CLINICAL TRIALS PROFILE FOR ZYNRELEF KIT

All Clinical Trials for zynrelef kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05863221 ↗	A Phase IV, Open-Label, Randomized, Active-controlled, Single-Center Study of ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy	Recruiting	Heron Therapeutics	Phase 4	2023-05-09	Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio: Group 1: ZYNRELEF® up to 200 mg/ 6mg ( 7ml vial) via instillation at all incision sites in addition to 30 ml of 0.5% Ropivacaine + 10mg dexamethasone. Postoperatively, intermittent IV acetaminophen will be administered as per need till discharge. Group 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge. Primary Objective: To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy. Secondary Objectives: 1. To evaluate additional efficacy parameters, including opioid load, in this study population. 2. To determine the impact of ZYNRELEF® on the cost of pain management. 3. To assess the time taken to resume exercise after discharge. 4. To assess the adverse events reported following the use of ZYNRELEF®.
NCT05863221 ↗	A Phase IV, Open-Label, Randomized, Active-controlled, Single-Center Study of ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy	Recruiting	Dr. Yannis Raftopoulos	Phase 4	2023-05-09	Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio: Group 1: ZYNRELEF® up to 200 mg/ 6mg ( 7ml vial) via instillation at all incision sites in addition to 30 ml of 0.5% Ropivacaine + 10mg dexamethasone. Postoperatively, intermittent IV acetaminophen will be administered as per need till discharge. Group 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge. Primary Objective: To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy. Secondary Objectives: 1. To evaluate additional efficacy parameters, including opioid load, in this study population. 2. To determine the impact of ZYNRELEF® on the cost of pain management. 3. To assess the time taken to resume exercise after discharge. 4. To assess the adverse events reported following the use of ZYNRELEF®.
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.
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.
NCT06109415 ↗	A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.	Completed	Heron Therapeutics	Phase 4	2021-10-20	This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).
NCT05109312 ↗	A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE	Recruiting	Heron Therapeutics	Phase 4	2021-10-18	This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.
NCT06109428 ↗	A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE	Completed	Heron Therapeutics	Phase 4	2021-10-12	This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing abdominoplasty (Cohort 2).

Clinical Trial Conditions for zynrelef kit

Condition Name

Condition Name for zynrelef kit
Intervention	Trials
Postoperative Pain	2
Analgesia	2
Post Operative Pain, Acute	1
Postoperative Opioid Use in Bariatric Surgery	1

Condition MeSH

Condition MeSH for zynrelef kit
Intervention	Trials
Pain, Postoperative	3
Acute Pain	1
Osteoarthritis, Knee	1

Clinical Trial Locations for zynrelef kit

Trials by Country

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Trials by Country for zynrelef kit
Location	Trials
United States	10

Trials by US State

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Trials by US State for zynrelef kit
Location	Trials
Texas	3
Arkansas	2
Utah	1
Oklahoma	1
Massachusetts	1

Clinical Trial Progress for zynrelef kit

Clinical Trial Phase

Clinical Trial Phase for zynrelef kit
Clinical Trial Phase	Trials
Phase 4	6

Clinical Trial Status

Clinical Trial Status for zynrelef kit
Clinical Trial Phase	Trials
Recruiting	2
Completed	2
Not yet recruiting	1

Clinical Trial Sponsors for zynrelef kit

Sponsor Name

Sponsor Name for zynrelef kit
Sponsor	Trials
Heron Therapeutics	4
Mayo Clinic	1
Baptist Health South Florida	1

Sponsor Type

Sponsor Type for zynrelef kit
Sponsor	Trials
Industry	4
Other	3

ZYNRELEF: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to ZYNRELEF

ZYNRELEF, developed by Heron Therapeutics, is a groundbreaking drug designed for postoperative pain management. It is the first and only dual-acting local anesthetic that combines bupivacaine, a local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory drug (NSAID), in a fixed-dose, prolonged-release formulation[3].

Clinical Trials and Efficacy

Phase 3 Clinical Trials

ZYNRELEF has undergone rigorous testing in Phase 3 clinical trials, demonstrating superiority over bupivacaine solution, the current standard of care. These trials showed that ZYNRELEF resulted in lower pain scores, fewer patients experiencing severe pain, and significantly reduced opioid consumption compared to bupivacaine alone[3].

Safety Profile

In clinical trials involving 1,627 patients across 14 studies, ZYNRELEF was generally well tolerated. It had a similar safety profile to placebo and bupivacaine HCl solution, with patients treated with ZYNRELEF experiencing a lower incidence of opioid-related adverse events. The drug was also well tolerated when used concomitantly with other medications such as aspirin, ropivacaine, and acetaminophen[1].

Synergistic Analgesic Effect

Preclinical and Phase 2 clinical trials revealed a synergistic analgesic effect of ZYNRELEF compared to extended-release (ER) bupivacaine and ER meloxicam given alone or in combination. This synergy extends the analgesic efficacy of ZYNRELEF beyond what would be expected from the individual components, providing pain relief for up to 72 hours[5].

Mechanism of Action and Dosage

Mechanism of Action

ZYNRELEF works by releasing bupivacaine and meloxicam over a period of approximately 72 hours after application to the surgical site. Meloxicam helps control tissue inflammation, normalizing the pH and potentiating the effect of bupivacaine, thereby enhancing analgesia[2].

Dosage and Administration

Each mL of ZYNRELEF solution contains 29.25 mg of bupivacaine and 0.88 mg of meloxicam. The maximum total dose recommended is 400 mg/12 mg (about 14 mL) of bupivacaine/meloxicam. ZYNRELEF is approved for soft tissue or periarticular instillation to produce postsurgical analgesia for various surgical procedures, including foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgeries[2][5].

Market Analysis and Projections

Market Forecast

The market for postoperative pain management is expected to grow significantly due to extensive research and increased healthcare spending globally. ZYNRELEF is anticipated to play a crucial role in this market, with forecasted sales data from 2022 to 2032 indicating a substantial market presence. The report by DelveInsight provides a detailed market assessment, including SWOT analysis, analyst views, and a comprehensive overview of market competitors[2].

Initial Launch and Challenges

Despite being slated as a potential blockbuster by Evercore analysts, ZYNRELEF's early launch faced challenges. The drug received FDA approval in May 2021 after overcoming two complete response letters, but its launch was hindered by a more restrictive label than anticipated. As a result, fourth-quarter sales in 2022 were significantly lower than expected, at just $0.8 million compared to the projected $4 million[4].

Market Competition

ZYNRELEF faces competition from other opioid alternatives, notably Pacira Pharmaceuticals’ Exparel. However, analysts believe that ZYNRELEF will find its niche, particularly in smaller surgeries, and complement Exparel in larger procedures. The need for opioid alternatives in pain management presents a large market opportunity for both drugs[4].

Future Market Scenario

The market scenario for postoperative pain is expected to change with the introduction of new therapies and increased healthcare spending. ZYNRELEF, with its unique dual-acting mechanism and extended-release formulation, is poised to capture a significant share of this market. The launch of late-stage emerging therapies in the near future will also impact the market, but ZYNRELEF's demonstrated efficacy and safety profile position it as a strong contender[2].

Regulatory Milestones and Developmental Activities

FDA Approval and Labeling

ZYNRELEF was initially approved by the FDA in May 2021 for postoperative pain management. The approval process was complex, involving two complete response letters before final approval. The drug's labeling includes important safety information and a boxed warning, which can be found on the official ZYNRELEF website[3].

Ongoing Development

Heron Therapeutics continues to work on improving the preparation and administration of ZYNRELEF, addressing feedback from healthcare providers. This includes a recent submission for a prior approval supplement aimed at simplifying the preparation process, which could enhance its adoption and patient access[3].

Key Takeaways

• Clinical Efficacy: ZYNRELEF has demonstrated superiority over bupivacaine solution in Phase 3 trials, reducing pain scores and opioid consumption.
• Safety Profile: The drug is generally well tolerated with a lower incidence of opioid-related adverse events.
• Mechanism of Action: ZYNRELEF combines bupivacaine and meloxicam for extended-release pain relief.
• Market Potential: Despite initial launch challenges, ZYNRELEF is projected to capture a significant market share in postoperative pain management.
• Regulatory and Developmental Activities: Ongoing efforts to improve preparation and administration are expected to enhance patient access and clinician adoption.

FAQs

What is the unique mechanism of action of ZYNRELEF?

ZYNRELEF combines bupivacaine, a local anesthetic, and meloxicam, an NSAID, in a fixed-dose, prolonged-release formulation. Meloxicam helps control tissue inflammation, potentiating the effect of bupivacaine and enhancing analgesia[2].

How does ZYNRELEF compare to other opioid alternatives in the market?

ZYNRELEF has demonstrated superiority over bupivacaine solution and is expected to complement other opioid alternatives like Exparel, particularly in smaller surgeries. It offers a unique dual-acting mechanism and extended-release formulation[3][4].

What are the approved surgical procedures for ZYNRELEF?

ZYNRELEF is approved for soft tissue or periarticular instillation to produce postsurgical analgesia for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures[5].

What are the potential market challenges for ZYNRELEF?

Despite its potential, ZYNRELEF faced initial launch challenges, including lower-than-expected sales and a more restrictive label than anticipated. It also faces competition from other opioid alternatives[4].

How does ZYNRELEF impact opioid consumption in postoperative pain management?

ZYNRELEF has been shown to significantly reduce opioid consumption compared to bupivacaine solution, making it a valuable option in the effort to minimize opioid use in postoperative care[3].

What are the future market projections for ZYNRELEF?

The market forecast indicates significant growth for ZYNRELEF from 2022 to 2032, driven by increasing healthcare spending and the need for effective opioid alternatives. The drug is expected to capture a substantial market share in postoperative pain management[2].

Sources

1. ZYNRELEF.com: Safety - ZYNRELEF.com
2. MarketResearch.com: ZYNRELEF Drug Insight and Market Forecast – 2032
3. Heron Therapeutics: News Release Details - Heron Therapeutics
4. FiercePharma: Heron's opioid alternative Zynrelef, slated for blockbuster status, hits rough patch in Q4
5. ZYNRELEF.com: ZYNRELEF | Synergy and PK/PD