What is the recommended dosage and treatment guidelines for ensifentrine in patients with chronic obstructive pulmonary disease (COPD)?

Ensifentrine Dosage and Treatment Guidelines for COPD

The recommended dosage of ensifentrine (OHTUVAYRE) for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients is 3 mg (one ampule) twice daily administered by oral inhalation using a standard jet nebulizer with a mouthpiece. 1

Dosage Information

• Ensifentrine is supplied as a 3 mg/2.5 mL aqueous suspension in unit-dose ampules 1
• The medication should be administered twice daily via a standard jet nebulizer with a mouthpiece 1
• No dosage adjustment is specified for elderly patients in the available evidence 1
• Use with caution in patients with hepatic impairment as ensifentrine exposure increases in these patients 1

Mechanism of Action and Benefits

• Ensifentrine is a first-in-class selective dual inhibitor of phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) 2
• It provides both bronchodilator and non-steroidal anti-inflammatory effects in a single molecule 3
• Clinical trials have demonstrated significant improvements in lung function with ensifentrine treatment 4

Clinical Efficacy

• Ensifentrine significantly reduces the rate of moderate to severe COPD exacerbations (rate ratio 0.59; 95% CI, 0.43-0.80; P < .001) compared to placebo 2
• It increases time to first exacerbation (hazard ratio 0.59; 95% CI, 0.44-0.81; P < .001) 2
• Improvement in lung function is demonstrated by significant enhancement in average FEV1 area under the curve at 0-12 hours versus placebo (87-94 mL improvement) 4
• Symptom improvement is observed as early as Week 1, with greatest effects on breathlessness 5

Patient Selection and Considerations

• Indicated for adult patients with COPD requiring maintenance treatment 1
• Efficacy has been demonstrated across various patient subgroups, including those with different:
  • Age, sex, and race 2
  • Background maintenance medication use 2
  • COPD severity levels 2
  • Exacerbation history 2
• Ensifentrine provides additional bronchodilation when added to long-acting muscarinic antagonists (LAMAs) or long-acting β2-agonists (LABAs) 3

Safety Considerations and Warnings

• Contraindicated in patients with hypersensitivity to ensifentrine or any component of the product 1
• Should not be used to treat acute symptoms of bronchospasm 1
• Discontinue if paradoxical bronchospasm occurs and institute alternative therapy 1
• Monitor for psychiatric adverse reactions, including suicidality, especially in patients with a history of depression and/or suicidal thoughts or behavior 1
• Most common adverse reactions (≥1% and more common than placebo) include back pain, hypertension, urinary tract infection, and diarrhea 1

Place in Therapy

• Ensifentrine represents a novel therapeutic option for COPD patients, particularly those who continue to experience symptoms or exacerbations despite standard therapies 3
• It can provide additional benefit when added to existing COPD treatments such as LAMAs or LABAs 3
• The medication appears to be initially developed for maintenance treatment of COPD, though it may also have potential in treating acute exacerbations 6

Important Clinical Considerations

• Ensifentrine should be considered for patients who continue to have symptoms or exacerbations despite optimized bronchodilator therapy 3
• The medication has demonstrated efficacy in reducing exacerbation risk in addition to providing bronchodilation 2
• Less information is available on whether ensifentrine provides additional benefit when added to inhaled corticosteroid or "triple therapy" regimens 3