CLINICAL TRIALS PROFILE FOR RAZADYNE ER

All Clinical Trials for RAZADYNE ER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00369603 ↗	Functional Brain Imaging of Medication Treatment Response in Mild Alzheimer's Disease Patients	Terminated	Ortho-McNeil Neurologics, Inc.	Phase 4	2006-10-01	The purpose of this study is to determine whether standard medications approved for Alzheimer's disease treatment differ in their action on brain functioning and whether any observed brain activity differences as result of treatment are associated with particular patterns of dementia improvement or reduced decline.
NCT00348140 ↗	Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease	Completed	GlaxoSmithKline	Phase 3	2006-07-12	Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG. This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.
NCT00232349 ↗	Efficacy of Galantamine to Treat Schizophrenia	Terminated	Seattle Institute for Biomedical and Clinical Research	Phase 4	2005-02-01	The purpose of this study was to determine if treatment with adjunctive galantamine is effective in the reduction of functional impairments in patients with schizophrenia and schizoaffective disorder. It was hypothesized that adjunctive galantamine would yield clinically significant improvements from baseline to end of study on a measure of quality of life and a measure of independent living skills.
NCT00227994 ↗	Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke	Completed	National Institute of Mental Health (NIMH)	Phase 4	2003-04-01	This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.
NCT00227994 ↗	Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke	Completed	University of Pittsburgh	Phase 4	2003-04-01	This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.

Clinical Trial Conditions for RAZADYNE ER

Condition Name

Condition Name for RAZADYNE ER
Intervention	Trials
Alzheimer's Disease	4
Schizophrenia	4
Tobacco Use Disorder	2
Schizoaffective Disorder	2

Condition MeSH

Condition MeSH for RAZADYNE ER
Intervention	Trials
Alzheimer Disease	5
Schizophrenia	4
Tobacco Use Disorder	3
Psychotic Disorders	3

Clinical Trial Locations for RAZADYNE ER

Trials by Country

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−

Trials by Country for RAZADYNE ER
Location	Trials
United States	45
Germany	7
Canada	6
Australia	5
United Kingdom	2

Trials by US State

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−

Trials by US State for RAZADYNE ER
Location	Trials
Pennsylvania	5
Tennessee	4
North Carolina	3
Massachusetts	3
Maryland	2

Clinical Trial Progress for RAZADYNE ER

Clinical Trial Phase

Clinical Trial Phase for RAZADYNE ER
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2	7

Clinical Trial Status

Clinical Trial Status for RAZADYNE ER
Clinical Trial Phase	Trials
Completed	13
Terminated	5
Active, not recruiting	1

Clinical Trial Sponsors for RAZADYNE ER

Sponsor Name

Sponsor Name for RAZADYNE ER
Sponsor	Trials
Vanderbilt University Medical Center	4
National Institute on Drug Abuse (NIDA)	3
National Institute of Mental Health (NIMH)	3

Sponsor Type

Sponsor Type for RAZADYNE ER
Sponsor	Trials
Other	23
NIH	12
Industry	6

Razadyne ER: Clinical Trials, Market Analysis, and Projections

Introduction to Razadyne ER

Razadyne ER, known generically as galantamine, is a prescription medication used to treat mild to moderate Alzheimer's disease. It is classified as a reversible acetylcholinesterase inhibitor, which works by increasing the concentration of acetylcholine in the brain, thereby enhancing cholinergic function[2][5].

Mechanism of Action

Galantamine exerts its therapeutic effect by competitively and reversibly inhibiting the enzyme acetylcholinesterase. This inhibition prevents the breakdown of acetylcholine, a neurotransmitter crucial for cognitive functions. Although the precise mechanism is not fully understood, it is believed to improve cognitive symptoms associated with Alzheimer's disease by maintaining higher levels of acetylcholine in the brain[1][2].

Clinical Trials

Efficacy and Dosage

Clinical trials have demonstrated the efficacy of Razadyne ER in treating mild to moderate Alzheimer's disease. The effective dosage range in controlled clinical trials was found to be 16-24 mg/day for the extended-release formulation. Patients who were previously on immediate-release tablets could be switched to the extended-release capsules, with the dosage adjusted accordingly[5].

Safety and Tolerability

Clinical trials also highlighted the safety and tolerability profile of Razadyne ER. Common adverse reactions include nausea, vomiting, diarrhea, dizziness, and headache. To minimize gastrointestinal side effects, the dose is typically increased gradually over a period of weeks. Serious skin reactions, although rare, have been reported and require immediate medical attention[1][5].

Comparative Studies

Studies comparing Razadyne ER with other formulations, such as immediate-release tablets and oral solutions, have shown that the extended-release formulation offers a more convenient once-daily dosing regimen. This can improve patient compliance and reduce the burden of multiple daily doses[2][5].

Market Analysis

Historical Performance

Razadyne, initially approved in 2001 under the name Reminyl, was later renamed in 2005 to avoid confusion with another medication. The immediate-release formulation peaked in sales in 2004 with $247 million in the US market. However, with the introduction of the extended-release formulation, Razadyne ER, in December 2004, the market share began to shift. By 2005, Razadyne ER had posted $25 million in US sales, with a significant increase in prescriptions dispensed[3].

Market Share and Competition

The Alzheimer's disease treatment market is highly competitive, with other cholinesterase inhibitors like Aricept and Namenda dominating the market. These drugs are often used in combination, which has contributed to their market success. Despite this, Razadyne ER has carved out a niche, particularly with its once-daily dosing convenience and its approval in 24 countries[3].

Sales Projections

The sales of Razadyne ER have shown potential for growth, especially as it gains more acceptance among healthcare providers and patients. However, the overall market for Alzheimer's treatments is subject to various factors, including the emergence of new therapies and changes in treatment guidelines. As of the mid-2000s, sales projections indicated that Razadyne ER could see significant growth, potentially tripling its sales in subsequent years[3].

Market Trends and Future Outlook

Emerging Therapies

The Alzheimer's disease treatment landscape is evolving with the development of new therapies. While cholinesterase inhibitors like Razadyne ER remain a cornerstone of treatment, other classes of drugs and innovative delivery systems are being explored. For instance, Alpha Cognition's ALPHA-1062, which has shown a favorable gastrointestinal side effect profile compared to traditional galantamine formulations, could impact the market dynamics[4].

Patient Compliance and Convenience

The once-daily dosing regimen of Razadyne ER has been a significant factor in its market appeal. Patient compliance is crucial in the management of chronic conditions like Alzheimer's disease, and convenient dosing schedules can enhance adherence to treatment plans.

Regulatory and Economic Factors

Regulatory approvals and economic factors also play a critical role in the market performance of Razadyne ER. Generic versions of galantamine are available, which can affect the market share of the branded product. However, the extended-release formulation's convenience and the brand's established reputation can help maintain its market position[2][3].

Key Takeaways

• Mechanism of Action: Razadyne ER works by inhibiting acetylcholinesterase, thereby increasing acetylcholine levels in the brain.
• Clinical Trials: Effective in treating mild to moderate Alzheimer's disease with a dosage range of 16-24 mg/day.
• Market Performance: Initially strong sales for the immediate-release formulation, with the extended-release formulation gaining traction since its introduction.
• Competition: Faces competition from other cholinesterase inhibitors but benefits from its once-daily dosing convenience.
• Future Outlook: Potential for growth, influenced by emerging therapies, patient compliance, and regulatory factors.

FAQs

Q: What is Razadyne ER used for?

Razadyne ER is used to treat mild to moderate Alzheimer's disease by enhancing cholinergic function in the brain[2].

Q: How is Razadyne ER administered?

Razadyne ER is administered once daily in the morning, preferably with food, to minimize gastrointestinal side effects[2].

Q: What are the common side effects of Razadyne ER?

Common side effects include nausea, vomiting, diarrhea, dizziness, and headache. Serious skin reactions and other adverse effects can also occur[1][5].

Q: Is Razadyne ER available as a generic?

Yes, all dosage forms of Razadyne, including immediate-release tablets, extended-release capsules, and oral solution, are available as generics in the US[2].

Q: How does Razadyne ER compare to other Alzheimer's treatments?

Razadyne ER offers a convenient once-daily dosing regimen and is approved in 24 countries, but it competes with other dominant cholinesterase inhibitors like Aricept and Namenda[3].

Sources

1. RAZADYNE ER Prescription & Dosage Information - eMPR.com
2. Is Razadyne (galantamine) used to treat Alzheimer’s? - Drugs.com
3. The Age of Alzheimer's - MM+M - Medical Marketing and Media
4. Corporate Presentation - Alpha Cognition
5. Razadyne ER - RxList