Bayer developed a nebulizer to deliver iloprost as a mist, in collaboration with Vectura. It has been approved in Europe, but not the U.S. The launch of the handheld nebulizer, called Breelib, was in Poland in April 2017.
How Ventavis works
Iloprost, the active component of Ventavis, is a synthetic version of prostacyclin. Prostacyclin is a substance the body produces that causes blood vessels to widen, reducing resistance to blood flow.
Ventavis is an inhaled formulation of iloprost that is administered with a nebulizer. Because Ventavis is delivered directly to the lungs, it can do a better job of widening pulmonary arteries and reducing blood pressure. The increased blood flow that the therapy generates in the lungs leads to better oxygen transport around the body, improving patients’ ability to exercise.
Ventavis in clinical trials
Inhaled iloprost has been investigated as a PAH therapy in a wide range of clinical trials that started in 1988.
A key trial that supported its approval in the United States and European Union was the AIR (Aerosolized Iloprost Randomized) study. It covered 203 patients with severe PAH and chronic thromboembolic pulmonary hypertension, or CTEPH. Researchers randomized participants to receive either Ventavis or a placebo for 12 weeks.
The results, published in the New England Journal of Medicine, showed that significantly more patients responded to Ventavis than to a placebo. Researchers defined a response as at least a one-class improvement in patients’ New York Heart Association functional class score. This equated to at least a 10 percent improvement in the distance a patient was able to walk in six minutes or no worsening of their symptoms.
When the results were re-examined based on the type of pulmonary hypertension patients had, the investigators discovered there was no evidence that Ventavis improved CTEPH symptoms. Nineteen percent of the PAH patients responded to Ventavis, compared with only 4 percent of the placebo group.
A long-term Phase 2 trial called AIR-2 (NCT00414687) investigated the safety and effectiveness of Ventavis in 63 participants for up to two years. Results published in the journal Respiratory Medicine suggested that the treatment helped patients and that they tolerated it well. For example, patients who continued to receive Ventavis for the entire two-year period increased their six-minute walk distance by 34 percent.
Common side effects of Ventavis include headache, flushing, bleeding episodes, chest pain, swelling of the ankles and feet, nausea, jaw pain, and cough.
The European Union granted marketing authorization to Ventavis as a therapy for adults with PAH on Sept. 16, 2003. The FDA approved Ventavis in December 2004. The handheld nebulizer Breelib was approved by the European Union in December 2016.
Europe authorized an IV-administered formulation of iloprost known as Ilomedin as a treatment for peripheral vascular disease in 1990. Clinical trials assessed the intravenous formulation as a potential PAH therapy, but it was not approved because of insufficient evidence that it was safe and effective.
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