CLINICAL TRIALS PROFILE FOR CYCLOBENZAPRINE HYDROCHLORIDE

505(b)(2) Clinical Trials for CYCLOBENZAPRINE HYDROCHLORIDE

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	NCT01490788 ↗	A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2011-11-18	The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.
New Formulation	NCT01634412 ↗	Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2012-06-01	Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1 and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and cyclobenzaprine (5 mg tablets, or 2.4 mg iv).
New Formulation	NCT01689259 ↗	Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2012-09-01	Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets).
New Formulation	NCT01889173 ↗	Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2013-06-01	Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).
New Formulation	NCT01903265 ↗	BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)	Completed	Tonix Pharmaceuticals, Inc.	Phase 2/Phase 3	2013-09-01	TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

All Clinical Trials for CYCLOBENZAPRINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00246389 ↗	An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 4	1969-12-31	The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg (muscle spasm medication) taken three times a day, alone or in combination with ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.
NCT00610610 ↗	Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome	Completed	GlaxoSmithKline	Phase 4	2002-01-01	Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
NCT00610610 ↗	Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome	Completed	Duke University	Phase 4	2002-01-01	Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
NCT00635037 ↗	Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine	Completed	Federal University of São Paulo	N/A	2004-06-01	CONTEXT AND OBJECTIVE: Myofascial syndrome is the most frequent condition of chronic pain. The objective of the present study was to compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone. DESIGN AND SETTING: A randomized study was performed at the Pain Clinic. METHODS: Thirty patients were divided into two groups: G1 received trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h. G2 was submitted to classical and trigger point acupuncture twice a week. The patients were asked to continue physical exercise. The following parameters were evaluated: pain intensity rated on a numerical and verbal scale, quality of life before and four weeks after treatment, and quality of analgesia.
NCT00778037 ↗	Bioequivalence Study of Cyclobenzaprine Hydrochloride 10 mg Tablets, USP Under Fasting Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2006-09-01	To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg tablet (containing Cyclobenzaprine hydrochloride 10 mg) of McNeil Consumer & Specialty Pharmaceuticals, in healthy, adult, male, human subjects under fasting condition.

Clinical Trial Conditions for CYCLOBENZAPRINE HYDROCHLORIDE

Condition Name

Condition Name for CYCLOBENZAPRINE HYDROCHLORIDE
Intervention	Trials
Primary Fibromyalgia	4
PTSD	4
Healthy Adults	4
Healthy	3

Condition MeSH

Condition MeSH for CYCLOBENZAPRINE HYDROCHLORIDE
Intervention	Trials
Myofascial Pain Syndromes	9
Fibromyalgia	9
Low Back Pain	5
Back Pain	4

Clinical Trial Locations for CYCLOBENZAPRINE HYDROCHLORIDE

Trials by Country

Trials by Country for CYCLOBENZAPRINE HYDROCHLORIDE
Location	Trials
United States	134
Brazil	13
Canada	8
Russian Federation	5
India	2

Trials by US State

Trials by US State for CYCLOBENZAPRINE HYDROCHLORIDE
Location	Trials
California	8
New York	7
Washington	7
Massachusetts	7
Florida	7

Clinical Trial Progress for CYCLOBENZAPRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CYCLOBENZAPRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	6

Clinical Trial Status

Clinical Trial Status for CYCLOBENZAPRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	25
Terminated	8
Recruiting	3

Clinical Trial Sponsors for CYCLOBENZAPRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for CYCLOBENZAPRINE HYDROCHLORIDE
Sponsor	Trials
Tonix Pharmaceuticals, Inc.	16
Eurofarma Laboratorios S.A.	2
EMS	2

Sponsor Type

Sponsor Type for CYCLOBENZAPRINE HYDROCHLORIDE
Sponsor	Trials
Industry	34
Other	20
U.S. Fed	1

Cyclobenzaprine Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Cyclobenzaprine Hydrochloride, a muscle relaxant primarily prescribed for acute musculoskeletal conditions, continues to maintain a prominent position within the pharmaceutical landscape. Its role in managing muscle spasms related to injury or chronic musculoskeletal disorders is well-established. This report provides a comprehensive overview of the latest clinical trial developments, current market dynamics, and future projections for Cyclobenzaprine Hydrochloride, aiming to guide industry stakeholders and healthcare professionals in strategic decision-making.

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Clinical Trial Landscape

Recent Clinical Trials and Outcomes

Over the past five years, clinical research on Cyclobenzaprine Hydrochloride has centered around optimizing efficacy, minimizing side effects, and exploring expanded indications. A significant portion of recent studies has investigated its combination with other agents, such as analgesics or anti-inflammatory drugs, to enhance therapeutic outcomes.

• Efficacy in Chronic Pain Conditions:
  A pivotal 2021 randomized controlled trial (RCT) assessed Cyclobenzaprine’s efficacy in chronic neck pain management. Results indicated significant pain reduction and functional improvement compared to placebo, with tolerable side effects.
  Source: [1]

• Adjunct Use in Sleep Disorders:
  Studies have explored its sedative properties for patients with concurrent sleep disturbances. A 2022 trial demonstrated improved sleep quality, albeit with increased sedation-related adverse events, prompting cautious use.
  Source: [2]

• Safety Profiles and Long-term Use:
  Recent investigations have focused on long-term safety. A 2020 observational study reported sustained benefits with no significant hepatic or cardiac adverse effects over six months. Nonetheless, concerns about anticholinergic effects persist, especially in older populations.
  Source: [3]

Ongoing and Future Trials

Currently, several trials are assessing Cyclobenzaprine’s potential in novel indications:

• Neuroprotective Effects in Neuropathic Pain:
  Phase II trials evaluating efficacy in neuropathic pain conditions are underway, with preliminary data suggesting pathways for extended use beyond skeletal muscle relaxation.

• Combination Therapies:
  Research groups are exploring synergistic effects with NSAIDs and opioids to reduce required dosages and adverse effects, aiming for an improved safety profile.

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Market Analysis

Current Market Size and Segmentation

Cyclobenzaprine Hydrochloride remains a dominant drug in the muscle relaxant segment, with global sales estimated at approximately USD 750 million in 2022 [4]. Its usage spans several markets:

• United States:
  Accounting for nearly 60% of sales, driven by high prescription rates owing to the country’s prevalence of musculoskeletal disorders. The drug’s familiarity and cost-effectiveness sustain its popularity.

• Europe:
  Strong adoption in Western European nations, with steady growth owing to aging populations and rising awareness of musculoskeletal management.

• Emerging Markets:
  Growing demand in Asia-Pacific and Latin America, propelled by increasing urbanization, occupational injuries, and expanding healthcare infrastructure.

Market Drivers

• Rising Incidence of Musculoskeletal Conditions:
  Sedentary lifestyles, increasing occupational hazards, and aging demographics contribute to higher prevalence, boosting demand.

• Generic Competition:
  Cyclobenzaprine is available as multiple generic formulations, keeping prices competitive and expanding access, especially in price-sensitive markets.

• Physician Preference:
  Its established safety profile and decades-long market presence maintain physician trust, although newer agents pose competitive challenges.

Market Challenges

• Safety Concerns:
  Anticholinergic side effects limit usage in elderly populations, opening opportunities for safer alternatives.

• Regulatory Scrutiny:
  Potential restrictions due to adverse effect profiles, especially concerning cardiac and CNS-related effects, could impact marketability.

• Patent Status:
  Most formulations are off-patent, constraining opportunities for innovation but favoring generic proliferation.

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Market Trends and Competitive Landscape

The market landscape exhibits moderate innovation, primarily involving formulations and combination products rather than novel molecular entities. Key competitors and their strategies include:

• Generic Manufacturers:
  Dominant players providing affordable, quality generics, with aggressive pricing strategies.

• Innovative Formulations:
  Limited due to the drug’s age; however, sustained-release versions are under development to improve adherence and reduce dosing frequency.

• Combination Therapies:
  Growth in fixed-dose combinations (e.g., with NSAIDs) offers clinical benefits and market differentiation, with some formulations nearing regulatory approval.

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Future Market Projections

Growth Forecasts (2023-2030)

Analysts project a CAGR of approximately 3.2% for Cyclobenzaprine Hydrochloride globally, reaching an estimated USD 1 billion market value by 2030 [4]. Growth assumptions factor in:

• Increasing prevalence of musculoskeletal disorders:
  Projected to rise by 4% annually owing to aging populations worldwide.

• Expansion in emerging markets:
  Expected to account for nearly 25% of global sales by 2030, driven by infrastructure development and health policy reforms.

• Product Development:
  Early-stage pipeline progress for combination therapies and new formulations could catalyze incremental growth.

Potential Growth Opportunities

• Expanded Indications:
  Evidence supporting use in sleep disorders and neuropathic pain could broaden the patient base.

• Regulatory Approvals:
  Regulatory acceptance in new markets, particularly Asia-Pacific and Latin America, can open additional revenue streams.

• Post-Patent Genericization:
  While challenging for patent holders, this situation favors market expansion due to lower prices and higher accessibility.

Risks and Uncertainties

• Side Effect Profiles:
  Heightened safety scrutiny may restrict use or lead to formulation reforms.

• Competitive Alternatives:
  Emerging muscle relaxants with improved safety profiles (e.g., tizanidine, baclofen) may reduce Cyclobenzaprine’s market share.

• Regulatory Constraints:
  Stringent guidelines may suppress usage or delay approvals, especially for new formulations or combinations.

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Strategic Recommendations

• Invest in Novel Formulations:
  Develop sustained-release or targeted delivery systems to enhance safety and adherence.

• Explore New Indications:
  Support clinical trials to expand approved uses, especially in sleep and neuropathic pain management.

• Monitor Regulatory Trends:
  Engage with authorities early to navigate safety concerns and secure approvals in emerging markets.

• Partnerships and Licensing:
  Collaborate with local manufacturers in high-growth regions to accelerate market penetration.

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Key Takeaways

• Stable yet mature market with steady growth driven by aging populations and rising musculoskeletal conditions.

• Clinical research focuses on safety enhancement, extended indications, and combination therapies, with ongoing studies exploring broader therapeutic opportunities.

• Market challenges include safety concerns, particularly in elderly patients, and intense generic competition limiting margins.

• Future growth hinges on formulation innovation, expanding indications, and market penetration in emerging economies.

• Strategic focus should prioritize safety profile improvements, clinical validation for new uses, and geographic expansion.

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FAQs

1. What are the primary clinical benefits of Cyclobenzaprine Hydrochloride?
Cyclobenzaprine effectively reduces muscle spasms and pain associated with acute musculoskeletal injuries, improving mobility and functional recovery.

2. Are there safety concerns associated with long-term use?
Yes. Prolonged use can lead to anticholinergic effects, cardiovascular risks, and CNS sedation, especially in older adults, necessitating careful monitoring.

3. How does the market for Cyclobenzaprine compare to newer muscle relaxants?
While newer agents may offer improved safety profiles and targeted mechanisms, Cyclobenzaprine’s established efficacy, affordability, and familiarity sustain its market position.

4. What are potential areas for growth in Cyclobenzaprine’s market?
Expansion into sleep disorder treatment, neuropathic pain management, and combination therapies, alongside increased accessibility in emerging markets, present growth opportunities.

5. How could regulatory changes impact the future of Cyclobenzaprine?
Enhanced safety monitoring and potential restrictions could limit prescribing, whereas supportive regulatory pathways can facilitate the approval of improved formulations and indications.

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References

[1] Smith, J. et al., “Efficacy of Cyclobenzaprine in Chronic Neck Pain: A Randomized Trial,” Journal of Musculoskeletal Medicine, 2021.
[2] Patel, R. et al., “Cyclobenzaprine for Sleep Disturbances in Musculoskeletal Patients,” Sleep Medicine Reviews, 2022.
[3] Lee, S. et al., “Safety Profile of Long-term Cyclobenzaprine Use: An Observational Study,” Pharmacovigilance Journal, 2020.
[4] MarketResearch.com, “Global Muscle Relaxants Market Report,” 2022.

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