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A novel inhaled PDE3/4 inhibitor for COPD maintenance treatment in adults1,2

Help your patients reclaim their breath with Ohtuvayre, a novel approach to bronchodilation and non-steroidal anti-inflammation.1-9

Novel mechanism
of action

Selective dual inhibitor of PDE3 and PDE4 that gives you the flexibility to prescribe as monotherapy or as an add-on to current maintenance therapy1,2

Proven efficacy

Early and sustained improvements in lung function when studied across a broad population of patients with COPD1,2

Most common
adverse reactions

Adverse reactions with an incidence of ≥1% and greater than placebo included back pain, hypertension, urinary tract infection, and diarrhea1

Your symptomatic patients with COPD have unique needs and stories. 

Ohtuvayre can be used in multiple patient types, including those who are symptomatic on maintenance therapy1,2

Jackson

Maureen

Age 65

  • Dyspnea with exertion
  • Currently on combined bronchodilator/ICS therapy
  • FEV1: ~49%
  • Recent history of exacerbation requiring hospitalization
Jackson

Jackson

Age 66

  • Currently on nebulized treatment
  • FEV1: 53%
  • Symptoms are worsening and he recently required a round of antibiotics
  • Has type 2 diabetes
Jackson

Jane

Age 62

  • Concerned about ICS therapy
  • FEV1: 53%
  • Former smoker
  • Has chronic bronchitis
Dave

Dave

Age 57

  • Struggles with persistent dyspnea and has switched medications many times
  • FEV1: 45%
  • Is a former smoker
  • Has diabetes and coronary artery disease

Learn more about how Ohtuvayre may help patients like them

A different option for COPD management is here.

Explore Ohtuvayre and request a rep today.

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. 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 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.

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.

Adverse Reactions: The most common adverse reactions ≥1% in Ohtuvayre and greater than placebo in the pooled population were back pain 1.8%, hypertension 1.7%, urinary tract infection 1.3%, and diarrhea 1.0%.

These are not all of the possible risks associated with Ohtuvayre. Please see Full Prescribing Information for Ohtuvayre.

To report suspected adverse reactions, contact Verona Pharma, Inc. at
1-888-672-0371 or FDA at
1-800-FDA-1088 or
www.fda.gov/medwatch.

References:
1. Ohtuvayre™ (ensifentrine). Prescribing Information. Raleigh, NC: Verona Pharma plc; 2024. 2. 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. 3. Cazzola M, Hanania NA, Page CP, Matera MG. Novel anti-inflammatory approaches to COPD. Int J Chron Obstruct Pulmon Dis. 2023;18:1333-1352. 4. Singh D, Abbot-Banner K, Bengtsson T, Newman K. The short-term bronchodilator effects of the dual phosphodiesterase 3 and 4 inhibitor RPL554 in COPD. Eur Respir J. 2018;52:1801074. 5. Singh D, Martinez FJ, Watz H, Bengtsson H, Maurer BT. A dose-ranging study of the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD. Respir Res. 2020;21:47. 6. Ferguson GT, Kerwin EM, Rheault T, Bengtsson T, Rickard K. A dose-ranging study of the novel inhaled dual PDE 3 and 4 inhibitor ensifentrine in patients with COPD receiving maintenance tiotropium therapy. Int J Chron Obstruct Pulmon Dis. 2021;16:1137-1148. 7. Boswell-Smith V, Spina D, Oxford AW, Comer MB, Seeds EA, Page CP. The pharmacology of two novel long-acting phosphodiesterase 3/4 inhibitors, RPL554 [9,10-dimethoxy-2(2,4,6-trimethylphenylimino)-3-(N-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2H-pyrimido[6,1-a]isoquinolin-4-one] and RPL565 [6,7-dihydro-2-(2,6-diisopropylphenoxy)-9,10-dimethoxy-4H-pyrimido[6,1-a]isoquinolin-4-one]. J Pharmacol Exp Ther. 2006;318(2):840-848. 8. Rheault T, Macdonald-Berko M. Anti-inflammatory pharmacology of ensifentrine. Poster presented virtually at: CHEST Annual Meeting; October 18-21, 2020. 9. Franciosi LG, Diamont Z, Banner KH, et al. Efficacy and safety of RPL554, a dual PDE3 and PDE4 inhibitor, in healthy volunteers and in patients with asthma or chronic obstructive pulmonary disease: findings from four clinical trials. Lancet Respir Med. 2013;1(9):714-727.