CLINICAL TRIALS PROFILE FOR RYANODEX

All Clinical Trials for ryanodex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02513095 ↗	Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)	Completed	Quintiles, Inc.	Phase 2	2015-09-01	Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is defined as effective body cooling, which should be implemented as quickly as available after diagnosis of exertional heat stroke.
NCT02513095 ↗	Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)	Completed	Eagle Pharmaceuticals, Inc.	Phase 2	2015-09-01	Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is defined as effective body cooling, which should be implemented as quickly as available after diagnosis of exertional heat stroke.
NCT03189433 ↗	Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)	Terminated	Eagle Pharmaceuticals, Inc.	Phase 2	2017-08-12	Ryanodex is being investigated as a potential adjuvant treatment for people suffering from psychostimulant drug-induced toxicity (PDIT), a life-threatening medical condition that results mainly from the abuse of certain illicit drugs, most notably methamphetamine, and related forms (MDMC or "Molly"; MDMA or "Ecstasy"). Ryanodex is approved for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for prevention of malignant hyperthermia in patients at high risk and in this study, will be investigated for the treatment of PDIT. The hypothesis of this study is that administration of Ryanodex as adjuvant treatment to Standard of Care (SOC) will improve the clinical outcome compared with SOC alone, in subjects with psychostimulant drug induced toxicity. Current SOC is defined as body cooling and supportive measures.
NCT03600376 ↗	Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS	Completed	Eagle Pharmaceuticals, Inc.	Phase 3	2018-08-19	A double-blind, parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) compared to current Standard of Care (SOC) for EHS.

Clinical Trial Conditions for ryanodex

Condition Name

Condition Name for ryanodex
Intervention	Trials
Psychostimulant Drug Induced Toxicity	1
Drug Toxicity Psychotropic Agents Psychostimulants	1
Exertional Heat Stroke	1
Heat Stroke	1

Condition MeSH

Condition MeSH for ryanodex
Intervention	Trials
Stroke	2
Heat Stroke	2
Sunstroke	2
Drug-Related Side Effects and Adverse Reactions	1

Clinical Trial Locations for ryanodex

Trials by Country

Trials by Country for ryanodex
Location	Trials
Saudi Arabia	2
United States	1

Trials by US State

Trials by US State for ryanodex
Location	Trials
Maryland	1

Clinical Trial Progress for ryanodex

Clinical Trial Phase

Clinical Trial Phase for ryanodex
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for ryanodex
Clinical Trial Phase	Trials
Completed	2
Terminated	1

Clinical Trial Sponsors for ryanodex

Sponsor Name

Sponsor Name for ryanodex
Sponsor	Trials
Eagle Pharmaceuticals, Inc.	3
Quintiles, Inc.	1

Sponsor Type

Sponsor Type for ryanodex
Sponsor	Trials
Industry	4

Ryanodex Market Analysis and Financial Projection

RYANODEX: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to RYANODEX

RYANODEX, developed by Eagle Pharmaceuticals, is a formulation of dantrolene sodium designed for the treatment of malignant hyperthermia (MH) and other potential indications. Here, we will delve into the latest updates on its clinical trials, market analysis, and future projections.

Mechanism of Action and Current Indications

RYANODEX acts as a ryanodine receptor 1 antagonist, inhibiting abnormal calcium release from the sarcoplasmic reticulum, which leads to muscle relaxation. It is currently indicated for the treatment and prevention of malignant hyperthermia in conjunction with appropriate supportive measures[2].

Clinical Trials Update

Malignant Hyperthermia Trials

RYANODEX has been extensively tested for its efficacy in treating MH. The drug's nanosuspension technology allows for rapid reconstitution and administration, significantly reducing the time to administer the drug compared to other formulations of dantrolene sodium. Clinical trials have shown that RYANODEX can be reconstituted and administered in less than 1 minute, which is crucial in minimizing complications associated with MH[2].

COVID-19 Clinical Trials

In response to the COVID-19 pandemic, Eagle Pharmaceuticals conducted laboratory tests that showed RYANODEX inhibited the growth of SARS-CoV-2. Based on these findings, the company submitted an Investigational New Drug (IND) application to the FDA to initiate a Phase II clinical trial. This trial aims to evaluate the efficacy and safety of RYANODEX in patients hospitalized with COVID-19. The trial will enroll approximately 60 adult patients and use the World Health Organization Ordinal Scale of Severity and other relevant clinical measurements as efficacy endpoints[1].

Market Analysis

Current Market Position

RYANODEX holds a unique position in the market due to its advanced nanosuspension technology, which enables rapid and efficient administration. This feature is particularly valuable in emergency situations where every minute counts. The drug has been granted seven years of U.S. market exclusivity for the treatment of MH by the FDA, providing a competitive edge[5].

Market Demand and Growth Potential

The demand for effective treatments for MH and other severe conditions like exertional heat stroke (EHS) is significant. EHS, for example, is a leading cause of death in young athletes and non-combat related fatalities in the military, yet there are no approved drug treatments available. The FDA's Fast Track designation for RYANODEX for the treatment of EHS highlights the unmet medical need and the potential for market expansion[5].

Market Projections

Expansion into New Indications

Given the success of RYANODEX in treating MH and its potential antiviral activity against SARS-CoV-2, the drug is poised for expansion into new indications. The ongoing Phase II trial for COVID-19 treatment and the Fast Track designation for EHS treatment suggest a broadening market scope. If these trials are successful, RYANODEX could become a key player in the treatment of various critical conditions.

Competitive Landscape

The pharmaceutical market for emergency and critical care treatments is highly competitive. However, RYANODEX's unique formulation and rapid administration capabilities give it a competitive advantage. As the company continues to explore new indications and receives favorable regulatory designations, it is likely to maintain and enhance its market position.

Regulatory Support and Expedited Review

The FDA has been supportive of RYANODEX's development, granting it Fast Track designation for the treatment of EHS and potentially expediting the review of its IND application for COVID-19 treatment. This regulatory support is crucial for accelerating the drug's development and approval process, which can significantly impact its market availability and adoption[1][5].

Financial Implications and Future Outlook

Eagle Pharmaceuticals' financial performance is closely tied to the success of RYANODEX. Positive outcomes from ongoing clinical trials could lead to increased revenue and market value. The company's strategy of utilizing the FDA’s 505(b)(2) regulatory pathway also streamlines the development process, potentially reducing costs and time to market[5].

Key Takeaways

• Rapid Administration: RYANODEX's nanosuspension technology allows for quick reconstitution and administration, critical in emergency situations.
• COVID-19 Trials: The drug is being tested for its efficacy against SARS-CoV-2, with a Phase II trial underway.
• Market Exclusivity: RYANODEX has seven years of U.S. market exclusivity for MH treatment.
• Expansion Potential: The drug is being explored for new indications, including EHS, with FDA Fast Track designation.
• Regulatory Support: The FDA has provided favorable designations and potential expedited reviews, supporting the drug's development.

FAQs

What is RYANODEX used for?

RYANODEX is primarily used for the treatment and prevention of malignant hyperthermia (MH). It is also being explored for other indications such as exertional heat stroke (EHS) and COVID-19.

How does RYANODEX work?

RYANODEX acts as a ryanodine receptor 1 antagonist, inhibiting abnormal calcium release from the sarcoplasmic reticulum, leading to muscle relaxation.

What makes RYANODEX unique?

RYANODEX's nanosuspension technology allows for rapid reconstitution and administration, making it significantly faster than other formulations of dantrolene sodium.

Is RYANODEX being tested for COVID-19?

Yes, RYANODEX is being tested in a Phase II clinical trial for its efficacy and safety in patients hospitalized with COVID-19.

What regulatory support has RYANODEX received?

RYANODEX has received Fast Track designation from the FDA for the treatment of exertional heat stroke and potential expedited review for its IND application for COVID-19 treatment.

Sources

1. Biospace: Eagle Pharmaceuticals Plans to Aim Ryanodex at COVID-19 in Phase II Trial
2. RYANODEX.com: RYANODEX® (dantrolene sodium) | RYANODEX® for MH
3. Business Wire: Eagle Pharmaceuticals Reports First Quarter 2020 Results
4. FDA: 205579Orig1s000 - accessdata.fda.gov
5. Biospace: FDA Grants Fast Track Designation To RYANODEX For Treatment Of Exertional Heat Stroke