According to a story from PR Newswire, the U.S. Food and Drug Administration had approved the New Drug Application for an innovative new delivery system for Remodulin, a therapy that is used for the treatment of pulmonary arterial hypertension. The announcement was made by United Therapeutics who were responsible for developing the new system, which is officially known as the Implantable System for Remodulin (ISR).
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension is a condition in which the blood pressure of the arteries within the lungs is abnormally high. This condition often appears gradually. The cause of the illness can vary; in some cases, it is unknown, but in others it can be linked to heritable genetic mutations. Exposure to certain drugs and toxins can also cause the condition, and it is also associated with several other illnesses. Symptoms of pulmonary arterial hypertension include rapid heartbeat, shortness of breath, swelling in the legs, poor appetite, fainting, lightheadedness, fatigue, palpitations, chest pain, and abdominal pain. Treatment may include several medications, surgical procedures, and lung transplantation. It can almost eliminate exercise tolerance, and without treatment, patients rarely survive longer than two or three years. However, survival rates have been rising. To learn more about pulmonary arterial hypertension, click here.
Remodulin and the ISR
Remodulin was first approved for treating pulmonary arterial hypertension in 2002, and in 2004 it was approved for administration via the intravenous route. This system posed some disadvantages as the delivery procedure was a time sink for patients. There was also some risk of sepsis because the intravenous delivery method relied on a central indwelling catheter.
The ISR offers a better and safer option because the delivery system is actually implanted entirely into the patient’s body. This system simply can be refilled with an injection periodically by caregivers, depending on the dose that the patient is currently using.
The ISR should result in a meaningful boost to quality of life for pulmonary arterial hypertension patients that are currently using Remodulin as part of their treatment regimen. Now these patients can receive treatment without having to disrupt their daily schedule and without the treat of sepsis or other infections looming over them.