Brand Name
Ohtuvayre
Generic Name
Ensifentrine
View Brand Information FDA approval date: June 26, 2024
Classification: Phosphodiesterase 3 Inhibitor
Form: Suspension
What is Ohtuvayre (Ensifentrine)?
OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease in adult patients. OHTUVAYRE is a phosphodiesterase 3 inhibitor and phosphodiesterase 4 inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease in adult patients.
Approved To Treat
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Related Clinical Trials
A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD
Summary: This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).
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Brand Information
Ohtuvayre (ensifentrine)
1INDICATIONS AND USAGE
OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
2DOSAGE 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.
3DOSAGE FORMS AND STRENGTHS
Inhalation suspension: 3 mg/2.5 mL (1.2 mg/mL) of sterile, yellow to pale yellow, aqueous suspension in low-density polyethylene unit-dose ampules.
4CONTRAINDICATIONS
OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.
5ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Paradoxical Bronchospasm
- Psychiatric Events Including Suicidality
5.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of OHTUVAYRE was based on the pooled safety population from two randomized, double-blind, placebo-controlled trials (ENHANCE-1 and ENHANCE-2) for 24 weeks, and a 48-week cohort that assessed safety in ENHANCE-1. In these trials, a total of 975 patients received 3 mg of OHTUVAYRE twice daily administered by oral inhalation using a standard jet nebulizer
Adverse reactions that occurred at an incidence greater than or equal to 1% in OHTUVAYRE and were more common than placebo in the pooled population are provided in Table 1.
The proportion of patients who discontinued treatment due to adverse reactions was 7.6% for the OHTUVAYRE-treated patients and 8.2% for placebo-treated patients.
6OVERDOSAGE
An overdosage of OHTUVAYRE may lead to signs and symptoms such as headache, tachycardia, and palpitations. Treatment of overdosage consists of temporary interruption of OHTUVAYRE along with appropriate symptomatic and/or supportive therapy.
7DESCRIPTION
OHTUVAYRE (ensifentrine) is a sterile, yellow to pale yellow aqueous inhalation suspension of ensifentrine for oral inhalation. Ensifentrine, the active component of OHTUVAYRE, is an inhibitor of phosphodiesterases 3 and 4 (PDE3 and PDE4). The chemical name for ensifentrine is
Ensifentrine has a molecular weight of 477.56 and its empirical formula is C
OHTUVAYRE is supplied as 2.5 mL of sterile ensifentrine (1.2 mg/mL) suspension packaged in a unit-dose low-density polyethylene ampule overwrapped in a sealed foil pouch. Each unit-dose ampule contains 3 mg ensifentrine suspended in a pH 6.7 aqueous solution containing dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 20, sodium chloride, sorbitan monolaurate and water for injection.
The ampule containing OHTUVAYRE should be shaken vigorously to ensure complete resuspension of the active ingredient immediately prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the nebulization system used, and compressor performance.
Using the PARI LC Sprint® jet nebulizer attached to a PARI Vios Pro® compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 933 micrograms (31% of label claim) at a mean flow rate of approximately 5 liters per minute. The mean nebulization time was approximately 7 minutes. The mass median aerodynamic diameter (MMAD) of the nebulized particles/droplets using the PARI LC Sprint® jet nebulizer attached to a PARI Vios Pro® compressor (flow rate approximately 15 L per minute, nebulization time approximately 10 minutes) is 5.82 microns (geometric standard deviation = 1.97) with a typical fine particle dose (mass of aerosolized drug < 5 microns) of approximately 614 micrograms, as determined using the Next Generation Impactor (NGI) method, based on USP <601>. OHTUVAYRE should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow and equipped with a mouthpiece.
8CLINICAL STUDIES
The efficacy of OHTUVAYRE was evaluated in two 24-week randomized, double-blind, placebo-controlled, parallel-group clinical trials (ENHANCE-1 [NCT04535986] and ENHANCE-2 [NCT04542057]). The two trials enrolled a total of 1553 adults with moderate to severe COPD.
ENHANCE-1 enrolled a total of 763 patients randomized 5:3 to receive 3 mg of OHTUVAYRE administered by oral inhalation via standard jet nebulizer such as PARI LC Sprint®
ENHANCE-2 enrolled a total of 790 patients randomized 5:3 to receive 3 mg of OHTUVAYRE twice daily administered by oral inhalation via a standard jet nebulizer such as PARI LC Sprint®
The primary endpoint for ENHANCE-1 and ENHANCE-2 was the change from baseline in FEV
In ENHANCE-1 and ENHANCE-2, serial spirometry was performed over 12 hours in all patients at baseline and Week 12. Serial spirometry data for ENHANCE-1 at Week 12 are shown in Figure 1.
Figure 1. Mean FEV
Trough FEV
9HOW SUPPLIED/STORAGE AND HANDLING
OHTUVAYRE (ensifentrine) 3 mg/2.5 mL inhalation suspension is a sterile aqueous suspension in a unit-dose low-density polyethylene ampule. OHTUVAYRE is supplied as:
- Carton of 60: 60 pouches of 1 unit-dose ampule (NDC 83034-003-60)
- Carton of 60: 12 pouches of 5 unit-dose ampules (NDC 83034-003-65)
Ampules are overwrapped in a sealed foil pouch. The ampule containing OHTUVAYRE should be shaken vigorously to ensure complete resuspension of the active ingredient immediately prior to use. The used ampule and any residual content should be discarded after use.
10PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
11PRINCIPAL DISPLAY PANEL - 3 mg/2.5 mL Ampule Carton
Ohtuvayre™
(ensifentrine)
3 mg/2.5 mL
FOR ORAL INHALATION ONLY
↑ STORE UPRIGHT
NDC: 83034-003-60
Rx Only
