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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called the INL-001 implant, which slowly releases the pain-relieving medication bupivacaine after surgery. The goal is to assess the safety and effectiveness of this implant in reducing pain for individuals undergoing surgeries such as hernia repair, tummy tuck, hysterectomy, colon surgery, or breast reduction. Individuals planning one of these surgeries and willing to use pain medication afterward might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking pain management solution.

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 prior data suggests that the INL-001 (bupivacaine hydrochloride) implant is safe for soft-tissue surgeries?

Research has shown that the INL-001 implant, containing bupivacaine hydrochloride, is generally well-tolerated. In earlier studies, patients experienced less pain and required fewer opioids after surgery, indicating effective pain management by the implant. Safety checks included regular monitoring of vital signs and heart activity, revealing no major issues.

Bupivacaine, the main ingredient in INL-001, is already used in other medical products, providing reassurance about its safety. However, individual reactions can vary, so it is important to consider personal health conditions and consult a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for post-surgical pain, which often relies on systemic medications like oral opioids or non-steroidal anti-inflammatory drugs (NSAIDs), the INL-001 implant delivers bupivacaine hydrochloride directly at the surgical site. This targeted delivery can provide prolonged pain relief right where it's needed, potentially reducing the need for systemic medications and their associated side effects. Researchers are excited about this localized approach because it not only promises more effective pain management but also lessens the risk of opioid dependency, a major concern with traditional pain treatments.

What evidence suggests that the INL-001 implant is effective for pain management following soft-tissue surgeries?

Studies have shown that the INL-001 (bupivacaine hydrochloride) implant, which participants in this trial will receive, effectively controls pain after surgery. Patients who received this implant reported significantly less pain and used fewer opioids in the first 24 hours post-surgery compared to those who did not receive it. This indicates that the implant helps manage pain and reduces the need for additional pain medications. Research also shows that most people can use this treatment without serious side effects. Overall, INL-001 appears promising for easing pain after soft-tissue surgeries. ^{1 3 5 6 7}

Who Is on the Research Team?

Anne Arriaga

Principal Investigator

Lotus Clinical Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• INL-001 (bupivacaine hydrochloride) implant

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7854444/

Pharmacokinetics and Safety of INL-001 (Bupivacaine HCl ... This study demonstrates that the bupivacaine HCl implant, INL-001, is an effective and well-tolerated treatment for postsurgical pain control in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37076252/

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

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03234374?term=MARCAINE&viewType=Table&rank=9

Pharmacokinetics, Relative Bioavailability and Safety of ... The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open ...

4. link.springer.com link.springer.com/article/10.1007/s12325-018-0836-4

Safety and Efficacy of Bupivacaine HCl Collagen-Matrix ... Patients who received INL-001 in both studies reported significantly lower pain intensity and opioid use through 24 h post-surgery versus those ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04785625

NCT04785625 | Efficacy and Safety Study of Postsurgical ... This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/209511s000lbl.pdf

XARACOLL (bupivacaine - accessdata.fda.gov The safety of XARACOLL was evaluated in 11 clinical studies, including two Phase 3 double- blind, placebo implant-controlled studies in patients ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33237534/

Pharmacokinetics and Safety of INL-001 (Bupivacaine HCl ... INL-001 is a bupivacaine HCl collagen-matrix implant that provides extended delivery of bupivacaine directly at the site and avoids the risk of accidental ...