After 30 years on the market, Flolan (epoprostenol) was discontinued in November 2025, marking the end of an era for pulmonary arterial hypertension treatment. Healthcare professionals worked throughout 2025 to transition patients to alternative therapies. Veletri, a room temperature-stable version of epoprostenol, remains available.
A recent article in the News section of the US Pulmonary Hypertension Association’s website describes the key milestones in the development of Flolan, here is a summary.
A Game-Changer in 1995
Before the Food and Drug Administration (FDA) approved Flolan in 1995, there was no targeted therapy for pulmonary arterial hypertension. Patients faced limited options: non-specific vasodilators and blood pressure medications that affected the entire body, or the extreme option of lung or heart-lung transplantation (first successful procedures in 1981 and 1986 respectively).
Flolan changed everything. Administered continuously through a chest catheter connected to a battery-powered pump, it specifically targeted lung arteries—relaxing narrowed blood vessels, increasing lung blood supply, and reducing heart workload. For the first time, pulmonary arterial hypertension patients had hope.
The Approval Journey
The Food and Drug Administration approval process was remarkable. Initial clinical trial results were so positive that its reviewers questioned their validity—during the 12-week trial, 20% of control group patients died while everyone receiving Flolan survived and most improved.
Patient testimony proved crucial. LuAnne Washburn, diagnosed in 1988 with six months to live, became “lucky patient 13” in the experimental trial starting in 1989. Her Food and Drug Administration testimony described returning to full-time work after starting Flolan. She remained on Flolan for 13 years, then stable on oral medications for another 13 years before transitioning to intravenous (IV) Remodulin—surviving 37 years since diagnosis.
The collaboration between the Pulmonary Hypertension Association (then United Patients Association for Pulmonary Hypertension), early pulmonary hypertension medical leaders including Dr. Lewis Rubin, patients like Washburn and board member Greg Elliott, and manufacturer Burroughs Wellcome (now GSK) helped persuade the Food and Drug Administration that the results were real.
Lasting Legacy
Since 1995, more than a dozen targeted pulmonary arterial hypertension therapies have been approved, targeting four different disease pathways. While Flolan is no longer available, the research behind it served as a crucial stepping stone for many current treatment options.
As Washburn reflects: “I’ve been incredibly fortunate to survive 37 years and witness the development of many new therapies that have helped so many others. I’ll never forget the day I testified before the FDA. It felt surreal to see a medication that had saved so many lives undergo such intense scrutiny. I truly believe Flolan saved mine.”
Key message: Flolan’s 30-year journey from revolutionary first treatment to discontinuation represents the remarkable progress in pulmonary arterial hypertension therapy—from no options to multiple targeted treatments, transforming a fatal diagnosis into a manageable chronic condition.