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Details:
The grant will be used for the evaluation of nalmefene hydrochloride (HCl) injection, an opioid antagonist indicated for the complete or partial reversal of opioid drug effects.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Nalmefene HCl-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Purdue Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing March 27, 2024
Details:
The company intends to use the net proceeds for the advancement of its phase 2 trial evaluating, TH104 (nalmefene) for the treatment of moderate-to-severe cholestatic pruritis in primary biliary cholangitis.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: TH104
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: ThinkEquity
Deal Size: $11.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 30, 2023
Details:
Through the agreement, Hillstream aims to acquire a clinical stage asset, AV104 (nalmefene), an opioid antagonist, but first it intends to seek approval in an orphan disease for the treatment of moderate to severe cholestatic pruritis with primary biliary cholangitis.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: AV104
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hillstream BioPharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 11, 2023
Details:
Opvee (nalmefene) nasal spray is an opioid receptor antagonist approved by the Food and Drug Administration (FDA) to for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Opvee
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 30, 2023
Details:
Opvee (nalmefene) nasal spray is an opioid receptor antagonist approved by the Food and Drug Administration (FDA) to for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Opvee
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 23, 2023
Details:
The transaction strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets, notably OPNT003, a patented intranasal nalmefene formulation for opioid overdose treatment.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Indivior
Deal Size: $213.0 million Upfront Cash: $145.0 million
Deal Type: Acquisition March 02, 2023
Details:
OPNT003 is a nasal formulation containing the high affinity opioid antagonist nalmefene. The NDA submission for OPNT003 is supported by results from a pharmacokinetic (PK) study comparing OPNT003 to an intramuscular nalmefene injection.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
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 January 19, 2023
Details:
Nalmefene hydrochloride Injection, a generic opioid system modulator, indicated for the complete or partial reversal of opioid drug effects, including respiratory depression.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Nalmefene Hydrochloride- Generic
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 January 18, 2023
Details:
OPNT003, an intranasal formulation of nalmefene, a more potent, longer acting opioid antagonist that is especially well-suited to treat overdose caused by synthetics, is an investigational treatment for opioid overdose.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
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 November 22, 2022
Details:
OPNT003 is an investigational opioid overdose reversal agent that Opiant has been developing alongside a worsening opioid crisis, driven by the increased prevalence of synthetic opioids, such as illicit fentanyl.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Indivior
Deal Size: $213.0 million Upfront Cash: $145.0 million
Deal Type: Acquisition November 14, 2022
Details:
In the PD study, OPNT003 met the primary endpoint of non-inferiority to nasal naloxone, producing a reversal in remifentanil-induced respiratory depression that was nearly twice that produced by nasal naloxone at five minutes.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biomedical Advanced Research and Development Authority
Deal Size: $10.8 million Upfront Cash: Undisclosed
Deal Type: Funding August 08, 2022
Details:
The implant utilises Titan's proprietary ProNeura™ drug delivery system and combines nalmefene with an ethylene-vinyl acetate (EVA) polymer,l for long-term treatment options in addiction medicine.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 05, 2022
Details:
Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in the management of known or suspected opioid overdose.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Nalmefene Hydrochloride- Generic
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 21, 2022
Details:
The agreement includes an investment by Opiant and a commitment by Aptar to install and maintain equipment in support of increased future production of its Unidose device to meet the potential commercial demand for OPNT003, nasal nalmefene.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Indivior
Deal Size: $2.1 million Upfront Cash: Undisclosed
Deal Type: Collaboration June 08, 2022
Details:
Results from the pharmacokinetic (PK) and pharmacodynamic (PD) studies, in which OPNT003 (nalmefene) demonstrated fast, strong, and long-lasting action and a well-tolerated safety profile, support OPNT003 as a potential new treatment option for opioid overdose.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
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 June 01, 2022
Details:
OPNT003, nasal nalmefene, with 4 mg nasal naloxone hydrochloride met the primary endpoint of non-inferiority, which was designed to assess whether nasal nalmefene performed as well or better than nasal naloxone.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
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 April 27, 2022
Details:
FDA recently approved ANDA for nalmefene hydrochloride Injection, an opioid antagonist indicated for reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in management of known or suspected opioid overdose.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Nalmefene Hydrochloride-Generic
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:
FDA has approved ANDA for Nalmefene hydrochloride injection, an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, induced by either natural or synthetic opioids, and in management of known suspected opioid overdose.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Nalmefene Hydrochloride-Generic
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 23, 2022
Details:
Positive topline results announced from a multi-dose pharmacokinetic study for OPNT003, nasal nalmefene, an investigational treatment for opioid overdose demonstrated rapid nasal absorption in all three study arms.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
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 February 10, 2022
Details:
The contract with BARDA will also potentially allow for the development of OPNT003 as a medical countermeasure in a chemical attack using weaponized synthetic opioids as well as reverse opioid overdoses in the community.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biomedical Advanced Research and Development Authority
Deal Size: $2.2 million Upfront Cash: Undisclosed
Deal Type: Funding January 24, 2022
Details:
Injectable nalmefene, an opioid antagonist designed to reverse opioid overdose, may be another treatment option to help address the growing and continuing crisis of opioid overdose deaths, including those due to fentanyl and other synthetic opioids.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
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 June 10, 2021
Details:
An earlier award of $4.6 million from BARDA, combined with a $7.4 million grant Opiant received from the NIDA, also supports the clinical development and U.S. regulatory submission of OPNT003. The grant increases total potential value of the BARDA contract to $8.1 million.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: BARDA
Deal Size: $8.1 million Upfront Cash: Undisclosed
Deal Type: Funding December 14, 2020
Details:
Agreement combines Opiant’s opioid antagonist OPNT003 nasal nalmefene, with Aptar's FDA-approved Unit Dose System delivery device. OPNT003 is a nasal nalmefene for use in conjunction with Aptar’s Unit Dose System (UDS) for the treatment of opioid overdose.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT003
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Indivior
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 29, 2020
Details:
The study was a cross-over, comparative bioavailability study in healthy volunteers to assess nalmefene absorption from three development formulations of OX125, Orexo's wholly-owned nasal nalmefene product, compared to a nalmefene intramuscular injection.
Lead Product(s): Nalmefene Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OX125
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 June 30, 2020
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