- |||||||||| DepoDur (morphine liposomal) / Pacira, Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics, Exparel (bupivacaine liposome injectable suspension) / Pacira
Review, Journal: Nanotechnology for Pain Management. (Pubmed Central) - May 11, 2024
Enrolling by invitation --> Completed | N=98 --> 209 This formulation is the base of DepoDur
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Surgery: A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401. (clinicaltrials.gov) - Oct 26, 2023
P4, N=90, Active, not recruiting,
Initiation date: Apr 2024 --> Nov 2024 Recruiting --> Active, not recruiting | N=60 --> 90 | Trial completion date: Jun 2022 --> Jun 2024 | Trial primary completion date: Apr 2022 --> Jun 2024
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Enrollment change: Phase 2 Bunionectomy HTX-011 Administration Study (clinicaltrials.gov) - Jun 26, 2023
P2, N=78, Completed,
Recruiting --> Active, not recruiting | N=60 --> 90 | Trial completion date: Jun 2022 --> Jun 2024 | Trial primary completion date: Apr 2022 --> Jun 2024 N=60 --> 78
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Enrollment change, Trial withdrawal: Pediatric Postoperative Analgesia Herniorrhaphy Study (clinicaltrials.gov) - Jun 5, 2023
P2, N=0, Withdrawn,
N=60 --> 78 N=336 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Surgery: HTX-011 in Spinal Surgery (clinicaltrials.gov) - Jun 5, 2023
P2, N=32, Completed,
N=336 --> 0 | Not yet recruiting --> Withdrawn Recruiting --> Completed | N=94 --> 32 | Trial completion date: Dec 2022 --> Aug 2022 | Trial primary completion date: Nov 2022 --> Jul 2022
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
New P4 trial: HeronBariatric: ZYNRELEF (clinicaltrials.gov) - May 17, 2023
P4, N=120, Recruiting,
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Enrollment open: ZYNRELEF for Pain Management in Total Knee Arthroplasty (clinicaltrials.gov) - Mar 17, 2023
P4, N=242, Recruiting,
Recruiting --> Completed | N=94 --> 32 | Trial completion date: Dec 2022 --> Aug 2022 | Trial primary completion date: Nov 2022 --> Jul 2022 Not yet recruiting --> Recruiting
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
New P3 trial: Pain Relief After PrimaryTKA (clinicaltrials.gov) - Mar 2, 2023
P3, N=60, Enrolling by invitation,
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Journal: A novel long-acting local anesthetic - HTX-011 (ZYNRELEF™) for postoperative pain control. (Pubmed Central) - Nov 1, 2022
Although multimodal analgesia has been effective in managing postoperative pain, direct surgical infiltration with local anesthetics has had limited efficacy due to their short duration of action. The HTX-011 formulation provides a long-acting local anesthetic at the surgical site which provides a longer period of analgesia while maintaining a favorable safety profile.
- |||||||||| meloxicam / Generic mfg.
Combination of a single block and an extended release formulation of bupivacaine and meloxicam (Poster eBoard 2) - Jun 17, 2022 - Abstract #Euroanaesthesia2022Euroanaesthesia_1172;
To our knowledge, this case report represents the first report on the safety of the combination of a single nerve block and the concomitant use of ERFBN.Conclusion Our data suggest that the combination of a single nerve block performed for postoperative analgesia can be safely combined with ERFBM to provide effective postoperative analgesia in patients undergoing an open unilateral hernia repair. However, additionnal studies are required including pharmacokinetics to confirm these findings
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Journal, Combination therapy: Proposed- HTX-011 in Combination with Multimodal Analgesic Regimen Minimized Severe Pain and Opioid Use after Total Knee Arthroplasty in an Open-Label Study. (Pubmed Central) - Jun 11, 2022
P3b
All patients received intraoperative HTX-011 (400 mg bupivacaine/12 mg meloxicam) in combination with an MMA regimen consisting of preoperative acetaminophen, celecoxib, and pregabalin and postoperative acetaminophen and celecoxib until discharge...Mean total opioid consumption was low over 72 hours: 24.8 morphine milligram equivalents (1-2 tablets of oxycodone 10 mg/day)...The treatment regimen was well tolerated, and no added risk was observed with the addition of MMA. HTX-011 with an MMA regimen reduced postoperative pain and opioid use following TKA.
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Trial completion date, Trial primary completion date: Pediatric Postoperative Analgesia Herniorrhaphy Study (clinicaltrials.gov) - May 18, 2022
P2, N=336, Not yet recruiting,
HTX-011 with an MMA regimen reduced postoperative pain and opioid use following TKA. Trial completion date: Dec 2021 --> Dec 2025 | Trial primary completion date: Oct 2021 --> Nov 2025
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Trial initiation date, Surgery: HTX-011 in Spinal Surgery (clinicaltrials.gov) - Apr 27, 2022
P2, N=94, Recruiting,
Trial completion date: Dec 2021 --> Dec 2025 | Trial primary completion date: Oct 2021 --> Nov 2025 Initiation date: Jun 2021 --> Apr 2022
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics, Tectin (tetrodotoxin) / WEX Pharma, Exparel (bupivacaine liposome injectable suspension) / Pacira
Review, Journal: Novel Local Anesthetics in Clinical Practice: Pharmacologic Considerations and Potential Roles for the Future. (Pubmed Central) - Apr 19, 2022
Tetrodotoxin, a naturally occurring reversible site 1 sodium channel toxin derived from pufferfish and shellfish, has shown the potential to block conduction of isolated nerves...This field is still currently in development, and more researchers will need to be done to ensure the efficacy and safety of these novel formulations. These formulations could be the future of pain management if ongoing research continues to prove positive effects and low side effect profiles.
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Trial completion, Trial completion date, Trial primary completion date: HTX-011 Administration Study in Planned Caesarean Section Procedure (clinicaltrials.gov) - Mar 14, 2022
P2, N=25, Completed,
These formulations could be the future of pain management if ongoing research continues to prove positive effects and low side effect profiles. Recruiting --> Completed | Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Feb 2021 --> Dec 2021
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Journal: Bupivacaine/meloxicam (Zynrelef) for postsurgical pain. (Pubmed Central) - Feb 23, 2022
Recruiting --> Completed | Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Feb 2021 --> Dec 2021 No abstract available
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Herniorrhaphy Study for Opioid Elimination (clinicaltrials.gov) - Feb 21, 2022
P3b, N=115, Completed,
No abstract available Recruiting --> Completed | N=470 --> 115 | Trial completion date: Jul 2021 --> Nov 2021 | Trial primary completion date: Jul 2021 --> Oct 2021
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Enrollment open, Surgery: HTX-011 in Spinal Surgery (clinicaltrials.gov) - Jan 6, 2022
P2, N=90, Recruiting,
Trial completion date: Jan 2025 --> Jan 2024 Not yet recruiting --> Recruiting
- |||||||||| meloxicam / Generic mfg.
Review, Journal: Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain. (Pubmed Central) - Dec 16, 2021
Bupivacaine/meloxicam PR was generally well tolerated, with a lower incidence of opioid-related adverse events than bupivacaine HCl and placebo. Although additional data would be beneficial, current evidence indicates that bupivacaine/meloxicam PR is a promising non-opioid treatment option for the management of postoperative pain.
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Clinical, Journal: HTX-011 (bupivacaine and meloxicam) for the prevention of postoperative pain - clinical considerations. (Pubmed Central) - Oct 30, 2021
Introducing low-dose meloxicam addresses the limited efficacy of liposomal bupivacaine in acidic inflamed tissues and allows enhanced analgesic effects over three days. It has great promise to be an extremely effective postoperative pain regimen and produce an opioid-free surgical recovery, as it has consistently significantly reduced pain scores and opioid consumption through 72 h. This manuscript provides an updated, concise narrative review of the pharmacology, clinical efficacy, safety and tolerability of this drug and its applications to prevent postoperative pain.
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Journal: Opioid-Free Recovery from Bunionectomy with HTX-011, a Dual-Acting Local Anesthetic Combining Bupivacaine and Meloxicam, as the Foundation of Non-Opioid Multimodal Analgesia. (Pubmed Central) - Jul 30, 2021
It has great promise to be an extremely effective postoperative pain regimen and produce an opioid-free surgical recovery, as it has consistently significantly reduced pain scores and opioid consumption through 72 h. This manuscript provides an updated, concise narrative review of the pharmacology, clinical efficacy, safety and tolerability of this drug and its applications to prevent postoperative pain. HTX-011 as the foundation of an MMA regimen including scheduled ibuprofen and acetaminophen maintained mean postoperative pain scores in the mild range and enabled opioid-free recovery for 77% of bunionectomy patients through the 28-day recovery period.
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
New P2 trial, Surgery: HTX-011 in Spinal Surgery (clinicaltrials.gov) - Jun 2, 2021
P2, N=84, Not yet recruiting,
- |||||||||| Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Journal: Opioid-free recovery after herniorrhaphy with HTX-011 as the foundation of a multimodal analgesic regimen. (Pubmed Central) - Nov 18, 2020
HTX-011 has a clear advantage in comparison to both placebo and bupivacaine and provides better pain relief and reduces opioid consumption. HTX-011 when used as the foundation of a nonopioid, multimodal analgesia regimen, provided effective and well-tolerated analgesia without the need for opioids in the majority of patients recovering from an open inguinal herniorrhaphy.
|
