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Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

On June 27, 2024, the U.S. Food and Drug Administration (FDA) approved Ohtuvayre (ensifentrine – Verona Pharma). It’s an inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4) for managing chronic obstructive pulmonary disease (COPD) in adults. The recommended dose is 3mg (one ampule) inhaled using a standard jet nebulizer twice daily. According to Verona Pharma, Ohtuvayre will launch during the third quarter of 2024 through a network of accredited specialty pharmacies. Pricing has not yet been announced. Look here for its complete prescribing information.

At a Glance

  • Brand Drug: Ohtuvayre(ensifentrine)
  • Manufacturer: Verona Pharma
  • Date Approved: June 27, 2024
  • Indication: for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients
  • Dosage Forms Available: single-dose ampules containing 3mg/2.5mL aqueous suspension for nebulization
  • Launch Date: Third quarter 2024
  • Estimated Annual Cost: Pricing information is not yet available.
  • COPD is characterized by the obstruction of airflow that leads to difficulty breathing; it is mainly caused by smoking cigarettes. More than 16 million Americans have COPD, and more than half of them are treated chronically. It is the third most common cause of death in the United States.
  • In COPD, maintenance treatment often includes a combination of inhaled corticosteroids, long-acting beta-2 agonists (LABAs), and long-acting muscarinic antagonists (LAMAs).
  • Ohtuvayre inhibits both the PDE3 and PDE4 enzymes, causing relaxation of the lung muscles and widening of the airways (bronchodilation) while also having anti-inflammatory effects.
  • In its trials, treatment with Ohtuvayre showed improved lung function and reduced the rate of COPD exacerbations when used alone or combined with other maintenance therapies for COPD.
  • The use of Ohtuvayre has been linked to an increased risk of psychiatric events, including suicidal thoughts. Healthcare providers should carefully assess patients with a history of depression or suicidal ideation before prescribing this medication.
  • Ohtuvayre should not be used as a rescue medication for acute bronchospasms.