After many years under patent protection, the generic medication Tadalafil will soon be available. What does this mean for patients? Hopefully generic Tadalafil will be much less expensive than Adcirca. We can look back at what happened with a similar medicine, Revatio, when it went generic as sildenafil. Pricing We don’t know precise pricing but we expect deep discounts … [Read more...]
Inhaled Nitric Oxide and PAH: Update
Bellerophon announced that their phase 3 clinical trial using portable nitric oxide in patients with PAH has been stopped. The trial was stopped early after an analysis of data gathered so far showed no evidence of efficacy (the inhaled medication was not effective). There did not appear to be a safety problem. This clinical trial was exciting as very low nitric oxide … [Read more...]
Entire Implantable System for Remodulin Approved by the FDA
It is finally here! The Food and Drug Administration approved Remodulin in its implantable delivery system for treatment of Pulmonary Arterial Hypertension. We have been providing updates on the 8-year study that investigated the use of an implanted pump to deliver Remodulin removing the need for external pumps and are excited to announce it is finally approved. The pump … [Read more...]
Inhaled Nitric Oxide For Pulmonary Arterial Hypertension
What is Nitric Oxide? Nitric oxide is a small molecule that is made by the cells lining the pulmonary arteries (vascular endothelium). It acts on the same blood vessels to promote blood vessel relaxation (vasodilation). Since the early 1980’s we have known that patients with Pulmonary Arterial Hypertension have reduced levels of nitric oxide. When nitric oxide is not present … [Read more...]
Acceleron Launches a Phase 2 Study of Sotatercept for PAH
All of our existing therapies for Pulmonary Arterial Hypertension act by vasodilation or relaxing blood vessels. The current medications fall into one of three basic classes: 1. PDE5 inhibitor a. Sildenafil (Revatio/Viagra) b. Tadalafil (Adcirca/Cialiis) c. Riociguat (Adempas—not truly a PDE5inhibitor but similar action) 2. ERA a. Ambrisentan (Letairis) b. … [Read more...]