CLINICAL TRIALS PROFILE FOR TAMBOCOR

All Clinical Trials for Tambocor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00392106 ↗	High Intensity Focused Ultrasound (HIFU) Ablation System Study	Suspended	ProRhythm, Inc.	Phase 3	2006-04-01	The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.
NCT00523978 ↗	A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation	Completed	Medtronic	Phase 3	2006-10-01	This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.
NCT00523978 ↗	A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation	Completed	Medtronic Atrial Fibrillation Solutions	Phase 3	2006-10-01	This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.
NCT00523978 ↗	A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation	Completed	Medtronic Cardiac Rhythm and Heart Failure	Phase 3	2006-10-01	This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.
NCT01833455 ↗	Premature Ventricular Contractions (PVCs) and Blood Pressure Control	Terminated	University of Wisconsin, Madison	Phase 2	2013-02-01	The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC suppression in a randomized, double-blinded, crossover fashion.
NCT02110537 ↗	Acupuncture in Persistent Atrial Fibrillation	Unknown status	Ministry of Health & Welfare, Korea	N/A	2014-03-01	The aim of this trial is to evaluate the effect of acupuncture on prevention of atrial fibrillation (AF) recurrence after electrical cardioversion (EC) for persistent AF patients resistant to the antiarrhythmic drugs (AADs).
NCT02110537 ↗	Acupuncture in Persistent Atrial Fibrillation	Unknown status	Kyunghee University Medical Center	N/A	2014-03-01	The aim of this trial is to evaluate the effect of acupuncture on prevention of atrial fibrillation (AF) recurrence after electrical cardioversion (EC) for persistent AF patients resistant to the antiarrhythmic drugs (AADs).

Clinical Trial Conditions for Tambocor

Condition Name

Condition Name for Tambocor
Intervention	Trials
Atrial Fibrillation	2
Ventricular Premature Complexes	2
Arrhythmogenic Right Ventricular Cardiomyopathy	1
Blood Pressure	1

Condition MeSH

Condition MeSH for Tambocor
Intervention	Trials
Atrial Fibrillation	4
Ventricular Premature Complexes	2
Premature Birth	2
Tachycardia, Ventricular	1

Clinical Trial Locations for Tambocor

Trials by Country

Trials by Country for Tambocor
Location	Trials
United States	36
Canada	2
Korea, Republic of	2
Netherlands	1
Czech Republic	1

Trials by US State

Trials by US State for Tambocor
Location	Trials
Pennsylvania	3
New York	3
Wisconsin	2
Colorado	2
Virginia	2

Clinical Trial Progress for Tambocor

Clinical Trial Phase

Clinical Trial Phase for Tambocor
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Tambocor
Clinical Trial Phase	Trials
Completed	2
Unknown status	2
Recruiting	1

Clinical Trial Sponsors for Tambocor

Sponsor Name

Sponsor Name for Tambocor
Sponsor	Trials
Medtronic Atrial Fibrillation Solutions	1
Medtronic Cardiac Rhythm and Heart Failure	1
University of Wisconsin, Madison	1

Sponsor Type

Sponsor Type for Tambocor
Sponsor	Trials
Other	7
Industry	5

Tambocor (Flecainide): Clinical Trials Update, Market Analysis, and Projections

Introduction to Flecainide (Tambocor)

Flecainide, marketed under the brand name Tambocor, is a medication used to prevent and treat abnormally fast heart rates, including ventricular and supraventricular tachycardias. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

RESTORE-1 Phase 3 Trial

One of the most significant recent developments in the clinical trials of flecainide is the RESTORE-1 Phase 3 trial conducted by InCarda Therapeutics. This trial aimed to evaluate the efficacy and safety of an inhaled flecainide acetate solution (FlecIH-103) for the acute conversion of paroxysmal atrial fibrillation (PAF) to sinus rhythm.

• Trial Outcomes: The RESTORE-1 trial was prematurely terminated after enrolling only 54 of the planned 400 patients due to lower-than-expected efficacy and plasma flecainide levels. Despite this, the trial showed a statistically significant cardioversion rate of 31% in the treated group compared to the placebo group[1][4].
• Challenges: The lower efficacy was attributed to drug-device incompatibility and lower-than-expected flecainide plasma levels, which were not observed in the previous Phase 2 INSTANT study[1][4].

Bridging Phase 1 Clinical Data

Following the RESTORE-1 trial, InCarda Therapeutics initiated a Phase 1 study in Australia using a novel drug delivery platform. This study has shown promising results:

• Peak Plasma Concentrations: The new delivery system achieved peak flecainide plasma concentrations similar to those in the Phase 2 INSTANT trial, but with only one-third of the drug amount needed compared to the previous nebulizer method[1][4].
• Safety Profile: The study observed transient electrocardiographic changes within safe ranges and no new safety signals or serious adverse events (SAEs)[1][4].

Future Development Plans

InCarda Therapeutics plans to continue the development of FlecIH-103 based on the encouraging data from the Phase 1 study:

• Completion of Phase 1 Study: The ongoing Phase 1 study will be completed, including the investigation of additional dose regimens such as booster doses similar to current approved products for treating cardiac arrhythmias[1][4].
• New Trials in 2025: InCarda plans to initiate new safety and efficacy trials in 2025, focusing on both medically supervised settings and portable self-administration for patients with PAF[1][4].

Market Analysis

Current Market Size and Forecast

The global market for flecainide was estimated to be worth US$ 922 million in 2023 and is forecasted to grow to US$ 1275.8 million by 2030, with a compound annual growth rate (CAGR) of 4.8% during the forecast period of 2024-2030[2].

Market Segmentation

The flecainide market is segmented by type, application, and region:

• By Type: The market includes various dosages such as 50mg, 100mg, and 150mg[5].
• By Application: Flecainide is used to treat ventricular and supraventricular tachycardias, and there are emerging applications such as the treatment of excessive daytime sleepiness (EDS) in combination with modafinil (THN102)[3][5].
• By Region: The market is analyzed across different regions including North America, Europe, Asia Pacific, and Latin America[5].

Competitive Landscape

The flecainide market is competitive, with several key players including Amneal Pharm, Ani Pharms, Aurobindo Pharma, Hikma, Sun Pharm, and others. These companies are involved in various development activities, mergers, and acquisitions to maintain their market share[2][5].

Market Projections

Growth Drivers

The growth of the flecainide market is driven by several factors:

• Increasing Prevalence of Cardiac Arrhythmias: The rising incidence of heart rhythm disorders is a significant driver for the demand of flecainide[5].
• Advancements in Drug Delivery Systems: The development of novel drug delivery platforms, such as the one used by InCarda Therapeutics, is expected to enhance the efficacy and safety of flecainide, further boosting its market[1][4].

Emerging Applications

Besides its traditional use in treating cardiac arrhythmias, flecainide is being explored for other applications:

• Excessive Daytime Sleepiness (EDS): The combination of flecainide with modafinil (THN102) is being studied for the treatment of EDS, which could expand the market for flecainide in the future[3].

Key Takeaways

• Clinical Trials: The RESTORE-1 Phase 3 trial, although prematurely terminated, showed promising results for inhaled flecainide in treating PAF.
• Market Size: The global flecainide market is projected to grow from US$ 922 million in 2023 to US$ 1275.8 million by 2030.
• Future Development: InCarda Therapeutics is advancing the development of FlecIH-103 with a new drug delivery platform and plans to initiate new trials in 2025.
• Emerging Applications: Flecainide is being explored for new applications, including the treatment of EDS.

FAQs

What was the outcome of the RESTORE-1 Phase 3 trial for inhaled flecainide?

The RESTORE-1 trial was prematurely terminated due to lower-than-expected efficacy and plasma flecainide levels, but it still demonstrated a statistically significant cardioversion rate of 31% in the treated group compared to the placebo group[1][4].

What are the future development plans for FlecIH-103?

InCarda Therapeutics plans to complete the ongoing Phase 1 study, explore additional dose regimens, and initiate new safety and efficacy trials in 2025 for both medically supervised and self-administration settings[1][4].

What is the projected market size for flecainide by 2030?

The global flecainide market is forecasted to reach US$ 1275.8 million by 2030, growing at a CAGR of 4.8% from 2024 to 2030[2].

What are the emerging applications for flecainide?

Besides treating cardiac arrhythmias, flecainide is being explored in combination with modafinil (THN102) for the treatment of excessive daytime sleepiness (EDS)[3].

Who are the key players in the flecainide market?

Key players include Amneal Pharm, Ani Pharms, Aurobindo Pharma, Hikma, Sun Pharm, and others[2][5].

Sources

1. InCarda Therapeutics Announces Results From the RESTORE-1 Phase 3 Trial and Plans for Continued Development. InCarda Therapeutics, September 30, 2024.
2. Flecainide - Market, Report Size, Worth, Revenue, Growth, Industry. Valuates Reports.
3. THN102 (Flecainide and Modafinil), Emerging Drug Insight and Market Forecast - 2032. Research and Markets.
4. InCarda Therapeutics Reveals RESTORE-1 Phase 3 Trial Results and Future Development Plans. Synapse, October 10, 2024.
5. Global Flecainide Market Research Report 2024. QYResearch.