Flolan (epoprostenol) was discontinued in November after 30 years on the market. Health care professionals worked throughout 2025 to help people taking the drug to transition to alternate therapies.

Veletri, a room temperature-stable version of epoprostenol, remains on the market.

Flolan was the first targeted therapy for pulmonary arterial hypertension. Before the Food and Drug Administration approved Flolan in 1995, there was no treatment specifically for PH. Physicians prescribed vasodilators, blood pressure medication and other drugs that worked on arteries throughout the whole body, rather than just in the lungs.

The only other option was more extreme. For a few patients, lung or heart-lung transplant offered a potential “cure.” However, the first successful heart-lung transplant for PH didn’t occur until 1981, and the first single lung transplant came later, in 1986. Although transplant eliminates pulmonary hypertension, it comes with its own life-long health complications.

Flolan presented a different kind of treatment option. Administered through a catheter placed surgically into a large vein in the chest, it targeted arteries in the lungs. It relaxed and dilated narrowed blood vessels, increased blood supply to the lungs and reduced the workload of the heart. A small battery-powered pump kept the medication flowing continuously into the body.

Physicians described it as a game-changer because it gave people with PAH hope for the first time.

Approval process

When the first drug for a rare disease is under development, it is common for patients, medical professionals and drug manufacturers to work together. The collaboration helps FDA understand the value of the new drug to patients and helps manufacturers understand what patients need most.

In 1995, the Pulmonary Hypertension Association (then called the United Patients Association for Pulmonary Hypertension) worked closely with early leaders in PH medicine, people with PH and drug manufacturer, Burroughs Wellcome (now GSK).

When FDA received initial scientific data about Flolan, FDA reviewers questioned the validity of the clinical trial because the results were so positive. During the 12-week clinical trial, 20% of patients in the control group died. Everyone who received Flolan survived and most improved.

PHA founder Judy Simpson wanted patients to testify before the FDA, but lead researchers initially resisted. Eventually, expert PH physicians and patients worked together to persuade FDA that the results were real, including early PHA board member Greg Elliott. LuAnne Washburn (pictured below), who was given six months to live when she was diagnosed in 1988, was one of two patients who testified.

“Fortunately, my Milwaukee cardiologist knew of an experimental study in Baltimore,” Washburn recalls. “I traveled there to see Dr. Lewis Rubin, though I was initially randomized out of the trial for six months.”

Washburn began Flolan treatment in 1989 during its experimental phase and became “lucky patient 13” in the trial. In her testimony before FDA, she shared how she could return to work full time after starting Flolan.

Washburn stayed on Flolan for 13 years and remained stable on oral medications for 13 years after weaning off the pump. When her health declined again, she began IV Remodulin (treprostinil), which she remains on today.

 

Moving forward

Since Flolan’s approval in 1995, more than a dozen targeted therapies for PH have become available. In that time, researchers have identified several PH pathways, or ways in which PH affects the body.

Today’s treatments target four of those pathways, and PH specialists often prescribe more than one PH medication for maximum impact.

Through all of those changes, Flolan remained an important treatment, especially for people with more advanced disease. While Flolan is no longer available as a PH treatment, the research behind it served as a stepping stone for several of the currently available therapy options.

“I’ve been incredibly fortunate to survive 37 years and witness the development of many new therapies that have helped so many others,” Washburn says. “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.”