2024 Approvals

Ohtuvayre: A New Maintenance Treatment for COPD Approved on June 26, 2024

Jasmine C

22 Aug 2025 — 1 min read

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What is it prescribed for?

Ohtuvayre is indicated for the maintenance treatment of chronic obstructive pulmonary disease.

What is the name of the drug and what does it do?

Ohtuvayre (pronounced OH-too-vare), (generic name: ensifentrine), is a medication indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It helps manage symptoms and reduce the frequency of flare-ups associated with COPD.

How does it work?

Ohtuvayre is a dual inhibitor of phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4).

These enzymes play a role in the regulation of muscle relaxation and inflammation in the airways. By inhibiting both PDE3 and PDE4, Ohtuvayre helps relax the muscles around the airways and reduce inflammation, making it easier to breathe and reducing COPD symptoms.

What did the research discover?

Clinical trials, such as the ENHANCE-1 and ENHANCE-2 studies, have shown that Ohtuvayre significantly improves lung function, as measured by forced expiratory volume in one second (FEV1).

Patients treated with Ohtuvayre experienced better airflow and reduced symptoms compared to those given a placebo.

Additionally, Ohtuvayre demonstrated a statistically significant improvement in health-related quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ).

What are some of the side effects?

Back pain
Hypertension (high blood pressure)
Urinary tract infection
Diarrhea

What are the dosage recommendations and how is it prescribed?

Ohtuvayre is prescribed as an inhalation suspension, with the recommended dosage being 3 mg (one ampule) taken twice daily using a standard jet nebulizer with a mouthpiece.

Patients should follow specific administration instructions provided by their healthcare provider to ensure proper use and effectiveness of the medication.

Source:

Verona Pharma, Inc. Ohtuvayre (ensifentrine) inhalation suspension, for oral inhalation use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217389s000lbl.pdf

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