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more_legal_areas bosentanRemodulin is also used to treat pulmonary hypertension in the form of a synthetic, stable form of prostacyclin. This pulmonary hypertension treatment is a new treatment approved under accelerated approval regulations for advanced pulmonary hypertension. Manufactured by United Therapeutics, Remodulin was FDA approved on May 22, 2002 based on the largest double blind placebo-controlled study ever conducted in PAH. The president and CEO of United Therapeutics was "pleased that our constructive work with the FDA has resulted in the approval of Remodulin for all symptomatic stages of the disease, including the first approved therapy for NYHA Class II pulmonary arterial hypertension patients."
The approval of Remodulin was encouraging news for many patients and doctors due to the need for expanded treatment options for pulmonary hypertension patients. Remodulin was made immediately available through United Therapeutics U.S. distributors. The benefit of using Remodulin over already available Flolan is the longevity it remains within the body. Opposed to Flolan therapy, Remodulin''s dilation action lasts from 4-6 hours versus the 2-3 minute action of Flolan. In addition, Remodulin is administered under the skin called subcutaneous infusion, working with a MiniMed microinfusion device. The use of Remodulin carries a much lower risk of sepsis and other related hospitalizations that is associated to the use of Flolan because the elimination of the need for a catheter.
Side effects associated to the use of Remodulin include:
Although Remodulin still remains in Phase III trials, used for FDA approval to market a drug, Remodulin treatment has been well received amongst the pulmonary hypertension patients using the particular form of treatment.
Pulmonary arterial hypertension (PAH) is a rare disorder that strikes mostly women in the prime of their lives. The disorder elevates the blood pressure in the artery between the heart and lungs and usually proves to be fatally within three years of th...