CLINICAL TRIALS PROFILE FOR NEURONTIN

All Clinical Trials for neurontin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001482 ↗	New Drugs in the Treatment of Mood Disorders	Completed	National Institute of Mental Health (NIMH)	Phase 2	1995-05-01	This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so that we examine possible clinical and biological factors predictors of response. The drugs will be given in a randomized order for six weeks each and you will not know when you are on a given one. There will be a 2-4 week "washout" period between treatments. If you respond well to one of these treatments, a longer open continuation period will be offered at the end of this study. This would involve one or both drugs in combination. A variety of rating scales and brain imaging procedures will also be offered before and during each drug evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine, however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually mild, and resolve with continued time on the drug or a decrease in dosage.
NCT00011297 ↗	Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	1969-12-31	This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.
NCT00108550 ↗	Chronic Low Back Pain Research Project	Completed	US Department of Veterans Affairs	Phase 2	2004-10-01	The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain.
NCT00108550 ↗	Chronic Low Back Pain Research Project	Completed	VA Office of Research and Development	Phase 2	2004-10-01	The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain.
NCT00112138 ↗	Gabapentin for the Treatment of Hot Flashes in Menopausal Women	Completed	North Toronto Primary Care Research Network	Phase 3	2004-03-01	The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared to placebo in the treatment of hot flashes in postmenopausal women using a phase III randomized controlled trial.
NCT00137735 ↗	Gabapentin for Carpal Tunnel Syndrome	Completed	Pfizer	Phase 3	2003-10-01	The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).
NCT00137735 ↗	Gabapentin for Carpal Tunnel Syndrome	Completed	Chinese University of Hong Kong	Phase 3	2003-10-01	The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).

Clinical Trial Conditions for neurontin

Condition Name

Condition Name for neurontin
Intervention	Trials
Pain	17
Healthy	13
Pain, Postoperative	8
Postoperative Pain	7

Condition MeSH

Condition MeSH for neurontin
Intervention	Trials
Pain, Postoperative	24
Head and Neck Neoplasms	6
Alcoholism	5
Syndrome	5

Clinical Trial Locations for neurontin

Trials by Country

Trials by Country for neurontin
Location	Trials
United States	90
Canada	11
Egypt	2
Venezuela	2
Thailand	2

Trials by US State

Trials by US State for neurontin
Location	Trials
California	13
New York	10
North Carolina	7
North Dakota	6
Minnesota	6

Clinical Trial Progress for neurontin

Clinical Trial Phase

Clinical Trial Phase for neurontin
Clinical Trial Phase	Trials
Phase 4	44
Phase 3	11
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for neurontin
Clinical Trial Phase	Trials
Completed	74
Terminated	16
Unknown status	12

Clinical Trial Sponsors for neurontin

Sponsor Name

Sponsor Name for neurontin
Sponsor	Trials
Actavis Inc.	6
Ranbaxy Laboratories Limited	4
University of California, Davis	4

Sponsor Type

Sponsor Type for neurontin
Sponsor	Trials
Other	123
Industry	24
NIH	19

Neurontin Market Analysis and Financial Projection

Neurontin (Gabapentin): Clinical Trials, Market Analysis, and Projections

Introduction to Neurontin (Gabapentin)

Neurontin, known generically as gabapentin, is a versatile pharmaceutical drug used primarily in the management of neurological conditions such as epilepsy and neuropathic pain. It operates by modulating nerve activity in the brain and nervous system, providing relief and improving the quality of life for patients suffering from these conditions.

Clinical Trials and Efficacy

Efficacy in Clinical Studies

Clinical studies have demonstrated the efficacy of gabapentin across a range of doses from 1800 mg/day to 3600 mg/day. For postherpetic neuralgia, gabapentin has shown significant benefits, with somnolence, dizziness, and peripheral edema being the most common adverse reactions[1].

In the treatment of partial onset seizures, gabapentin has been effective as an adjunctive therapy in adults and pediatric patients 3 years and older with epilepsy. The drug has been associated with adverse reactions such as somnolence, dizziness, ataxia, fatigue, and nystagmus in patients over 12 years of age[1].

Safety and Adverse Reactions

Gabapentin's safety profile includes several important considerations. Patients should be monitored for signs of central nervous system (CNS) depression, such as somnolence and sedation, especially when used with other sedative drugs. The drug can impair the ability to drive or operate heavy machinery, and abrupt discontinuation can lead to increased seizure frequency or status epilepticus[1].

Additionally, gabapentin is associated with an increased risk of suicidal thoughts or behavior, similar to other antiepileptic drugs. It is also important to monitor for neuropsychiatric adverse reactions in children aged 3 to 12 years[1].

Market Analysis

Current Market Size and Growth

The global gabapentin market has been growing steadily, driven by several key factors. As of 2023, the market size was estimated to be around USD 2.75 billion and is projected to surpass USD 4.95 billion by 2033, registering a Compound Annual Growth Rate (CAGR) of 6.12% during the forecast period from 2024 to 2033[2].

In the U.S., the gabapentin market size was valued at USD 700 million in 2023 and is expected to reach around USD 1,320 million by 2033, growing at a CAGR of 6.64% from 2024 to 2033. North America holds the largest revenue share, accounting for 36.12% of the global market in 2023[2].

Market Drivers

Several factors are driving the growth of the gabapentin market:

Rising Prevalence of Neuropathic Pain

The increasing incidence of neuropathic pain conditions, such as diabetic neuropathy and post-herpetic neuralgia, is a significant driver. Gabapentin's recognized efficacy in managing these pain conditions fuels its demand[2][3][5].

Expanding Applications and Off-Label Usage

Gabapentin's versatility in treating various medical conditions beyond its initial intended use, including anxiety disorders, migraines, and restless legs syndrome, contributes to market growth. Off-label prescriptions for these conditions broaden its market reach and fuel demand[3][5].

Aging Population and Healthcare Advancements

The growing aging population, particularly in regions like North America and the Asia-Pacific, leads to increased cases of neurological disorders and chronic pain conditions. Improved access to healthcare services and rising awareness about gabapentin's efficacy also drive its demand[2][3].

Market Challenges

Despite the growth, the gabapentin market faces several challenges:

Regulatory Scrutiny

Efforts to combat misuse and abuse of gabapentin have led to stricter regulatory practices, which can impact prescription rates and market growth[2].

Side Effects and Safety Concerns

The drug's side effects, such as somnolence, dizziness, and potential for CNS depression, can hinder market growth. Additionally, the risk of suicidal thoughts or behavior and neuropsychiatric adverse reactions in children are significant safety concerns[1].

Cost and Health Remuneration Policies

The lack of health remuneration policies and the rising cost of the drug can also act as barriers to market growth[3].

Regional Market Outlook

North America

North America is the largest market for gabapentin, driven by the rising prevalence of neuropathic pain conditions and an aging population. The U.S. market, in particular, is expected to grow significantly, driven by continued demand and regulatory scrutiny aimed at managing misuse[2].

Asia-Pacific

The Asia-Pacific region is estimated to observe the fastest expansion in the gabapentin market. This growth is driven by demographic shifts, including an aging population, and improvements in healthcare access and awareness about gabapentin's efficacy. However, the region faces challenges related to regulatory variations across countries[2].

Distribution Channels and Product Types

Distribution Channels

The gabapentin market is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies and retail pharmacies remain the dominant distribution channels due to their widespread presence and patient preference[2][3].

Product Types

Gabapentin is available in several forms, including tablets, capsules, and oral solutions. The tablet segment is expected to dominate the market due to patient preference and ease of administration[3].

Key Takeaways

• Growing Market Size: The global gabapentin market is projected to grow from USD 2.75 billion in 2023 to USD 4.95 billion by 2033.
• Regional Dominance: North America holds the largest revenue share, with the U.S. market expected to reach USD 1,320 million by 2033.
• Drivers: Rising prevalence of neuropathic pain, expanding applications, and an aging population are key drivers.
• Challenges: Regulatory scrutiny, side effects, and cost concerns are significant challenges.
• Distribution: Hospital and retail pharmacies are the primary distribution channels.

FAQs

What are the primary indications for Neurontin (gabapentin)?

Neurontin is indicated for postherpetic neuralgia in adults and as an adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy[1].

What are the common adverse reactions associated with gabapentin?

Common adverse reactions include somnolence, dizziness, ataxia, fatigue, and nystagmus in patients with epilepsy, and dizziness, somnolence, and peripheral edema in patients with postherpetic neuralgia[1].

How is the global gabapentin market expected to grow?

The global gabapentin market is projected to grow from USD 2.75 billion in 2023 to USD 4.95 billion by 2033, registering a CAGR of 6.12% during the forecast period from 2024 to 2033[2].

What are the key drivers of the gabapentin market?

The rising prevalence of neuropathic pain, expanding applications and off-label usage, and an aging population are key drivers of the gabapentin market[2][3][5].

Which region is expected to see the fastest growth in the gabapentin market?

The Asia-Pacific region is estimated to observe the fastest expansion in the gabapentin market, driven by demographic shifts and improvements in healthcare access and awareness[2].

What are the main distribution channels for gabapentin?

The main distribution channels for gabapentin include hospital pharmacies, retail pharmacies, and online pharmacies, with hospital and retail pharmacies being the dominant channels[2][3].

Sources

1. NEURONTIN (gabapentin) - accessdata.fda.gov
   • Highlights of Prescribing Information for NEURONTIN.
2. Gabapentin Market Size To Surpass USD 4.95 Billion By 2033 - Precedence Research
   • Global gabapentin market analysis and forecast.
3. Gabapentin Market Size, Share, Scope & Industry Analysis By 2030 - Data Bridge Market Research
   • Global gabapentin market analysis and forecast.
4. Clinical Update 2024: Gabapentin (Neurontin) and Pregnancy - Women's Mental Health
   • Study on gabapentin use during pregnancy.
5. Gabapentin Market Analysis, Statistics & Forecast, 2024-2032 - Global Market Insights
   • Global gabapentin market analysis and forecast.