An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries

Recruiting at 7 trial locations

Overseen By Head of Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Innocoll

Must not be taking: Opioid analgesics

Disqualifiers: Hypersensitivity, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a bupivacaine implant to manage pain in patients after soft-tissue surgeries. The implant releases medication at the surgery site to numb the area and reduce pain. It aims to help patients who undergo surgeries like hernia repair and tummy tucks. Liposomal bupivacaine has been shown to be effective in managing postoperative pain in various surgeries, including abdominal and plastic surgeries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been using opioid painkillers regularly in the last four weeks.

What data supports the effectiveness of the drug INL-001 (bupivacaine hydrochloride) implant?

Research shows that the INL-001 implant provides prolonged pain relief after surgery, specifically in open inguinal hernia repair, by delivering bupivacaine directly at the surgical site, which helps avoid the risk of accidental injection and extends the duration of pain relief. ^{1 2 3 4 5}

What safety data exists for the INL-001 (bupivacaine hydrochloride) implant?

The INL-001 implant has been studied for safety in surgeries like hernia repair and abdominoplasty. It is designed to provide extended pain relief and reduce the risk of accidental injection, which can happen with traditional bupivacaine use. Studies have shown it to be generally safe for use in humans. ^{1 2 3 6 7}

How does the drug INL-001 differ from other treatments for postsurgical pain?

INL-001 is a bupivacaine HCl collagen-matrix implant that provides extended pain relief directly at the surgical site, unlike traditional bupivacaine injections that offer only short-lived pain relief and carry a risk of accidental injection into the bloodstream. This implant avoids these risks and offers prolonged analgesia, making it a unique option for managing postsurgical pain. ^{1 2 3 8 9}

Research Team

Anne Arriaga

Principal Investigator

Lotus Clinical Research

Eligibility Criteria

Inclusion Criteria

Has a body mass index of 18-35 kg/m2.

Has a planned (nonemergency) open ventral hernia repair, abdominoplasty (with rectus sheath plication, in the opinion of the surgeon), open abdominal hysterectomy, laparoscopic-assisted colectomy, or reduction mammoplasty to be conducted using standard surgical technique under general anesthesia.

Has the ability and willingness to comply with all study procedures including being domiciled for at least 96 hours after surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Inpatient Treatment

Participants undergo surgery and receive the INL-001 implant under general anesthesia, with assessments for safety and efficacy conducted during the inpatient stay.

5 days

Inpatient stay

Outpatient Follow-up

Participants are monitored for safety and effectiveness after treatment, with scheduled assessments at multiple time points.

30 days

Day 7 (telephone), Day 15 (clinic visit), Day 30 (clinic visit)

Treatment Details

Interventions

• INL-001 (bupivacaine hydrochloride) implant

Participant Groups

Group I: INL-001 (bupivacaine hydrochloride) implant Experimental Treatment 1 Intervention

INL-001 (bupivacaine hydrochloride) implant

Who Is Running the Clinical Trial?

Innocoll

Lead Sponsor

Trials

21

Recruited

5,000+

Findings from Research

The bupivacaine implant (XARACOLL) significantly reduced pain intensity in the first 24 hours after abdominoplasty compared to placebo, indicating its efficacy in providing postoperative analgesia.

Patients receiving the bupivacaine implant had a higher percentage of opioid-free patients at 24, 48, and 72 hours post-surgery, suggesting it may help reduce reliance on opioids for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. Beaton, AC., Solanki, D., Salazar, H., et al.[2023]

3% mepivacaine hydrochloride injection provides a quick onset of anesthesia (average 111 seconds) and effective pain relief (pain-free time of 134 minutes), comparable to 2% lidocaine with adrenaline.

The use of 3% mepivacaine showed minimal side effects on the cardiovascular system, with no significant changes in systolic blood pressure compared to lidocaine, indicating its safety for use in patients with and without hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of 3% mepivacaine hydrochloride injection for oral local anesthesia]. Ding, S., Zhu, YQ., Wu, YN., et al.[2019]

In a study involving 823 patients across various surgical settings, liposome bupivacaine demonstrated a lower incidence of adverse events (62%) compared to bupivacaine HCl (75%) and placebo (43%), indicating better tolerability.

Serious adverse events were less common in the liposome bupivacaine group (2.7%) compared to bupivacaine HCl (5.4%), suggesting that liposome bupivacaine may be a safer option for local analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine, a novel local analgesic formulation. Viscusi, ER., Sinatra, R., Onel, E., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of INL-001 (Bupivacaine HCl) Implants Compared with Bupivacaine HCl Infiltration After Open Unilateral Inguinal Hernioplasty. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Bupivacaine HCl Collagen-Matrix Implant (INL-001) in Open Inguinal Hernia Repair: Results from Two Randomized Controlled Trials. [2020]

4. China pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of 3% mepivacaine hydrochloride injection for oral local anesthesia]. [2019]

5. Poland pubmed.ncbi.nlm.nih.gov

A novel ropivacaine-loaded in situ forming implant prolongs the effect of local analgesia in rats. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine, a novel local analgesic formulation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

In vitro and in vivo drug release from a novel in situ forming drug delivery system. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Prolonged nerve block by microencapsulated bupivacaine prevents acute postoperative pain in rats. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacokinetic profile of liposome bupivacaine injection following a single administration at the surgical site. [2022]