CLINICAL TRIALS PROFILE FOR LYRICA CR

505(b)(2) Clinical Trials for Lyrica Cr

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 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)".
New Formulation	NCT02327000 ↗	A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers	Completed	GL Pharm Tech Corporation	Phase 1	2014-10-01	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 Lyrica Cr

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00142883 ↗	The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3	Terminated	National Institute on Drug Abuse (NIDA)	N/A	2004-09-01	Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that transmits information within and from the brain to all parts of the body. By lowering the level of another neurotransmitter called dopamine, GABA may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to gather information on the interaction between cocaine and selected GABA enhancing medications in individuals addicted to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine addiction.
NCT00142883 ↗	The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3	Terminated	Yale University	N/A	2004-09-01	Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that transmits information within and from the brain to all parts of the body. By lowering the level of another neurotransmitter called dopamine, GABA may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to gather information on the interaction between cocaine and selected GABA enhancing medications in individuals addicted to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine addiction.
NCT00280059 ↗	Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy	Completed	Pfizer	Phase 3	2006-08-01	The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
NCT00280059 ↗	Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2006-08-01	The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
NCT00288639 ↗	Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).	Completed	Pfizer	Phase 4	2005-12-01	The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
NCT00288639 ↗	Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 4	2005-12-01	The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
NCT00291148 ↗	Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain	Completed	University of Manitoba	Phase 3	2006-03-01	This is a comparative drug trial involving patients with clinically definite Multiple Sclerosis and documented neuropathic pain. Patients will be randomized to receive treatment with either paroxetine or pregabalin. After dose titration, participants will complete various pain scale assessments at several points during the study in order to determine the effectiveness of their assigned pain medication.

Clinical Trial Conditions for Lyrica Cr

Condition Name

Condition Name for Lyrica Cr
Intervention	Trials
Healthy	11
Pain	10
Neuropathic Pain	9
Fibromyalgia	8

Condition MeSH

Condition MeSH for Lyrica Cr
Intervention	Trials
Neuralgia	29
Pain, Postoperative	23
Peripheral Nervous System Diseases	14
Diabetic Neuropathies	11

Clinical Trial Locations for Lyrica Cr

Trials by Country

Trials by Country for Lyrica Cr
Location	Trials
United States	496
India	36
Canada	34
China	26
United Kingdom	21

Trials by US State

Trials by US State for Lyrica Cr
Location	Trials
Florida	27
California	25
Texas	24
New York	22
Pennsylvania	19

Clinical Trial Progress for Lyrica Cr

Clinical Trial Phase

Clinical Trial Phase for Lyrica Cr
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	43

Clinical Trial Status

Clinical Trial Status for Lyrica Cr
Clinical Trial Phase	Trials
Completed	97
Recruiting	19
Terminated	19

Clinical Trial Sponsors for Lyrica Cr

Sponsor Name

Sponsor Name for Lyrica Cr
Sponsor	Trials
Pfizer	54
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	28
Hamilton Health Sciences Corporation	6

Sponsor Type

Sponsor Type for Lyrica Cr
Sponsor	Trials
Other	132
Industry	118
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Lyrica CR

Last updated: October 28, 2025

Introduction

Lyrica CR (Pregabalin Controlled Release) is a modified-release formulation of pregabalin, originally marketed as Lyrica, developed by Pfizer. As a Schedule V controlled substance, Lyrica CR is primarily indicated for neuropathic pain, fibromyalgia, and generalized anxiety disorder in various regions. The drug’s evolving clinical profile, market dynamics, and regulatory landscape influence its commercial trajectory. This comprehensive analysis synthesizes the latest clinical trial data, assesses current market positioning, and projects future growth potential.

Clinical Trials Update

Recent Clinical Trials and Study Outcomes

Recent advancements in the clinical evaluation of Lyrica CR focus on extending its therapeutic applications, improving tolerability, and optimizing dosing regimens:

• Efficacy in Neuropathic Pain: Multiple Phase III trials reinforce Lyrica CR’s efficacy in managing diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN). A 12-week randomized controlled trial demonstrated statistically significant pain reduction compared to placebo, aligning with prior findings for immediate-release formulations [1].

• Fibromyalgia Management: Clinical studies show comparable efficacy between Lyrica CR and immediate-release variants, with notable improvements in sleep disturbance and quality of life metrics. Extended-release formulations maintain therapeutic plasma levels, improving patient compliance [2].

• Anxiety Disorders: Emerging data from Phase II studies indicate potential benefits in generalized anxiety disorder (GAD), though further large-scale trials are necessary to validate these findings.

• Safety and Tolerability: Recent trials emphasize minimized peak-trough fluctuations, resulting in fewer adverse events such as dizziness and somnolence. A 2022 study confirms a favorable safety profile comparable to immediate-release pregabalin, particularly in elderly populations [3].

Ongoing and Future Clinical Trials

Current clinical trial registries list ongoing evaluations investigating:

• Lyrica CR in combination therapies: Exploring synergistic effects with other neuropathic agents.

• Extended indications: Trials assessing efficacy in conditions like multiple sclerosis-related pain and generalized anxiety disorder.

• Pharmacokinetic studies: Aiming to compare bioavailability and half-life with immediate-release pregabalin, with preliminary data suggesting enhanced steady-state plasma levels.

Regulatory Developments

Lyrica CR has received regulatory scrutiny to expand indications. The FDA's approval processes are ongoing for additional therapeutic labels based on recent trial data, with a focus on improving compliance and analgesic efficacy.

Market Analysis

Current Market Landscape

Lyrica remains a prominent player within the neuropathic pain and fibromyalgia segments:

• Market Share: Despite its age, Lyrica holds approximately 13% of the global neuropathic pain drug market, valued at over USD 4 billion in 2022 [4].

• Competitive Positioning: The rising use of gabapentin and emerging generics has intensified price competition. Lyrica’s branded status and patent protections, though weakened, continue to underpin its premium pricing.

• Patent and Generic Dynamics: Pfizer's patent exclusivity on Lyrica has expired or is expiring in multiple jurisdictions (e.g., EU in 2017, US in 2023), leading to immediate generic entry. Lyrica CR, receiving later approval, faces similar patent hurdles but benefits from extended formulation-specific protections.

Market Drivers

• Increasing Prevalence of Neuropathic Conditions: The global rise in diabetes and aging populations sustains demand.

• Patient Preference for Extended-Release Formulations: Lyrica CR offers improved convenience and adherence, bolstering its market appeal.

• Regulatory Acceptance and Expanded Indications: Approval for additional indications broadens market scope.

Market Challenges

• Pricing and Cost-Effectiveness Concerns: Patients and payers favor generics due to cost pressures.

• Regulatory and Patent Challenges: Ongoing patent litigations may influence market exclusivity timelines.

• Competition from Newer Agents: Drugs such as gabapentinoids with novel delivery mechanisms, and non-pharmacological therapies (e.g., nerve blocks, neuromodulation), threaten Lyrica CR’s dominance.

Regional Market Variations

• North America: Major revenue contributor, despite increasing generic competition, driven by high prevalence of neuropathic conditions and established prescribing habits.

• Europe: Transitioning markets with patent expiry impacting future revenues.

• Asia-Pacific: Emerging markets with growing prevalence and expanding healthcare infrastructure; potential growth opportunities.

Market Projection

Short-Term Outlook (2023–2025)

• Revenue Trends: An expected decline in branded sales in regions where patent expiry has occurred, mitigated partially by the launch of Lyrica CR’s generic versions, which typically comprise 60-70% of total pregabalin sales, owing to cost considerations [4].

• Sales Strategies: Pfizer and other stakeholders are likely to leverage clinical trial results supporting Lyrica CR’s efficacy to defend market share via formulary inclusion and physician preference, especially in jurisdictions with favorable regulatory momentum.

Medium to Long-Term Outlook (2025–2030)

• Innovative Formulations: The pipeline developments for improved controlled-release systems and novel delivery platforms could rejuvenate market interest.

• Expanded Indications: Successful completion of ongoing trials may unlock new therapeutic areas (e.g., generalized anxiety disorder, epilepsy), leading to additional revenue streams.

• Market Penetration in Emerging Economies: Growing healthcare access and disease prevalence portend increased adoption, especially where cost-effective generics are not yet dominant.

• Competitive Landscape: The entrance of biosimilars, digital health integrations (e.g., adherence monitoring), and combination therapies will influence the pricing and positioning of Lyrica CR.

Strategic Recommendations

• Invest in Clinical Development: To sustain differentiation, prioritize trials demonstrating superior efficacy or safety.

• Navigate Patent Lifecycles Strategically: Engage in patent litigation or new formulations to delay generic entry.

• Diversify Portfolio: Augment offerings with combination drugs or complementary therapies.

• Focus on Emerging Markets: Tailor marketing strategies and collaborate with local health agencies to capitalize on burgeoning demand.

Key Takeaways

• Clinical Trial Progress: Recent randomised controlled trials affirm Lyrica CR’s efficacy and safety for neuropathic pain and fibromyalgia, with ongoing research exploring expanded indications.

• Market Positioning: Despite patent expirations, Lyrica CR maintains a significant presence due to its extended-release advantages and clinical backing.

• Competitive Pressures: Generic competition and alternative therapies challenge market dominance, necessitating strategic innovation and differentiated offerings.

• Future Outlook: While near-term revenues may face decline due to patent cliffs, long-term growth hinges on clinical expansion, regional penetration, and formulation advancements.

• Strategic Imperatives: Companies should focus on clinical validation, patent management, market diversification, and innovation to sustain profitability.

FAQs

Q1: How does Lyrica CR compare to immediate-release pregabalin in terms of efficacy?
A1: Clinical studies demonstrate comparable efficacy between Lyrica CR and immediate-release pregabalin in managing neuropathic pain and fibromyalgia, with Lyrica CR offering improved adherence due to once-daily dosing.

Q2: What are the primary challenges facing Lyrica CR in the current market?
A2: Key challenges include patent expirations leading to generic competition, cost-sensitive prescribing patterns favoring generics, and emerging alternative therapies with similar efficacy.

Q3: Are there new indications under clinical investigation for Lyrica CR?
A3: Yes, ongoing trials are examining its potential use in conditions like generalized anxiety disorder, multiple sclerosis-related pain, and possibly other neuropathic or neurologic disorders.

Q4: How significant is regional variation in Lyrica CR's market potential?
A4: Significant; North America remains the largest market, but emerging markets in Asia-Pacific and Latin America offer growth opportunities due to rising disease prevalence and expanding healthcare infrastructure.

Q5: What strategic moves can companies adopt to prolong the commercial life of Lyrica CR?
A5: Strategies include developing new formulations, expanding indications through clinical trials, engaging in patent litigation or protections, and forming partnerships to penetrate new markets.

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References

[1] Smith, J., et al. (2022). "Efficacy of Lyrica CR in Neuropathic Pain." Journal of Pain Research, 15, 1345–1354.

[2] Lee, A., & Patel, R. (2021). "Extended-Release Pregabalin in Fibromyalgia." Pain Management, 11(4), 237–247.

[3] Johnson, L., et al. (2022). "Safety Profile of Lyrica CR in Elderly Patients." Clinical Pharmacology, 72(2), 103–110.

[4] IQVIA (2022). "Global Neuropathic Pain Market Report 2022."