CLINICAL TRIALS PROFILE FOR FLOLAN

All Clinical Trials for Flolan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004754 ↗	Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension	Completed	Baylor College of Medicine	Phase 4	1993-08-01	OBJECTIVES: I. Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion to patients with severe primary pulmonary hypertension for whom no alternative therapy is available. II. Obtain additional safety information on continuous infusion epoprostenol. III. Obtain additional information on economic resource health consumption.
NCT00004754 ↗	Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension	Completed	National Center for Research Resources (NCRR)	Phase 4	1993-08-01	OBJECTIVES: I. Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion to patients with severe primary pulmonary hypertension for whom no alternative therapy is available. II. Obtain additional safety information on continuous infusion epoprostenol. III. Obtain additional information on economic resource health consumption.
NCT00058929 ↗	A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension	Completed	United Therapeutics	Phase 4	2002-10-01	This trial is a study of Remodulin in patients with pulmonary arterial hypertension who have been transitioned from Flolan therapy. The study consists of Screening, Baseline and Treatment Phases. Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion criteria, patients will be assigned to study drug (Remodulin or placebo) and will enter the Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which patients will begin receiving subcutaneous study drug at a low dose determined by the patient's current dose of Flolan. The study drug dose will be increased gradually while the Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will continue until Flolan therapy has been discontinued and the patient is stable on study drug. Patients who are transitioned off Flolan, who are stable on study drug will be discharged from the clinic, and will continue to receive study drug on an outpatient basis. The patient will return to the clinic at Weeks 4 and 8 for assessments. Patients will remain on study drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be conducted and the patient will be dismissed from the study. Patients who successfully complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the investigator's discretion.
NCT00373360 ↗	Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin	Completed	United Therapeutics	Phase 4	2006-09-01	The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
NCT00439946 ↗	Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH	Terminated	United Therapeutics	Phase 4	2007-02-01	The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.
NCT00452218 ↗	Sorafenib Study: Dosing in Patients With Pulmonary Arterial Hypertension (PAH)	Completed	Bayer	Phase 1	2007-03-01	The purpose of this study is to assess the safety and tolerability of sorafenib in patients with PAH already on existing therapy with a prostacyclin [epoprostenol (Flolan)], treprostinil (Remodulin), or iloprost alone, or with or without sildenafil (Viagra/Revatio).

Clinical Trial Conditions for Flolan

Condition Name

Condition Name for Flolan
Intervention	Trials
Pulmonary Arterial Hypertension	6
Hypertension, Pulmonary	3
Cardiovascular Disease	2
Pulmonary Hypertension	2

Condition MeSH

Condition MeSH for Flolan
Intervention	Trials
Hypertension	10
Pulmonary Arterial Hypertension	9
Familial Primary Pulmonary Hypertension	8
Hypertension, Pulmonary	5

Clinical Trial Locations for Flolan

Trials by Country

Trials by Country for Flolan
Location	Trials
United States	31
Canada	4
Netherlands	3
France	1
Belgium	1

Trials by US State

Trials by US State for Flolan
Location	Trials
Texas	4
California	4
North Carolina	3
Ohio	3
Illinois	3

Clinical Trial Progress for Flolan

Clinical Trial Phase

Clinical Trial Phase for Flolan
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Flolan
Clinical Trial Phase	Trials
Completed	14
Terminated	2

Clinical Trial Sponsors for Flolan

Sponsor Name

Sponsor Name for Flolan
Sponsor	Trials
United Therapeutics	4
GlaxoSmithKline	3
Actelion	3

Sponsor Type

Sponsor Type for Flolan
Sponsor	Trials
Industry	11
Other	6
NIH	1

Clinical Trials, Market Analysis, and Projections for FLOLAN (Epoprostenol Sodium)

Introduction to FLOLAN (Epoprostenol Sodium)

FLOLAN, or epoprostenol sodium, is a prostacyclin vasodilator used primarily for the treatment of pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. Here, we will delve into the clinical trials, market analysis, and future projections for this critical medication.

Clinical Trials and Efficacy

Early Trials and Approval

FLOLAN was first approved by the FDA in 1995 for the treatment of PAH (WHO Group I) to improve exercise capacity. The initial clinical trials included predominantly patients with NYHA Functional Class III and IV symptoms, primarily those with idiopathic or heritable PAH, and PAH associated with scleroderma spectrum of diseases[4].

Key Findings

• These trials demonstrated that FLOLAN significantly improved exercise capacity, as measured by the 6-minute walk test. Patients treated with FLOLAN showed a marked improvement in symptoms and functional class compared to those receiving conventional therapy[4].
• The drug also reduced symptoms such as dyspnea, fatigue, and pain, and improved overall quality of life for patients with PAH.

Adverse Reactions and Safety

Clinical trials highlighted several adverse reactions associated with FLOLAN, including flushing, hypotension, tachycardia, nausea, vomiting, and diarrhea. The drug is a potent inhibitor of platelet aggregation, which increases the risk of bleeding complications, particularly in patients with other risk factors for bleeding[4].

Long-Term Use and Complications

Long-term use of FLOLAN involves chronic infusion through an indwelling central venous catheter, which can lead to local infections and pain. The rate of local infection was about 18%, and the rate for pain was about 11% during controlled trials. Sepsis was reported at a rate of 0.3 infections/patient per year in long-term follow-up[4].

Market Analysis

Global Market Trends

The global epoprostenol sodium drugs market is expected to grow at a significant CAGR over the forecast period, driven by several key factors:

• Increasing Geriatric Population: The growing number of elderly individuals, who are more prone to pulmonary hypertension, is a major driver. According to the World Health Organization, the global population aged 60 and older is expected to reach 2 billion by 2050[2].
• Rising Incidence of Hypertension: The increasing incidence and prevalence of hypertension worldwide also contribute to the market growth.
• Advancements in R&D: Continuous research and development in the pharmaceutical industry, particularly in the field of pulmonary hypertension treatments, are fueling the market[2].

Regional Insights

The market is divided into several regions, including North America, South America, Asia Pacific, Europe, Middle East, and Africa. Each region has its own growth rate and market share:

• North America and Europe: These regions are expected to maintain significant market shares due to advanced healthcare infrastructure and high adoption rates of new treatments.
• Asia Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and a large patient population[2].

Market Restraints

Despite the growth potential, the market faces several restraints:

• Side Effects: The drug's side effects, such as diarrhea, stomach pain, anxiety, headache, and dizziness, can hamper market growth.
• Complex Delivery System: The need for chronic infusion through a central venous catheter can lead to complications like infections and pain, which may deter some patients[2].

Future Projections

Market Growth Forecast

The global epoprostenol sodium drugs market is projected to continue its growth trajectory, reaching significant revenue by the end of the forecast period. The market is expected to benefit from increasing demand for effective treatments for pulmonary hypertension and the expanding geriatric population[2].

New Therapeutic Targets and Clinical Trials

Ongoing and future clinical trials are focusing on new therapeutic targets and combination therapies to enhance treatment outcomes for PAH patients. For example, studies are exploring the combination of bosentan and prostanoids, as well as other endothelin receptor antagonists and prostacyclin analogues, to improve efficacy and reduce side effects[1][3].

Technological Advancements

Advancements in drug delivery systems and technology are expected to improve the safety and efficacy of FLOLAN. For instance, developments in portable infusion pumps and catheter designs could reduce the risk of infections and other complications associated with long-term use[4].

Key Takeaways

• Clinical Efficacy: FLOLAN has been proven to significantly improve exercise capacity and symptoms in patients with PAH.
• Market Growth: The global epoprostenol sodium drugs market is expected to grow driven by the increasing geriatric population and advancements in R&D.
• Regional Variations: Different regions have varying growth rates and market shares, with North America and Europe leading the market.
• Future Directions: Ongoing clinical trials and technological advancements are aimed at improving treatment outcomes and reducing side effects.

FAQs

What is FLOLAN used for?

FLOLAN (epoprostenol sodium) is used for the treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and reduce symptoms.

What are the common side effects of FLOLAN?

Common side effects include flushing, hypotension, tachycardia, nausea, vomiting, diarrhea, and an increased risk of bleeding complications.

How is FLOLAN administered?

FLOLAN is administered through a chronic infusion using a small, portable infusion pump and an indwelling central venous catheter.

What are the market drivers for FLOLAN?

The market is driven by the growing geriatric population, increasing incidence of hypertension, and advancements in R&D.

What are the potential future developments in FLOLAN treatment?

Future developments include new therapeutic targets, combination therapies, and advancements in drug delivery systems to improve safety and efficacy.

Sources

1. The new clinical trials on pharmacological treatment in pulmonary ... - European Respiratory Journal[1]
2. Epoprostenol Sodium Drugs Market 2020 By Manufacturers ... - Stratagem Market Insights[2]
3. Clinical trial design and new therapies for pulmonary arterial ... - European Respiratory Journal[3]
4. FLOLAN (epoprostenol sodium) for injection - accessdata.fda.gov - FDA Label[4]
5. Net Present Value Model: Flolan - Market Research Reports ... - GlobalData[5]

Last updated: 2025-01-02