Evidence map›Paper›PMID 39881115›Full record

ArticleClinical drug investigation2025

Comparison of Pharmacokinetics of Long-Acting Local Analgesics: CPL-01, a Novel Extended-Release Ropivacaine, Demonstrates Consistent and Predictable Exposure Compared with Liposomal Bupivacaine.

Stevie Pope, Christopher Crean, Sarah Thrasher, Hanghang Xu, P J Chen, Lee Chen, DeeDee Hu, Erol Onel

Erratum issued Registry-linked trialAbstract readComparative Study
In one paragraph

Article in Clinical drug investigation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04182880 (Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain After Mini-abdominoplasty Surgery), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04182880 phase2completednot on this map

Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain After Mini-abdominoplasty Surgery

TypeinterventionalSponsorCali Pharmaceuticals LLCRan2020 to 2020Enrolled20ConditionsAbdominoplastyArmsCPL-01, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Trial
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Stevie PopeXyzagen, Inc., Pittsboro, NC, USA.
Christopher CreanXyzagen, Inc., Pittsboro, NC, USA.
Sarah ThrasherXyzagen, Inc., Pittsboro, NC, USA.
Hanghang XuCali (SZ) Biosciences Co., Ltd., Shanghai, China. h.xu@calibiosciences.com.
P J ChenCali Biosciences, US, LLC, San Diego, CA, USA.
Lee ChenCali Biosciences, US, LLC, San Diego, CA, USA.
DeeDee HuSt. David's Medical Center, Austin, TX, USA.
Erol OnelCali Biosciences, US, LLC, San Diego, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThere is a significant medical need for improved long-acting local anesthetics to decrease postsurgical pain and reduce postoperative opioid use. While ropivacaine is considered a safer local anesthetic than bupivacaine, no long-acting ropivacaine formulation is currently marketed. Available formulations of bupivacaine show inconsistent pharmacokinetics (PK) among different surgical models, and inconsistency in PK may lead to a reluctance to use the medication owing to fear of local anesthetic systemic toxicity (LAST) or unreliable efficacy. CPL-01 is a novel extended-release formulation of ropivacaine. This analysis used existing published literature to compare the PK of CPL-01 and liposomal bupivacaine (LB) across five surgical models.

methodsPublished results of LB PK were used to construct dose-normalized curves in total knee arthroscopy, hemorrhoidectomy, and bunionectomy after a 200 mg dose, which were compared with a 200 mg dose of CPL-01 in abdominoplasty, herniorrhaphy, and bunionectomy.

resultsThe shape of the CPL-01 systemic concentration curves was consistent across multiple surgical models; however, in LB it was not. The median time to peak concentration (T

conclusionsCPL-01 demonstrates a more predictable and consistent release of ropivacaine over time, in contrast to LB's erratic and biphasic release of bupivacaine. If approved, the predictability of CPL-01 PK may give physicians greater confidence in more consistent efficacy and less fear of inadvertent LAST.

Indexed as

AmidesAnesthetics, LocalBupivacaineRopivacaineDelayed-Action PreparationsDose-Response Relationship, DrugHumansLiposomesPostoperative PainAmidesAnesthetics, LocalBupivacaineDelayed-Action PreparationsLiposomesRopivacaine

Identifiers

PMID39881115
PMCPMC11802670

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Registered trials

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