Ensifentrine

(Ohtuvayre®)

Ensifentrine

Drug updated on 7/3/2024

Dosage FormOral (inhalation; 3 mg/2.5 mL)
Drug ClassPhosphodiesterase 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.

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Summary
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  • Ensifentrine (Ohtuvayre) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients, showing significant improvement in lung function and reduction in exacerbation risk.
  • The information was derived from randomized controlled trials.
  • In terms of efficacy and effectiveness, Ensifentrine demonstrated a statistically significant improvement in lung function as measured by FEV1 area under the curve at 0-12 hours versus placebo. It also resulted in improvements to symptoms and quality of life at Week 24 during the ENHANCE-1 study, but these findings were not replicated during the ENHANCE-2 study.
  • Safety profile analysis revealed that adverse event rates for Ensifentrine were similar to those for placebo, indicating a favorable safety profile.
  • The trials included participants aged between 40 to 80 years with moderate to severe symptomatic COPD; many patients were receiving concomitant long-acting muscarinic antagonists or long-acting β2 agonists, suggesting its utility across a wide spectrum within the COPD population both as a standalone treatment and part of combination therapy.
  • In comparison with other drugs used for treating COPD, no direct comparative studies are mentioned; hence, an accurate comparison cannot be drawn; however, given its positive outcomes, especially when combined with other therapies, it could potentially be a valuable addition, particularly among inadequately controlled cases.

Product Monograph / Prescribing Information

Document TitleYearSource
Ohtuvayre (ensifentrine) Prescribing Information.2024Verona Pharma, Inc., Raleigh, NC

Randomized Controlled Trials