ZYNRELEF vial, applicator, and syringe — bupivacaine and meloxicam extended-release solution

Non-Opioid Pain Management

ZYNRELEF

The first and only dual-acting extended-release local anesthetic — combining bupivacaine with low-dose meloxicam for up to 72 hours of postoperative pain relief.

Applied directly to the surgical site via needle-free applicator. No injection. No reconstitution. One application.

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72 hrs
Sustained postoperative pain relief from a single application
3.25×
More likely to be opioid-free at 72 hours vs. placebo
8+
FDA-approved surgical procedure types
38%
Reduction in opioid consumption vs. placebo (hernia repair)

How ZYNRELEF Works

A synergistic dual-mechanism approach to sustained postoperative pain control

Dual-Acting Synergy

ZYNRELEF combines two complementary mechanisms. Bupivacaine blocks voltage-gated sodium channels to prevent pain signal transmission. Low-dose meloxicam reduces surgical site inflammation and normalizes tissue pH — which keeps more bupivacaine molecules in their active, un-ionized form. The result: potentiated analgesia that outlasts either component alone.

Extended-Release Delivery

ZYNRELEF uses a proprietary Biochronomer® polymer matrix that provides controlled, sustained diffusion of both active ingredients over 72 hours. Unlike standard bupivacaine (which lasts 4–8 hours), ZYNRELEF maintains therapeutic levels throughout the critical first three postoperative days — the window when patients are most vulnerable to opioid initiation.

Needle-Free Application

ZYNRELEF is instilled directly into the surgical site using a Luer lock cone-shaped applicator — no needle required. The viscous solution coats affected tissue after final irrigation and suction, prior to wound closure. The entire kit (vial, vented vial spike, syringes, and applicators) is included in each single-dose package.

Clinical Evidence

Proven efficacy across multiple Phase 3 trials with 1,627+ patients studied

EPOCH 1 — Phase 3

Bunionectomy (412 patients)

Randomized, double-blind, controlled trial demonstrating significantly reduced pain intensity and opioid consumption versus bupivacaine HCl. A greater proportion of ZYNRELEF patients remained opioid-free through 72 hours.

[DOI: 10.1136/rapm-2019-100531]

EPOCH 2 — Phase 3

Open Inguinal Hernia Repair

23% reduction in mean pain intensity vs. placebo. 21% reduction vs. bupivacaine HCl. 38% reduction in opioid consumption vs. placebo and 25% reduction vs. bupivacaine HCl.

[DOI: 10.1007/s10029-019-02023-6]

Phase 2b

Total Knee Arthroplasty

38% reduction in pain intensity in first 72 hours vs. placebo. 37% of TKA patients experienced no severe pain through 72 hours. 39% received no opioid discharge prescription and had no callbacks through day 11.

[DOI: 10.1016/j.arth.2020.05.044]

Subgroup Analysis

Elderly Patient Populations

In bunionectomy patients over 65: 58% opioid-free with ZYNRELEF vs. 25% with bupivacaine HCl. In herniorrhaphy patients over 65: 87% opioid-free vs. 64% with bupivacaine HCl. Demonstrates enhanced benefit in populations most vulnerable to opioid side effects.

[DOI: 10.2217/pmt-2021-0043]

Approved Surgical Procedures

FDA-approved for a growing range of soft tissue and orthopedic procedures

Original Approval — May 2021
Bunionectomy

Primary distal first metatarsal osteotomy

Original Approval — May 2021
Open Inguinal Hernia Repair

Unilateral herniorrhaphy with mesh placement

Original Approval — May 2021
Total Knee Arthroplasty

Periarticular instillation for TKA pain management

Expanded — Jan 2024
Cesarean Section

Instillation at the surgical site during C-section

Expanded — Jan 2024
Lumbar Spinal Surgery

Procedures involving 4 or fewer spinal levels

Expanded — Jan 2024
Total Shoulder Arthroplasty

Periarticular application for shoulder replacement

Expanded — Jan 2024
Augmentation Mammoplasty

Breast augmentation surgical pain management

Expanded — Jan 2024
Additional Foot & Ankle

Extended foot and ankle procedure coverage

Dosage & Administration

Available in four vial sizes — each kit includes everything needed for needle-free application

Vial Volume Bupivacaine Meloxicam Typical Use
14 mL 400 mg 12 mg TKA, shoulder arthroplasty, larger surgical fields
10.5 mL 300 mg 9 mg Hernia repair, spinal surgery
7 mL 200 mg 6 mg Bunionectomy, foot/ankle procedures
2.3 mL 60 mg 1.8 mg Smaller surgical fields

Kit Contents

Each single-dose ZYNRELEF kit contains: one ready-to-use vial, vented vial spike, Luer lock syringes, and Luer lock cone-shaped applicators. No reconstitution or mixing required. Applied directly to the surgical site after final irrigation and suction, prior to wound closure.

Why ZYNRELEF?

Addressing the critical gap between surgical pain and opioid dependence

Beyond Standard Bupivacaine

Standard bupivacaine provides 4–8 hours of relief. ZYNRELEF extends that to 72 hours through its dual-acting mechanism — covering the full critical postoperative window when opioid initiation risk is highest.

Opioid-Sparing Outcomes

Patients are 3.25× more likely to remain opioid-free at 72 hours vs. placebo, and 2.39× more likely vs. bupivacaine HCl. In elderly hernia patients, 87% remained completely opioid-free. [DOI]

Simplified Surgical Workflow

No mixing, no reconstitution, no needles. The ready-to-use vial and included applicators integrate seamlessly into the surgical workflow. Apply after final irrigation, before closing — adding minimal time to the procedure.

Growing Label Coverage

From 3 approved procedures in 2021 to 8+ in 2024, ZYNRELEF's expanding label reflects its growing clinical evidence base. As indications expand, more surgical teams can offer patients a non-opioid path to postoperative comfort.

Frequently Asked Questions

What is ZYNRELEF?

ZYNRELEF is the first and only dual-acting extended-release local anesthetic. It combines bupivacaine with low-dose meloxicam in a proprietary Biochronomer® polymer to provide up to 72 hours of postoperative pain relief, applied directly to the surgical site via a needle-free applicator.

How is ZYNRELEF different from standard bupivacaine?

Standard bupivacaine provides 4–8 hours of relief. ZYNRELEF's dual-acting formula delivers sustained analgesia for up to 72 hours. The meloxicam component reduces inflammation and normalizes tissue pH, allowing bupivacaine to work more effectively for longer.

Does ZYNRELEF require a nerve block?

No. ZYNRELEF is instilled directly into the surgical site — it is not a nerve block. However, it can be used in combination with a single nerve block when clinically appropriate.

What are the main contraindications?

ZYNRELEF should not be used in patients with known hypersensitivity to amide local anesthetics or NSAIDs, a history of asthma/urticaria with aspirin or NSAIDs, or for obstetrical paracervical block anesthesia or CABG surgery pain. Always refer to the full prescribing information.

Is ZYNRELEF available through Sunspot Medical Group?

Yes. Sunspot Medical Group distributes ZYNRELEF to healthcare providers across Las Cruces, El Paso, Southern New Mexico, and West Texas. Contact our clinical team for product samples, pricing, and ordering information.

Ready to Offer ZYNRELEF at Your Facility?

Connect with our clinical team to learn how ZYNRELEF can help your patients recover with less pain and fewer opioids.

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