RESEARCH TRIANGLE PARK, NC and SILVER SPRING, MD — May 23, 2002 —
United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Remodulin (treprostinil sodium) Injection as a continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise.
The FDA approved Remodulin under its accelerated approval regulations based on the largest double blind placebo-controlled study ever conducted in pulmonary arterial hypertension, a disease in which blood pressure in the pulmonary arteries rises to life-threatening levels.
In clinical trials, the most common side effects reported with Remodulin therapy included infusion site pain (85%) and infusion site reaction (83%). Other adverse events included headache (27%), diarrhea (25%), nausea (22%), rash (14%), jaw pain (13%), vasodilatation (11%), dizziness (9%), edema (9%), pruritus (itching) (8%) and hypotension (4%).
Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH. Approximately 500 pulmonary arterial hypertension patients worldwide continue to use Remodulin in open label studies sponsored by United Therapeutics, with some patients on the drug for nearly four years. Approximately 50,000 people in North America and Europe are estimated to be afflicted with NYHA Class II-IV forms of the disease, most of whom are undiagnosed.
e-Med Tools
קצר קולע וממוקד
e-Med סמינרים
אי-מד תחקירים
Medscape Tools
Journal Club
מרכזי מידע ושירות
Facebook
מידע למפרסם
מאגר תרופות
מאגר אנשי המקצוע
אינדקס שימושי
חדשות משה"ב
eMed HealthClub
מחקרים קליניים
השאירו תגובה
רוצה להצטרף לדיון?תרגישו חופשי לתרום!