XaraColl (bupivacaine) / Innocoll - LARVOL DELTA

Enhancing Pain Management for Open Inguinal Hernia Repair With a Novel Long-Acting Bupivacaine Drug Device (Xaracoll®) in Multimodal Pain Control: A Quality Improvement Initiative to Reduce Post-Operative Opioid Prescribing. (PubMed, Cureus) - "Intra-operative analgesics administered and quantified by oral morphine equivalents (OME), opioid administration for pain control postoperatively, opioid prescriptions upon discharge, postoperative pain scores, and turnaround time (TAT) were compared. Conclusion This study demonstrates compelling evidence that Xaracoll® is a useful analgesia adjuvant for inguinal hernia repair, significantly reducing the need for opioids in the PACU and decreasing doses of opioid medications upon discharge. Xaracoll® is effective in minimizing postoperative pain and opioid medication dosages upon discharge as part of a multimodal approach to pain and improving patient experience. Further research is warranted to evaluate Xaracoll®'s role in pain control in the PACU and on discharge."

Journal • Anesthesia • Gastroenterology • Pain

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. (PubMed, Reg Anesth Pain Med) - P3 | "The study design was limited by not containing an active comparator. Compared with placebo, INL-001 provides postoperative analgesia that is temporally aligned with the period of maximal postsurgical pain in abdominoplasty and offers a favorable safety profile."

Clinical • Journal • Aesthetic Medicine • Back Pain • Musculoskeletal Pain • Pain

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries (clinicaltrials.gov) - P3 | N=100 | Completed | Sponsor: Innocoll | Recruiting ➔ Completed

Trial completion • Aesthetic Medicine • Gastroenterology • Gynecology • Pain

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Innocoll | Trial completion date: Jul 2022 ➔ Jan 2023 | Trial primary completion date: Jul 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Aesthetic Medicine • Gastroenterology • Gynecology • Pain

SABER-Bupivacaine Reduces Postoperative Pain and Opioid Consumption After Arthroscopic Subacromial Decompression: A Randomized, Placebo-Controlled Trial. (PubMed, J Am Acad Orthop Surg Glob Res Rev) - "Compared with placebo, SABER-Bupivacaine reduced pain and opioid analgesic consumption over 72 hours after arthroscopic subacromial decompression and prolonged the time to first use of opioid rescue analgesia. No safety signals were noted during the immediate postoperative period or at 6-month follow-up."

Journal • Orthopedics • Pain

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Innocoll | Trial completion date: Feb 2022 ➔ Jul 2022 | Trial primary completion date: Feb 2022 ➔ Jul 2022

Trial completion date • Trial primary completion date • Aesthetic Medicine • Gastroenterology • Gynecology • Pain

Innocoll Announces Successful Completion of Debt Refinancing (Businesswire) - "Innocoll Biotherapeutics plc...announced today the successful refinancing of its existing term loan facility with a new $125 million term loan provided by funds managed by Oaktree Capital Management, L.P. ('Oaktree'). The new term loan meaningfully strengthens Innocoll’s financial flexibility and enables the Company to further invest in its R&D program and commercial organization for its innovative products....'By continuing to invest in our R&D and building our commercial organization, we are confident that we will position our innovative post-surgical, non-opioid pain products XARACOLL (bupivacaine hydrochloride implant) and POSIMIR® (bupivacaine solution) for long-term success.'"

Financing • Pain

Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty (clinicaltrials.gov) - P3; N=366; Completed; Sponsor: Innocoll; Recruiting ➔ Completed

Trial completion • Aesthetic Medicine • Pain

Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty (clinicaltrials.gov) - P3; N=372; Recruiting; Sponsor: Innocoll; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Aesthetic Medicine • Pain

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries (clinicaltrials.gov) - P3; N=100; Recruiting; Sponsor: Innocoll; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Aesthetic Medicine • Gastroenterology • Gynecology • Pain

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries (clinicaltrials.gov) - P3; N=100; Not yet recruiting; Sponsor: Innocoll

Clinical • New P3 trial • Aesthetic Medicine • Gastroenterology • Gynecology • Pain

Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty (clinicaltrials.gov) - P3; N=372; Not yet recruiting; Sponsor: Innocoll

Clinical • New P3 trial • Aesthetic Medicine • Pain

Pharmacokinetics and Safety of INL-001 (Bupivacaine HCl) Implants Compared with Bupivacaine HCl Infiltration After Open Unilateral Inguinal Hernioplasty. (PubMed, Adv Ther) - P1 | "These findings demonstrate that INL-001 provides immediate and extended delivery of bupivacaine and is well tolerated in patients undergoing open inguinal hernioplasty with no adverse effect on wound healing."

Clinical • Journal • PK/PD data • Anesthesia • Pain

Innocoll Announces Commercial Launch of XARACOLL (bupivacaine HCI) implant, a Non-opioid, Drug-device Treatment Option for Acute Postsurgical Pain Relief for up to 24 Hours Following Open Inguinal Hernia Repair in Adults (PRNewswire) - "Innocoll Holdings Limited...announced today the commercial launch of XARACOLL® (bupivacaine HCI) implant for acute postsurgical pain relief up to 24 hours in adults following open inguinal hernia repair, a painful and commonly performed surgery....XARACOLL will be launched through a partnership between Mallinckrodt Pharmaceutical's Acute Care Sales Team and Innocoll's Hospital Sales Team....Over the next few weeks, XARACOLL will become available to order for next-day delivery. The wholesale acquisition cost of XARACOLL is $234 per surgery."

Launch US • Pricing • Pain

"The @US_FDA approved #Xaracoll a #bupivacaine implant for acute postsurgical #painrelief in adults following #hernia repair. https://t.co/ajSKBXaZFi #herniarepair #fda #surgery" (@painmednews)

Clinical • FDA event • Gastroenterology • Pain

FDA Approves XARACOLL (bupivacaine HCl) Implant, a Non-opioid, Drug-device Treatment Option for Acute Postsurgical Pain Relief for up to 24 Hours Following Open Inguinal Hernia Repair in Adults (PRNewswire) - "Innocoll Holdings Limited...announced today that the US Food and Drug Administration (FDA) has approved Xaracoll® for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair, a painful and commonly-performed surgery."

NDA • Pain

The pharmacokinetics and safety of an intraoperative bupivacaine-collagen implant (XaraColl) for postoperative analgesia in women following total abdominal hysterectomy (J Pain Res) - P=NA, N=12; PMID: 23503706; "The pharmacokinetic profile displayed a double peak in bupivacaine concentration with the second peak occurring up to 24 hours after the first and at a generally higher concentration. The time to maximum concentration (tmax) varied from 0.5 to 24 hours (median 12 hours) according to which peak predominated. The mean maximum concentration (Cmax) was 0.22 μg/mL and the maximum individual Cmax was 0.44 μg/mL..."

PK/PD data • Pain

Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant (clinicaltrials.gov) - P2; N=64; Completed; Sponsor: Innocoll; Phase classification: P3 ➔ P2

Phase classification • Anesthesia • Biosimilar

Innocoll Holdings Limited announces FDA acceptance of New Drug Application for Xaracoll for the management of postsurgical pain after open inguinal hernia surgery (PRNewswire) - "Innocoll Holdings Limited...today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for XARACOLL® (bupivacaine hydrochloride collagen-matrix implants), an investigational agent for the management of postsurgical pain after open inguinal hernia surgery. The FDA set a PDUFA goal date of August 26, 2020."

NDA • PDUFA date

Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair (clinicaltrials.gov) - P3; N=159; Recruiting; Sponsor: Innocoll; Phase classification: P2/3 ➔ P3

Phase classification

Safety and Efficacy of Bupivacaine HCl Collagen-Matrix Implant (INL-001) in Open Inguinal Hernia Repair: Results from Two Randomized Controlled Trials. (PubMed, Adv Ther) - P3; "These findings indicate that INL-001 results in post-inguinal hernia repair analgesia that is temporally aligned with the period of maximal postsurgical pain and may reduce the need for opioids while offering a favorable safety profile."

Clinical • Journal