Drug updated on 9/4/2024
Dosage Form | Oral (inhalation; 3 mg/2.5 mL) |
Drug Class | Phosphodiesterase 3 (PDE3) inhibitors and Phosphodiesterase 4 (PDE4) inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
Latest News
![loading GIF](/img/news-loading.gif)
Summary
- Ohtuvayre (ensifentrine) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
- This summary is based on the review of one randomized controlled trial(s). [1]
- Ensifentrine significantly improved lung function (FEV1 area under the curve at 0-12 hours) compared to placebo in both ENHANCE-1 and ENHANCE-2 trials: ENHANCE-1: 87 ml (95% CI, 55 to 119; \(P < 0.001\)); ENHANCE-2: 94 ml (95% CI, 65 to 124; \(P < 0.001\)).
- In the ENHANCE-1 trial, ensifentrine showed significant improvements in symptoms and quality of life at Week 24, while the ENHANCE-2 trial did not demonstrate significant improvements in these outcomes.
- Ensifentrine reduced the rate and time to first exacerbation in both trials: Rate reduction (ENHANCE-1: rate ratio 0.64, 95% CI, 0.40 to 1.00; \(P = 0.050\)); (ENHANCE-2: rate ratio 0.57, 95% CI, 0.38 to 0.87; \(P = 0.009\)); Time to first exacerbation (ENHANCE-1: hazard ratio 0.62, 95% CI, 0.39 to 0.97; \(P = 0.038\)); (ENHANCE-2: hazard ratio 0.58, 95% CI, 0.38 to 0.87; \(P = 0.009\)).
- The rate of adverse events was similar between ensifentrine and placebo groups in the studies.
- No specific adverse effects or safety concerns were highlighted in the provided studies.
- Patients aged 40-80 years with moderate to severe symptomatic COPD, many of whom were also receiving long-acting muscarinic antagonists (69%) or long-acting β2-agonists (55%), were included in the studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Ohtuvayre (ensifentrine) Prescribing Information. | 2024 | Verona Pharma, Inc., Raleigh, NC |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
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). | 1,549Subjects F: 47% M: 53% | 2023 | American Journal of Respiratory and Critical Care Medicine |
Sex Distribution:
F:47%
M:53%
1549Subjects
Year:
2023
Source:American Journal of Respiratory and Critical Care Medicine