DirectRx, a specialty pharmacy focused on chronic health disorders, has joined the exclusive U.S. pharmacy network for distributing Ohtuvayre (ensifentrine), a recently FDA-approved therapy for chronic obstructive pulmonary disease (COPD). This development marks a significant advancement in COPD treatment, offering a novel mechanism of action after more than two decades of limited innovation in the field.
The Verona Pharma therapy, priced at $2,950 for a monthly supply, gained FDA approval in June as an inhaled maintenance treatment for adult COPD patients. Ohtuvayre is administered via a standard jet nebulizer twice daily, delivering both anti-inflammatory and bronchodilatory effects directly to the lungs.
Novel Mechanism of Action
Ohtuvayre's active ingredient, ensifentrine, is a nonsteroidal molecule that inhibits phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4), two enzymes present in the lungs that contribute to airway inflammation and muscle contraction. By suppressing these enzymes, ensifentrine widens the airways, reduces inflammation, and promotes mucus clearance, distinguishing it from traditional bronchodilators and inhaled corticosteroids.
"We followed the clinical trials closely which found that Ohtuvayre demonstrated both early and sustained improvements in lung function across a broad population of patients with COPD," said Amanda Berishaj, vice president of clinical services at DirectRx. "With our expertise in COPD, we are excited to be partnering with Verona Pharma on the launch on their novel and innovative therapy."
Clinical Trial Data
The FDA's approval of Ohtuvayre was supported by data from the ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057) Phase 3 clinical trials, involving over 1,400 participants with moderate to severe COPD. Patients were randomized to receive either Ohtuvayre or a placebo over six months, with the majority also using standard bronchodilators.
Both trials demonstrated statistically significant improvements in lung function, as measured by forced expiratory volume in one second (FEV1), in the Ohtuvayre group compared to the placebo group after three months, with these improvements sustained at six months. Furthermore, exacerbation rates were significantly lower in the Ohtuvayre group. These benefits were observed across various patient subgroups.
Considerations
While Ohtuvayre was generally well-tolerated in clinical trials, it has been associated with a higher risk of psychiatric problems. Therefore, caution is advised when prescribing Ohtuvayre to patients with a history of mental illness. The medication can be prescribed as a standalone treatment or as an add-on to existing COPD therapies.
"We are honored to be selected as part of Ohtuvayre’s exclusive distribution network of accredited pharmacy partners," said Alban Ivezaj, president of DirectRx. "Thousands of prescribers across the United States trust DirectRx with their patients’ COPD medications — we are excited to be able to support these prescriber partners with Ohtuvayre."
