CLINICAL TRIALS PROFILE FOR PREGABALIN

505(b)(2) Clinical Trials for Pregabalin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00209495 ↗	Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients	Completed	Glostrup University Hospital, Copenhagen	Phase 4	2005-06-01	Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
New Combination	NCT00235261 ↗	Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations	Completed	Glostrup University Hospital, Copenhagen	Phase 4	2005-10-01	Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine and improve the patients pain score after operation.
New Combination	NCT00378547 ↗	Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy	Terminated	Glostrup University Hospital, Copenhagen	Phase 4	2006-01-01	Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.
New Formulation	NCT01638273 ↗	PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects	Completed	GL Pharm Tech Corporation	Phase 1	2014-02-01	The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
New Formulation	NCT02326987 ↗	A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS-NF1 Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects	Completed	GL Pharm Tech Corporation	Phase 1	2013-10-01	The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".

All Clinical Trials for Pregabalin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00035412 ↗	St. John's Wort Versus Placebo in Social Phobia	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 2	2001-12-01	The purpose of this study is to determine the effectiveness of St. John's Wort as compared to placebo (an inactive substance) in the treatment of outpatients with social phobia.
NCT00141219 ↗	Pregabalin Peripheral Neuropathic Pain Study	Completed	Pfizer	Phase 3	2005-12-01	To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
NCT00141219 ↗	Pregabalin Peripheral Neuropathic Pain Study	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2005-12-01	To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
NCT00141245 ↗	To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.	Completed	Pfizer	Phase 3	1998-10-01	To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.
NCT00141258 ↗	Pregabalin Epilepsy Add-On Trial	Completed	Pfizer	Phase 3	2005-10-01	To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures

Clinical Trial Conditions for Pregabalin

Condition Name

Condition Name for Pregabalin
Intervention	Trials
Pain	34
Healthy	33
Fibromyalgia	33
Neuropathic Pain	29

Condition MeSH

Condition MeSH for Pregabalin
Intervention	Trials
Neuralgia	99
Pain, Postoperative	74
Diabetic Neuropathies	49
Peripheral Nervous System Diseases	43

Clinical Trial Locations for Pregabalin

Trials by Country

Trials by Country for Pregabalin
Location	Trials
Japan	129
Canada	126
United Kingdom	95
India	90
China	84

Trials by US State

Trials by US State for Pregabalin
Location	Trials
Florida	73
California	73
Texas	67
New York	62
Ohio	58

Clinical Trial Progress for Pregabalin

Clinical Trial Phase

Clinical Trial Phase for Pregabalin
Clinical Trial Phase	Trials
Phase 4	156
Phase 3	130
Phase 2/Phase 3	20

Clinical Trial Status

Clinical Trial Status for Pregabalin
Clinical Trial Phase	Trials
Completed	314
Recruiting	56
Terminated	49

Clinical Trial Sponsors for Pregabalin

Sponsor Name

Sponsor Name for Pregabalin
Sponsor	Trials
Pfizer	160
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	107
Yuhan Corporation	7

Sponsor Type

Sponsor Type for Pregabalin
Sponsor	Trials
Other	415
Industry	374
NIH	17

Pregabalin: Clinical Trials, Market Analysis, and Projections

Introduction

Pregabalin, a medication widely used for the management of neuropathic pain, epilepsy, and anxiety disorders, has been a subject of extensive clinical trials and market analysis. This article delves into the recent clinical trial updates, market trends, and future projections for pregabalin.

Clinical Trials Update

Efficacy and Decline Effect

Recent meta-epidemiological studies have highlighted a decline in the reported treatment effect of pregabalin over time. A study published in PLOS ONE found that between 2003 and 2020, the treatment effect of pregabalin decreased by 0.4 points on an 11-point pain scale per 5-year interval. This decline, known as the decline effect, suggests that early trials showed stronger treatment effects, particularly for postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN), which were not replicated in later studies[1].

Benefits and Harms

A rapid review and meta-analysis of phase III randomized controlled trials (RCTs) assessed the benefits and harms of pregabalin in managing neuropathic pain. The study found that pregabalin significantly reduced pain and sleep interference compared to placebo, although the evidence was of very low quality. The analysis also highlighted adverse events and discontinuations due to these events as significant concerns[4].

Outcome Measures

Clinical trials have consistently used validated scales to measure pain reduction. For instance, a meta-analysis using numerical rating scales (NRS) showed that pregabalin resulted in a standardized mean difference (SMD) of -0.49 compared to placebo, indicating a statistically significant reduction in pain[4].

Market Analysis

Market Size and Growth

The global pregabalin market is projected to grow significantly over the coming years. As of 2022, the market was valued at $1.6 billion and is expected to reach $2.2 billion by 2032, growing at a compound annual growth rate (CAGR) of 3% from 2023 to 2032[3][5].

Key Growth Drivers

Several factors are driving the growth of the pregabalin market:

• Increasing Prevalence of Neuropathic Pain and Epilepsy: The rising number of people affected by neuropathic pain, epilepsy, and anxiety disorders is a primary growth driver. For example, epilepsy affects over 50 million individuals worldwide, with a significant portion residing in low- and middle-income countries[2][3].
• Generic Approvals: The introduction of generic pregabalin products, such as those approved by the FDA, is expected to drive market growth due to their cost-effectiveness and increased availability[2][5].
• Government Initiatives and Awareness: Government programs aimed at enhancing healthcare accessibility and awareness about epilepsy and neuropathic pain are also contributing to market growth[3][5].

Regional Market Trends

• Asia Pacific: This region is expected to be the fastest-growing market for pregabalin, driven by the large population, increasing healthcare investments, and governmental support for scientific research initiatives[2][3].
• North America: Currently, North America holds the largest market share, primarily due to the high prevalence of neuropathic pain and epilepsy in this region[2][5].

Distribution Channels

The drug store and retail pharmacies segment accounts for the largest share of the global pregabalin market revenue. However, the online providers segment is expected to register the highest CAGR during the forecast period due to convenience, availability, and higher discounts through e-commerce platforms[5].

Market Projections

Future Growth Opportunities

The pregabalin market is anticipated to continue growing, driven by several factors:

• Emerging Markets: The Asia-Pacific region, particularly countries like China, Japan, and India, presents significant growth opportunities due to increasing healthcare investments and a large patient population[3][5].
• New Product Launches: The introduction of new products, including advanced combination drug technologies, is expected to further drive market growth[3].
• Generic Product Approvals: The approval of generic pregabalin products will continue to make the drug more accessible and affordable, contributing to market expansion[2][5].

Challenges and Restraints

Despite the growth potential, the pregabalin market faces several challenges:

• Alternative Therapies: The availability of alternative treatments for neuropathic pain and epilepsy could restrict market growth[2][5].
• Adverse Effects: The adverse effects associated with pregabalin, such as dizziness, somnolence, and discontinuations due to adverse events, remain significant concerns[4].

Key Takeaways

• Declining Treatment Effect: Clinical trials have shown a decline in the treatment effect of pregabalin over time.
• Market Growth: The global pregabalin market is projected to grow at a CAGR of 3% from 2023 to 2032.
• Key Drivers: Increasing prevalence of neuropathic pain and epilepsy, generic approvals, and government initiatives are driving market growth.
• Regional Trends: Asia Pacific is the fastest-growing region, while North America holds the largest market share.
• Distribution Channels: Drug stores and retail pharmacies dominate the market, but online providers are expected to grow rapidly.

FAQs

What is the current market size of the pregabalin market?

The global pregabalin market was valued at $1.6 billion in 2022[3][5].

What is the projected growth rate of the pregabalin market?

The pregabalin market is expected to grow at a CAGR of 3% from 2023 to 2032[3][5].

Which region is expected to be the fastest-growing market for pregabalin?

The Asia Pacific region is expected to be the fastest-growing market for pregabalin[2][3].

What are the primary applications of pregabalin?

Pregabalin is primarily used for the management of neuropathic pain, epilepsy, and anxiety disorders[2][4].

What are the main challenges facing the pregabalin market?

The main challenges include the availability of alternative therapies, adverse effects associated with pregabalin, and stringent regulatory policies[2][5].

Sources

1. PLOS ONE: "A meta-epidemiological study on the reported treatment effect of pregabalin in randomized controlled trials for neuropathic pain in adults."
2. Mordor Intelligence: "Pregabalin Market Size & Share Analysis - Growth Trends."
3. Allied Market Research: "Pregabalin Market Size, Segments Analysis | Forecast - 2032."
4. BMJ Open: "Benefits and harms of pregabalin in the management of neuropathic pain."
5. GlobeNewswire: "Pregabalin Market to Reach $2.2 Billion Globally, By 2032 at 3% CAGR - Allied Market Research."