION

The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the morning and once in the evening, administered by oral inhalation using a standard jet nebulizer with a mouthpiece.

SPECIAL POPULATIONS

Pediatric Use
The safety and effectiveness of OHTUVAYRE have not been established in pediatric patients.

 

Lactation
There are no data on the presence of ensifentrine in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OHTUVAYRE and any potential adverse effects on the breastfed child from OHTUVAYRE or from the underlying maternal condition.

 

Geriatric Use
In clinical trials, patients aged 65 and older showed no overall differences in the safety or effectiveness of OHTUVAYRE compared with younger adults, but greater sensitivity in some older individuals cannot be ruled out.

 

Hepatic Impairment
Ensifentrine systemic exposure increased by 2.3-fold in subjects with moderate or severe hepatic impairment compared with healthy subjects. Use OHTUVAYRE with caution in patients with hepatic impairment.

 

Before prescribing OHTUVAYRE® (ensifentrine), please read the accompanying Prescribing Information. The Patient Information and Instructions for Use also are available.

 

INDICATION
SELECT SAFETY INFORMATION

OHTUVAYRE® (ensifentrine) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

SELECT SAFETY INFORMATION

CONTRAINDICATIONS

OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.

WARNINGS AND PRECAUTIONS

Acute Episodes of Bronchospasm
OHTUVAYRE should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. OHTUVAYRE has not been studied in the relief of acute symptoms and extra doses of OHTUVAYRE should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting bronchodilator.

 

Paradoxical Bronchospasm
As with other inhaled medicines, OHTUVAYRE may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with OHTUVAYRE, it should be treated immediately with an inhaled, short-acting bronchodilator. OHTUVAYRE should be discontinued immediately and alternative therapy should be instituted.

 

Psychiatric Events Including Suicidality
Treatment with OHTUVAYRE is associated with an increase in psychiatric adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received OHTUVAYRE (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week safety population were insomnia (6 patients [0.6%] OHTUVAYRE 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] OHTUVAYRE 3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed mood occurred in 4 patients (0.4%) receiving OHTUVAYRE and no patients receiving placebo.

 

Before initiating treatment with OHTUVAYRE, healthcare providers should carefully weigh the risk and benefits of treatment with OHTUVAYRE in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with OHTUVAYRE if such events occur.

ADVERSE REACTIONS

The most common adverse reactions ≥1% in OHTUVAYRE and greater than placebo in the pooled population in the ENHANCE-1 and ENHANCE-2 clinical trials were back pain (1.8% vs 1.0%), hypertension (1.7% vs 0.9%), urinary tract infection (1.3% vs 1.0%), and diarrhea (1.0% vs 0.7%).

 

These are not all of the possible risks associated with OHTUVAYRE.

DOSAGE AND ADMINISTRATION

The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the morning and once in the evening, administered by oral inhalation using a standard jet nebulizer with a mouthpiece.

SPECIAL POPULATIONS

Pediatric Use
The safety and effectiveness of OHTUVAYRE have not been established in pediatric patients.

 

Lactation
There are no data on the presence of ensifentrine in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OHTUVAYRE and any potential adverse effects on the breastfed child from OHTUVAYRE or from the underlying maternal condition.

 

Geriatric Use
In clinical trials, patients aged 65 and older showed no overall differences in the safety or effectiveness of OHTUVAYRE compared with younger adults, but greater sensitivity in some older individuals cannot be ruled out.

 

Hepatic Impairment
Ensifentrine systemic exposure increased by 2.3-fold in subjects with moderate or severe hepatic impairment compared with healthy subjects. Use OHTUVAYRE with caution in patients with hepatic impairment.

 

Before prescribing OHTUVAYRE® (ensifentrine), please read the accompanying Prescribing Information. The Patient Information and Instructions for Use also are available.