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.

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	13
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	25
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
Phase 4	43
Phase 3	39
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Lyrica Cr
Clinical Trial Phase	Trials
Completed	97
Terminated	19
Recruiting	18

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	131
Industry	116
NIH	8

LYRICA CR: Clinical Trials, Market Analysis, and Future Projections

Last updated: December 31, 2024

Introduction

LYRICA CR, the extended-release formulation of pregabalin, has been a significant player in the pharmaceutical market, particularly in the management of neuropathic pain conditions. This article delves into the clinical trials, market performance, and future projections of LYRICA CR.

Clinical Trials and FDA Approval

LYRICA CR was approved by the U.S. FDA in October 2017 for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and postherpetic neuralgia (PHN)[1][5].

• The approval was based on a randomized placebo-controlled clinical trial involving 801 patients with PHN. This trial demonstrated that 73.6% of patients in the LYRICA CR group achieved at least 50% improvement in pain intensity, compared to 54.6% in the placebo group[1].

Efficacy and Safety

The clinical trials highlighted the efficacy and safety of LYRICA CR. The trials included a six-week single-blind, dose optimization phase followed by a 13-week double-blind phase. Key findings included:

• Pain Reduction: Significant pain reduction was observed, with 73.6% of patients achieving at least 50% improvement in pain intensity[1].
• Adverse Reactions: Common adverse reactions included dizziness, somnolence, and peripheral edema. In controlled clinical trials, 0.8% of LYRICA CR patients withdrew due to peripheral edema during the single-blind phase[4].

Market Performance

Initial Success and Peak Sales

LYRICA, the brand name for pregabalin, has had a robust market presence since its initial approval in 2005. In its first full year on the market in 2006, LYRICA generated sales of about $1.2 billion[2].

Impact of Patent Expiry

The financial performance of LYRICA CR was significantly impacted by the loss of exclusivity for the original LYRICA formulation. In July 2019, Pfizer lost U.S. exclusivity for LYRICA, leading to a decline in revenues for the Upjohn segment of Pfizer. This decline was reflected in Pfizer's financial results, with Upjohn revenues decreasing by 16% operationally in 2019[2].

Global Pregabalin Market Outlook

Market Size and Growth

The global pregabalin market, which includes LYRICA CR, was valued at $1.6 billion in 2022 and is projected to reach $2.2 billion by 2032, growing at a CAGR of 3% from 2023 to 2032. This growth is driven by the increasing prevalence of neuropathic pain, epilepsy, and anxiety, as well as the rise in generic approvals of pregabalin products[2].

Regional Dynamics

• North America: Currently dominates the global pregabalin market due to advanced healthcare infrastructure and substantial investments in R&D.
• Asia-Pacific: Expected to register the fastest CAGR during the forecast period due to rising healthcare expenditures and technological advancements[2].

Distribution Channels

• Drug Stores and Retail Pharmacies: Dominated the market share in terms of revenue in 2022.
• Online Providers: Anticipated to grow at the fastest CAGR during the forecast period[2].

Competitive Landscape

Generic Competition

The approval of generic pregabalin products has increased competition in the market. However, LYRICA CR's extended-release formulation offers the convenience of once-daily dosing, which can be a differentiator in the market[1][2].

Pricing Strategies

Pfizer has faced criticism for price increases, including a 9.4% price hike for LYRICA in January 2016 and another increase in June 2017. These pricing strategies have been a subject of debate, with some advocating for more affordable access to essential medications[2].

Future Projections

Market Expansion

The pregabalin market is expected to grow significantly, driven by the increasing target population suffering from neuropathic pain, epilepsy, and anxiety. Key strategies adopted by market players, such as product launches and expansions into developing and underdeveloped countries, will further boost the market[2].

Technological Advancements

Rapid technological advancements and increased healthcare investments in regions like China, India, and Southeast Asia are expected to contribute to the market's expansion[2].

Challenges and Opportunities

Regulatory Environment

The commercial success of LYRICA CR is subject to regulatory approvals and the assessment of the benefit-risk profile by regulatory authorities in various jurisdictions. The drug's approval and labeling can significantly impact its market availability and potential[1].

Patient Compliance

The once-daily dosing of LYRICA CR can improve patient compliance, which is a critical factor in the management of chronic pain conditions. However, side effects such as dizziness and somnolence may affect patient adherence[4].

Key Takeaways

• FDA Approval: LYRICA CR was approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.
• Market Performance: The drug's success was significant, but revenues declined after the loss of exclusivity for the original LYRICA formulation.
• Financial Trajectory: Pfizer's overall financial performance has been impacted by the decline in Upjohn revenues, but the Biopharma segment has shown strong growth.
• Global Market Outlook: The global pregabalin market is projected to grow at a CAGR of 3% from 2023 to 2032, driven by increasing prevalence of target conditions and generic approvals.
• Regional Dynamics: North America currently dominates the market, but Asia-Pacific is expected to grow at the fastest CAGR.

FAQs

What is LYRICA CR used for?

LYRICA CR is used for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and postherpetic neuralgia (PHN)[1][5].

How does LYRICA CR differ from the original LYRICA?

LYRICA CR is an extended-release formulation, offering the convenience of once-daily dosing compared to the multiple daily doses required for the original LYRICA[1][5].

What are the common side effects of LYRICA CR?

Common side effects include dizziness, somnolence, and peripheral edema. Other side effects may include weight gain, blurred vision, and creatine kinase elevations[4].

How has the loss of exclusivity affected LYRICA CR's market performance?

The loss of exclusivity for the original LYRICA formulation in July 2019 led to a decline in revenues for Pfizer's Upjohn segment, reflecting a 16% operational decrease in 2019[2].

What are the future growth prospects for the global pregabalin market?

The global pregabalin market is projected to grow at a CAGR of 3% from 2023 to 2032, driven by the increasing prevalence of target conditions and the rise in generic approvals[2].

Cited Sources

1. Pfizer Inc. - U.S. FDA Approves LYRICA® CR (pregabalin) Extended-Release Tablets CV[1].
2. DrugPatentWatch - Summary for LYRICA CR[2].
3. FDA - 209501Orig1s000 - accessdata.fda.gov[3].
4. FDA - LYRICA CR - accessdata.fda.gov[4].
5. DailyMed - Label: LYRICA CR- pregabalin tablet, film coated, extended release[5].