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CLINICAL TRIALS PROFILE FOR FYCOMPA

All Clinical Trials for fycompa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00903786 ↗	A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)	Completed	Eisai Co., Ltd.	Phase 2	2009-06-17	The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
NCT02033902 ↗	A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years	Completed	Eisai Inc.		2014-06-06	The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.
NCT02220972 ↗	To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures	Withdrawn	Eisai Inc.	Phase 4	2015-03-01	This will be a multi-center, randomized, double-blind, placebo-controlled, crossover study to evaluate the effects of 2007/Fycompa (perampanel) on sleep, in subjects with well controlled partial onset seizures (on an antiepileptic drug [AED] monotherapy) who are experiencing sleep onset insomnia.
NCT02363933 ↗	Perampanel in Seizure Patients With Primary Glial Brain Tumors	Completed	Duke University	Phase 4	2015-04-07	This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose can be modified by the physician based on patient reported tolerability. Titration and taper periods will be determined by the physician in the case where patients do not reach the planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24 weeks. Assessments will include history and physical examination (H&P) including Karnofsky Performance Status (KPS), neurological examination, evaluation of seizure history, patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of 16 weeks of therapy, perampanel will be tapered down. At Week 17, patients will begin taking 6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they will no longer take perampanel. Patients will be considered off treatment at the end of week 20, once perampanel has cleared their system. Patients will then be monitored through Week 24. Patients will continue to take their original AED regimen after they stop perampanel. If seizure control is achieved during the maintenance period or if seizures occur during the tapering period, patients can be continued on perampanel per the discretion of the treating physician. In this instance, perampanel will be prescribed by the treating physician and not provided within the confines of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As is standard procedure at the Preston Robert Tisch Brain Tumor Center (PRTBTC), patients will be given a log to record the number of seizures that occur. Research team members will regularly contact patients for reminders and reports from the log. Safety will be assessed with the following laboratory evaluations: complete blood count (CBC) with differential, complete metabolic panel (CMP), and toxicity assessment.

Clinical Trial Conditions for fycompa

Condition Name

Condition Name for fycompa
Intervention	Trials
Epilepsy	6
Amyotrophic Lateral Sclerosis	3
Partial Onset Seizures	2
Pediatric Epileptic Syndrome	1

Condition MeSH

Condition MeSH for fycompa
Intervention	Trials
Epilepsy	12
Seizures	9
Sclerosis	3
Motor Neuron Disease	3

Clinical Trial Locations for fycompa

Trials by Country

Trials by Country for fycompa
Location	Trials
United States	44
Japan	15
Belgium	5
Czechia	2
Korea, Republic of	2

Trials by US State

Trials by US State for fycompa
Location	Trials
Florida	4
New York	4
Arizona	4
Michigan	3
California	3

Clinical Trial Progress for fycompa

Clinical Trial Phase

Clinical Trial Phase for fycompa
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status for fycompa
Clinical Trial Phase	Trials
Completed	8
Recruiting	6
Not yet recruiting	3

Clinical Trial Sponsors for fycompa

Sponsor Name

Sponsor Name for fycompa
Sponsor	Trials
Eisai Inc.	11
Eisai Co., Ltd.	3
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for fycompa
Sponsor	Trials
Other	16
Industry	15
NIH	2

Fycompa Market Analysis and Financial Projection

FYCOMPA (Perampanel): Clinical Trials, Market Analysis, and Projections

Introduction to FYCOMPA

FYCOMPA (perampanel) is an AMPA receptor antagonist used in the treatment of epilepsy. It is indicated for patients with epilepsy aged 4 years and older for partial-onset seizures (POS) with or without secondarily generalized seizures, and as adjunctive therapy for patients aged 12 years and older for primary generalized tonic-clonic (PGTC) seizures[1][4].

Clinical Trials Overview

ELEVATE Study

The ELEVATE study, a 12-month, multicenter, open-label trial, evaluated the efficacy and tolerability of FYCOMPA as monotherapy and as an early add-on therapy. The study included a screening period, a titration period (up to 13 weeks), a maintenance period (39 weeks), and a 4-week follow-up. Patients started with a dose of 2 mg/day, which was titrated to 4 mg/day and could be increased up to 12 mg/day based on response and tolerability. The primary endpoint was the retention rate at 3, 6, 9, and 12 months, while secondary endpoints included seizure freedom rate during the maintenance period. The study also explored cognitive and depressive effects using tools like EpiTrack® and the BDI-II[1].

PGTC Seizures Trials

FYCOMPA received FDA approval as adjunctive therapy for PGTC seizures based on a multicenter, randomized, double-blind, placebo-controlled clinical trial. During the trial, patients were titrated up to a dose of 8 mg per day or the highest tolerated dose. The maintenance period showed that nearly one in three patients (31%) experienced convulsive seizure freedom compared to 12% in the placebo group[4].

Pediatric Trials

Clinical trials are also ongoing to evaluate the safety and efficacy of FYCOMPA in children aged 1 month to less than 4 years for the adjunctive treatment of partial-onset seizures. These trials include a controlled phase and a long-term safety extension, with primary efficacy endpoints based on seizure frequency from Video/EEG data[3].

Market Analysis

Current Market Position

FYCOMPA has been a significant player in the epilepsy treatment market since its approval in 2012. Eisai estimated FYCOMPA's U.S. sales to be around $136 million at the end of March 2023. However, Eisai has recently divested the U.S. rights of FYCOMPA to Catalyst Pharmaceuticals for $160 million upfront, along with milestone and royalty payments[2][5].

Acquisition by Catalyst Pharmaceuticals

Catalyst Pharmaceuticals completed the acquisition of the U.S. rights to FYCOMPA in January 2023. This move is expected to be accretive to Catalyst's EBITDA and EPS in 2023, strengthening its presence in neuroscience and providing a complementary growth driver. The acquisition aligns with Catalyst's growth plans, leveraging the overlap in physician call points between FYCOMPA and their existing product, Firdapse[5].

Patent Protection

FYCOMPA's patent protection is expected to last until at least May 2025, with a possible extension into June 2026. This protection period is crucial for maintaining market exclusivity and revenue generation[2][5].

Market Projections

Revenue Growth

With the acquisition by Catalyst, FYCOMPA is expected to contribute significantly to the company's revenue growth. Catalyst reported an 18% revenue increase in 2021 to $141 million, and the addition of FYCOMPA is anticipated to further bolster this growth. The synergies between FYCOMPA and Firdapse, particularly in overlapping physician call points, are expected to enhance commercial execution and revenue generation[5].

Competitive Landscape

The epilepsy treatment market is competitive, but FYCOMPA's unique mechanism as an AMPA receptor antagonist positions it favorably. The drug's efficacy in reducing seizure frequency and its approval for both partial-onset and PGTC seizures make it a valuable option for clinicians. As Catalyst continues to expand its portfolio, FYCOMPA is likely to remain a key asset in the company's neuroscience segment[4].

Future Expansion

Catalyst's acquisition of FYCOMPA also includes an option to acquire another unnamed epilepsy asset in Eisai’s pipeline. This strategic move indicates Catalyst's commitment to expanding its presence in rare epileptic diseases, potentially opening up new market opportunities and further diversifying its revenue streams[2].

Key Takeaways

• Clinical Efficacy: FYCOMPA has demonstrated efficacy in clinical trials for both partial-onset and PGTC seizures, with significant seizure freedom rates.
• Market Transition: The U.S. rights to FYCOMPA have been acquired by Catalyst Pharmaceuticals, expected to enhance revenue growth and market presence.
• Patent Protection: FYCOMPA’s patent protection is set to last until at least May 2025, with a possible extension into June 2026.
• Revenue Projections: The acquisition is anticipated to be accretive to Catalyst’s EBITDA and EPS, contributing to overall revenue growth.
• Future Expansion: Catalyst is poised to expand its portfolio in neuroscience, potentially including other epilepsy assets.

FAQs

Q: What is FYCOMPA indicated for?

A: FYCOMPA is indicated for patients with epilepsy aged 4 years and older for partial-onset seizures (POS) with or without secondarily generalized seizures and as adjunctive therapy for patients aged 12 years and older for primary generalized tonic-clonic (PGTC) seizures[1].

Q: Who acquired the U.S. rights to FYCOMPA?

A: Catalyst Pharmaceuticals acquired the U.S. rights to FYCOMPA from Eisai for $160 million upfront, along with milestone and royalty payments[2][5].

Q: What is the expected patent protection period for FYCOMPA?

A: FYCOMPA’s patent protection is expected to last until at least May 2025, with a possible extension into June 2026[2][5].

Q: How does FYCOMPA compare to other epilepsy treatments?

A: FYCOMPA's unique mechanism as an AMPA receptor antagonist sets it apart. It has shown significant efficacy in reducing seizure frequency and is approved for both partial-onset and PGTC seizures[4].

Q: What are the future growth plans for FYCOMPA under Catalyst Pharmaceuticals?

A: Catalyst plans to leverage FYCOMPA as a complementary growth driver, expanding its presence in neuroscience and potentially acquiring other epilepsy assets to diversify its revenue streams[5].

Sources

1. Eisai Presents Final Results Of Phase IV Elevate Study Of Anti-Epileptic Drug FYCOMPA (Perampanel) At The American Epilepsy Society (AES) 2021 Annual Meeting. PR Newswire.
2. Eisai peddles US rights to epilepsy drug Fycompa to Catalyst. FiercePharma.
3. FYCOMPA (perampanel) NDA 202834. FDA.
4. Clinical Trials: PGTC Seizures - FYCOMPA® (perampanel) CIII. FYCOMPA.
5. Catalyst Pharmaceuticals Completes the Acquisition of U.S. Rights to FYCOMPA® (Perampanel) CIII. Catalyst Pharmaceuticals.