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Details:
ATX-101 is a small product placed directly into the TKA surgical site in a simple, ‘place & go’ manner designed to add minimal extra complexity and time to the procedure.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: ATX-101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Allay Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Details:
ATX101 is a novel investigational configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following total knee arthroplasty.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: ATX101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2024
Details:
Probudur is a single injection liposomal bupivacaine formulation. It is being evaluated in preclinical trials for the treatment of postoperative pain.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Probudur
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 07, 2024
Details:
Through the agreement, Premier will have access of EXPAREL (bupivacaine), a single-dose local and regional analgesic that provides prolonged postsurgical pain control while reducing reliance on opioids.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Exparel
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Premier
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 07, 2024
Details:
The partnership aims to expand the sales network supporting Zynrelef (bupivacaine and meloxicam) extended-release solution, the first and only dual-acting local anesthetic, for post-operative pain.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Heron Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 07, 2024
Details:
Under the agreement, Maruishi will have the exclusive rights to develop and commercialize Allay’s lead investigational drug candidate, ATX101, a non-opioid, bupivacaine-based drug product, and other ultra-sustained analgesic implantable drug candidates for acute pain in Japan.
Lead Product(s): Bupivacaine
Therapeutic Area: Orthopedics/Orthopedic Surgery Product Name: ATX-101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Maruishi Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 18, 2023
Details:
EXPAREL® (bupivacaine liposome injectable suspension) expand label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Exparel
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2023
Details:
Probudur (bupivacaine) is Virpax’s post-operative, ultra-long-acting anesthetic injection product candidate for post-operative pain management that is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Probudur
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2023
Details:
Probudur (bupivacaine) is Virpax’s post-operative, ultra-long-acting anesthetic injection product candidate for post-operative pain management that is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Probudur
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2023
Details:
ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2022
Details:
Second Phase 3 study of EXPAREL (bupivacaine) achieves primary and key secondary endpoints; safely demonstrating statistically significant reductions in postsurgical pain and opioid consumption through 96 hours.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Exparel
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2022
Details:
EXPAREL achieved the study’s primary endpoint demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (p<0.01).
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Exparel
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Details:
POSIMIR® (bupivacaine solution) for infiltration use reduced mean pain over 72 hours after arthroscopic subacromial decompression surgery compared with vehicle control and improved several measures of postoperative opioid use.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Posimir
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2022
Details:
ZYNRELEF (bupivacaine) is first and only therapy for pain management to be rigorously tested demonstrated superiority to bupivacaine solution, and sustained postoperative pain relief for up to 72 hours and decreased need for opioids, with more patients opioid-free.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2022
Details:
New interim data from Phase 2 study suggests ZYNRELEF (bupivacaine) was well-tolerated and may effectively manage postpartum pain and minimize postoperative opioid use in women undergoing Caesarean sections.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
ZYNRELEF is first and only therapy of dual-acting fixed-dose combination of local anesthetic bupivacaine and a low dose of meloxicam, for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2022
Details:
GTX-101, a novel bio-adhesive film forming topical spray formulation of bupivacaine for the treatment of Postherpetic Neuralgia (PHN). GTX-101 could provide significant benefits faster onset of action and longer duration of pain relief over current standard of care.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: GTX-101
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2021
Details:
Allay intends to proceed into a Phase 2b study of ATX-101 in total knee arthroplasties (TKA, also called total knee replacements) in the United States.
Lead Product(s): Bupivacaine
Therapeutic Area: Orthopedics/Orthopedic Surgery Product Name: ATX-101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Arboretum Ventures
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Series C Financing September 15, 2021
Details:
ZYNRELEF is an extended-release solution of bupivacaine and meloxicam that is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
Under the terms of the agreement, Eurofarma obtains the exclusive right to market and distribute EXPAREL in 19 countries in Latin America, including Argentina, Brazil, Colombia, and Mexico.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Exparel
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eurofarma Laboratorios S.A
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 22, 2021
Details:
Proceeds from the sale of the Notes will be used for the commercial launch of ZYNRELEFTM (bupivacaine and meloxicam) extended-release solution, as well as for general working capital.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: J. Wood Capital Advisors LLC
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Financing May 25, 2021
Details:
ZYNRELEF, the first and only extended-release dual-acting local anesthetic (DALA), delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2021
Details:
ATX-101 is a novel configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following total knee arthroplasty.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: ATX-101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2021
Details:
POSIMIR is the only approved sustained-release bupivacaine product indicated for up to 72 hours of post-surgical analgesia from a single application.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Posimir
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2021
Details:
OncoZenge is developing the BUPI project under the BupiZenge ® brand , for the treatment of pain due to oral mucositis, a serious side effect of cancer treatment. BupiZenge ® has shown promising results in a phase 2 study. The capital will be used to finance the phase 3 study.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: BupiZenge
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Baltic Sea Foundation
Deal Size: $8.3 million Upfront Cash: Undisclosed
Deal Type: Financing November 16, 2020
Details:
The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the Complete Response Letter (CRL) issued by the FDA in June 2020.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Zynrelef is a non-opioid, dual-acting analgesic, utilizing a fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2020
Details:
The CHMP positive opinion was based on the results of four pivotal Phase 3 studies that demonstrated improvements in pain reduction and opioid use.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Exparel
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2020
Details:
More than 90% of patients receiving HTX-011, along with postoperative over-the-counter acetaminophen and ibuprofen, remained opioid-free throughout the 72-hour period following hernia repair surgery.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
HTX-011 is the first and only extended–release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
Results show an opioid-reducing benefit of adding EXPAREL to bupivacaine transversus abdominis plane (TAP) blocks for cesarean delivery.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Exparel
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Details:
The CHMP's positive opinion is based on the results of Heron's two Phase 3 studies of ZYNRELEF.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2020
Details:
The agreement between the two companies to jointly market and promote the use of EXPAREL® for orthopedic procedures in the United States will terminate on January 2, 2021.
Lead Product(s): Bupivacaine
Therapeutic Area: Neurology Product Name: Exparel
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: DePuy Synthes Sales Inc.
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination July 02, 2020
Details:
HTX-011 reduced pain and opioid use after primary total knee arthroplasty, The study met all primary and key secondary endpoints, with HTX-011 demonstrating statistically significant reductions in pain intensity following surgery.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Orthopedics/Orthopedic Surgery Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2020
Details:
The study initiation follows clearance from the US Food and Drug Administration (FDA) of Heron's Investigational New Drug (IND) application for HTX-034 for the treatment of postoperative pain.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
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