CLINICAL TRIALS PROFILE FOR BUPIVACAINE; MELOXICAM

All Clinical Trials for Bupivacaine; Meloxicam

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01546857 ↗	Effect of Gabapentin on Orthopedic Pain	Terminated	Rutgers, The State University of New Jersey	Phase 4	2012-03-01	This study is being done to determine if a drug called gabapentin helps in the postoperative management of patients undergoing hip and knee operations. The investigators wish to determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a patient's pain and improve sleep, the patient will be better able to participate in their physical therapy. Gabapentin has already been shown to lessen postoperative pain when given before surgery. In healthy patients, it has also been shown to improve certain aspects of sleep. We hope to identify the effect of the drug, when given after surgery, on patients' pain and sleep.
NCT04538391 ↗	Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief	Completed	Menoufia University	N/A	2019-03-03	Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement. Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable
NCT05188053 ↗	Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty	Enrolling by invitation	Mayo Clinic	Phase 4	2022-01-01	The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.
NCT05644496 ↗	ZYNRELEF for Pain Management in Total Knee Arthroplasty	Not yet recruiting	Baptist Health South Florida	Phase 4	2023-01-01	The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement. The main questions it aims to answer are: - How well does the study drug control pain in the days after surgery? - Does the study drug reduce the amount of opioid analgesic consumed after surgery? Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam). Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.
NCT05702827 ↗	Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery	Not yet recruiting	TriHealth Inc.	Phase 3	2023-01-01	This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.

Clinical Trial Conditions for Bupivacaine; Meloxicam

Condition Name

Condition Name for Bupivacaine; Meloxicam
Intervention	Trials
Stress Urinary Incontinence	1
Surgical Incision	1
Total Knee Arthroplasty	1
Cesarean Section Pain	1

Condition MeSH

Condition MeSH for Bupivacaine; Meloxicam
Intervention	Trials
Pain, Postoperative	3
Osteoarthritis, Hip	1
Osteoarthritis	1
Urinary Incontinence, Stress	1

Clinical Trial Locations for Bupivacaine; Meloxicam

Trials by Country

Trials by Country for Bupivacaine; Meloxicam
Location	Trials
United States	5
Egypt	1

Trials by US State

Trials by US State for Bupivacaine; Meloxicam
Location	Trials
Pennsylvania	1
Ohio	1
Florida	1
Minnesota	1
New Jersey	1

Clinical Trial Progress for Bupivacaine; Meloxicam

Clinical Trial Phase

Clinical Trial Phase for Bupivacaine; Meloxicam
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
N/A	1

Clinical Trial Status

Clinical Trial Status for Bupivacaine; Meloxicam
Clinical Trial Phase	Trials
Enrolling by invitation	2
Not yet recruiting	2
Terminated	1

Clinical Trial Sponsors for Bupivacaine; Meloxicam

Sponsor Name

Sponsor Name for Bupivacaine; Meloxicam
Sponsor	Trials
Rutgers, The State University of New Jersey	1
Menoufia University	1
Mayo Clinic	1

Sponsor Type

Sponsor Type for Bupivacaine; Meloxicam
Sponsor	Trials
Other	6

Bupivacaine and Meloxicam: A Synergistic Approach to Postoperative Pain Management

Introduction

The combination of bupivacaine and meloxicam, marketed as ZYNRELEF, has revolutionized the field of postoperative pain management. This synergistic extended-release solution has shown significant promise in clinical trials and is poised to make a substantial impact on the market.

Clinical Trials and Efficacy

Synergistic Analgesic Effect

In preclinical and Phase 2 clinical trials, ZYNRELEF demonstrated a synergistic analgesic effect that surpassed the efficacy of bupivacaine and meloxicam when administered separately or in combination without the extended-release formulation[1][3][5].

Extended-Release Formulation

The extended-release formulation allows for the simultaneous diffusion of bupivacaine and meloxicam over 72 hours, providing sustained postoperative pain management. This formulation has been shown to be superior to bupivacaine alone, which typically has an efficacy limited to 8-12 hours despite a 72-hour exposure profile[1][5].

Clinical Trial Outcomes

In Phase 2 and Phase 3 clinical trials, ZYNRELEF was compared to bupivacaine HCl, bupivacaine ER, and meloxicam ER, with and without scheduled non-opioid multimodal analgesia (MMA). These trials, conducted in procedures such as bunionectomies, herniorrhaphies, total knee arthroplasty, and abdominoplasty, showed that ZYNRELEF provided effective analgesia for up to 72 hours with minimal or no opioid use. The solution also demonstrated a similar tolerability profile to bupivacaine HCl and placebo, with a lower incidence of opioid-related adverse events[3][5].

Market Analysis

Market Size and Growth

The meloxicam market, a key component of ZYNRELEF, is anticipated to reach USD 47 billion by 2036, growing at a CAGR of around 5% during the forecast period of 2024-2036. This growth is driven by the increasing prevalence of osteoarthritis, juvenile rheumatoid arthritis, and rheumatoid arthritis, particularly among the older population[2].

Regional Market Dynamics

• North America: Expected to account for the largest revenue share of 33% by the end of the forecast period, driven by an increasing number of arthritis and chronic pain patients, along with advanced healthcare infrastructure and research activities[2].
• Asia Pacific: Projected to account for a notable revenue share due to the growing aging population and increasing incidence of osteoarthritis, rheumatoid arthritis, and other conditions. Favorable reimbursement policies for generic drugs also contribute to this growth[2].

Combination Drug Segment

The combination drug segment, which includes ZYNRELEF, is set to grow significantly. Combination drugs like ZYNRELEF are in high demand due to their ability to treat multiple conditions effectively, making them a preferred choice for managing complex pain scenarios[2].

Market Projections

Expanded Indications

ZYNRELEF has recently received FDA approval for an expanded indication to include additional orthopedic and soft tissue procedures, such as cesarean sections, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. This expansion is expected to cover approximately 13 million procedures annually, representing an 86% increase over prior indicated procedures[4].

Impact on Patient Care

The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across a wider range of surgical procedures. This is particularly significant given the current opioid crisis, as ZYNRELEF has been shown to reduce or eliminate postoperative opioid consumption[4].

Safety and Tolerability

Adverse Effects

Clinical trials have shown that ZYNRELEF is generally well tolerated, with adverse effects similar to those of bupivacaine HCl and placebo. Common adverse effects include nausea, dizziness, constipation, and headaches. There were no unique safety issues identified in the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience[3][4][5].

Relevance to Patient Care and Clinical Practice

Opioid-Sparing Effects

ZYNRELEF is a viable, safe, non-opioid local anesthetic for sustained 72-hour postoperative pain management, mitigating opioid consumption. This is crucial in the current healthcare landscape, where reducing opioid use is a priority to prevent opioid-related adverse events and addiction[3][5].

Wound Healing

The use of ZYNRELEF has not been shown to impact wound healing, which is an important consideration in postoperative care. This ensures that patients can benefit from effective pain management without compromising their recovery[3].

Key Takeaways

• Synergistic Efficacy: ZYNRELEF exhibits a synergistic analgesic effect that is superior to bupivacaine and meloxicam administered separately.
• Extended-Release Formulation: Provides sustained pain management for up to 72 hours.
• Market Growth: The meloxicam market is projected to grow significantly, driven by increasing prevalence of arthritis and other chronic pain conditions.
• Expanded Indications: ZYNRELEF’s expanded FDA approval covers a broader range of surgical procedures.
• Safety and Tolerability: Generally well tolerated with a lower incidence of opioid-related adverse events.
• Opioid-Sparing Effects: Reduces or eliminates postoperative opioid consumption.

FAQs

What is ZYNRELEF?

ZYNRELEF is an extended-release solution combining bupivacaine and meloxicam, approved for postoperative pain management.

How does ZYNRELEF work?

ZYNRELEF works by simultaneously releasing bupivacaine and meloxicam over 72 hours, providing sustained analgesia and reducing inflammation at the surgical site.

What are the benefits of using ZYNRELEF?

ZYNRELEF offers effective pain management for up to 72 hours, reduces opioid consumption, and is generally well tolerated with a similar adverse effect profile to bupivacaine HCl and placebo.

What procedures is ZYNRELEF approved for?

ZYNRELEF is approved for various surgical procedures including foot and ankle, small-to-medium open abdominal, lower extremity total joint arthroplasty, cesarean sections, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty.

How does ZYNRELEF impact opioid use?

ZYNRELEF significantly reduces or eliminates postoperative opioid consumption, which is crucial in the effort to minimize opioid-related adverse events and addiction.

Sources

1. ZYNRELEF | Synergy and PK/PD. Zynrelef.com.
2. Meloxicam Market Size - Global Forecast Report 2036. Research Nester.
3. Bupivacaine/meloxicam ER: A New Dual-acting Extended ... - PubMed. PubMed.
4. Heron Therapeutics Announces FDA Approval of ZYNRELEF .... Heron Therapeutics.
5. Bupivacaine/Meloxicam Prolonged Release: A Review in ... - PubMed. PubMed.