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OHTUVAYRE® (ensifentrine) is a first-in-class approach to bronchodilation and non-corticosteroid anti-inflammation for COPD maintenance treatment in adults.1,2

Explore the data

Novel mechanism of action for a broad population1

OHTUVAYRE is a selective dual inhibitor of PDE3 and PDE4 and may fit into COPD maintenance treatment conversations, including persistently symptomatic patients and those on dual or triple therapy.

ENHANCE-1 and ENHANCE-2 did not include patients receiving LABA + LAMA or LABA + LAMA + ICS.1

Explore the MOA

Demonstrated efficacy

See Efficacy Data in the ENHANCE clinical trials.

See the study results

The Merck Access Program (MAP) for OHTUVAYRE

Verona Pathway Plus is transitioning to The Merck Access Program. Patients and providers may see both names during this time, but your support will remain uninterrupted.

The MAP for OHTUVAYRE may be able to help answer questions and provide information about:

  • Patient insurance coverage and out-of-pocket costs
  • Co-pay assistance for eligible, privately insured patients
  • How patients may access OHTUVAYRE through the Merck Specialty Pharmacy Network.
Explore support resources

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

Your symptomatic adult patients with COPD have unique needs and stories.

OHTUVAYRE may fit into COPD maintenance treatment conversations, including those with persistently symptomatic patients and those on dual or triple therapy.1

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Michael

Age 67

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Jackie

Age 65

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Eva

Age 66

Learn more about how OHTUVAYRE may help patients like them

See patient profiles

A selective dual inhibitor of PDE3 and PDE4 that may be added to current maintenance COPD therapy.1

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.