DirectRx pharmacy distributing COPD therapy Ohtuvayre in US
Verona Pharma treatment recently cleared to treat adults
DirectRx, a specialty pharmacy for people with chronic health disorders, is now part of the exclusive U.S. pharmacy network distributing Ohtuvayre (ensifentrine), a newly approved therapy for chronic obstructive pulmonary disease (COPD).
The Verona Pharma therapy, with a list price of $2,950 for a monthly supply, was cleared by the U.S. Food and Drug Administration in June as an inhaled maintenance therapy for adults with COPD.
“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,” Amanda Berishaj, vice president of clinical services at DirectRx, said in a company press release. “With our expertise in COPD, we are excited to be partnering with Verona Pharma on the launch on their novel and innovative therapy.”
COPD is marked by a chronic inflammation of the lungs that causes the narrowing of airways and breathing difficulties.
Bronchodilators, which relax muscles in the lungs and widen the airways, are commonly used to manage COPD, as well as inhaled corticosteroids. While corticosteroids can reduce inflammation, their long-term use is associated with serious side effects.
First new kind of COPD therapy in years
Ohtuvayre is the first medication with a new mechanism of action to be approved for COPD in more than two decades. Delivered directly to the lungs with a standard jet nebulizer twice a day, it exerts both anti-inflammatory and airway-widening effects.
The active component of Ohtuvayre is ensifentrine, a nonsteroidal molecule that halts the activity of phosphodiesterase 3 and phosphodiesterase 4, two lung enzymes that contribute to airway inflammation and muscle contraction. Suppression of these is expected to widen the airways and lessen inflammation, while also promoting mucus clearance.
Ohtuvayre’s dual mechanism is designed to effectively improve lung function, ease symptoms, and reduce the risk of exacerbations (periods of sudden symptom worsening) in COPD patients, without the side effects associated with inhaled corticosteroids. It can be prescribed alone or as an add-on medication to other 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.”
The therapy’s approval was supported by data from two Phase 3 clinical trials, ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057), which enrolled more than 1,400 people with moderate or severe COPD.
Participants were randomly assigned to receive either Ohtuvayre or a placebo for about six months. The majority were also taking standard bronchodilators.
Results from both trials showed that lung function, assessed using the forced expiratory volume in one second (FEV1), showed significantly greater improvements in Ohtuvayre-treated patients than in those given a placebo after about three months. These differences persisted after six months. FEV1 assesses how much air someone can blow out in a single, forceful breath.
Lung exacerbations rates were significantly lower in the Ohtuvayre group versus the placebo group after six months. And all these benefits were seen across several patient subgroups.
While the therapy was generally well tolerated, it has been linked to a higher risk of psychiatric problems, so particular attention is required for patients with a history of mental illness.
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