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Details:
Naloxone hydrochloride prefilled injection, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan-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 19, 2020
Details:
RiVive (naloxone HCl nasal spray) is an FDA approved, over-the-counter (OTC) medication which is indicated for the emergency treatment of opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: RiVive
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 20, 2023
Details:
RiVive (naloxone HCl) is a μ opioid receptor antagonist. It is an FDA-approved, over-the-counter medication approved for the emergency treatment of opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: RiVive
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 20, 2023
Details:
OX124 (naloxone HCl), is based on Orexo´s world-class drug delivery platform amorphOX® and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OX124
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 28, 2023
Details:
OX124 (naloxone), is based on Orexo´s world-class drug delivery platform amorphOX® and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OX124
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 18, 2023
Details:
Buprenorphine sublingual tablets, is a partial opioid agonist in combination with naloxone, an opioid antagonist, is indicated for the maintenance treatment of opioid dependence.
Lead Product(s): Buprenoprhine,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Suboxone-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 September 06, 2023
Details:
NARCAN (naloxone) Nasal Spray will be the first, life-saving emergency medicine for opioid overdose available on shelves, for Everyone to Help Save a Life from an Opioid Overdose Emergency.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2023
Details:
Naloxone HCl Nasal Spray is the opioid antagonists indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan-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 August 08, 2023
Details:
RiVive™ (Naloxone HCl Nasal Spray 3 mg) an opioid antagonist to be available over the counter (OTC) for the emergency treatment of life-threatening opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Rivive
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2023
Details:
Naloxone hydrochloride nasal spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites, which is investigated for the treatment of Multiple Sclerosis.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan-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 July 19, 2023
Details:
NaxSwab™ OTC Novel Naloxone Nasal Swab is an opioid antagonist that acts by blocking the effects of opioids at the opioid receptors. It is used in emergency rescue environment to potentially revive someone from an opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: NaxSwab
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2023
Details:
OX124 (naloxone), developed using amorphOXTM platform, is a powerful high-dose naloxone rescue medication, designed to reverse opioid overdoses, including those from highly potent synthetic opioids, such as fentanyl.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OX124
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 April 03, 2023
Details:
Narcan® (naloxone HCI) Nasal Spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan
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 29, 2023
Details:
Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive™, for the emergency treatment of known or suspected opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Rivive
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Harm Reduction Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 23, 2023
Details:
The proceeds will be used to fund commercial readiness for HRT’s low-cost over-the-counter (OTC) intranasal naloxone spray, tradename RiVive. Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Rivive
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Purdue Pharma
Deal Size: $29.9 million Upfront Cash: Undisclosed
Deal Type: Financing March 21, 2023
Details:
Naloxone hydrochloride nasal spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Naloxone 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 08, 2023
Details:
Naloxone hydrochloride nasal spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Naloxone 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 March 02, 2023
Details:
Narcan® (naloxone HCI) Nasal Spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan
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 February 15, 2023
Details:
OX124 (naloxone hydrochloride) is a competitive inhibitor of the µ-opioid receptor.7,12 Naloxone antagonizes the action of opioids, reversing their effects. It is being investigated as nasal delivery for opioid overuse.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OX124
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 February 03, 2023
Details:
OX124 (naloxone), developed using amorphOXTM platform, is a powerful high-dose naloxone rescue medication, designed to reverse opioid overdoses, including those from highly potent synthetic opioids, such as fentanyl.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OX124
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 09, 2023
Details:
Narcan® (naloxone HCI) Nasal Spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan
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 06, 2023
Details:
RiVive is an intranasal formulation of naloxone (3.0 mg) delivered as an atomized spray (0.1 ml) using a standard unit dose system for single administration.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: RiVive
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 December 26, 2022
Details:
NARCAN Nasal Spray (naloxone hydrochloride) is a prescription medicine used for the emergency treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan
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 December 06, 2022
Details:
Naloxone is an opioid antagonist that acts by blocking the effects of opioids at the opioid receptors. Pharmacokinetic study data shows NaxSwab OTC has 74% and 1096% higher exposures at 2.5 minutes compared to naloxone HCI 4mg nasal spray and 0.4mg IM naloxone injection.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: NaxSwab
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 December 01, 2022
Details:
Revive (naloxone hydrochloride) is a safe and effective opioid antagonist, originally approved by the FDA in 1971 and has been used for decades by both medical professionals and the lay public to successfully reverse opioid overdoses.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Revive
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 October 11, 2022
Details:
TNX-601 CR (tianeptine oxalate and naloxone controlled-release) for MDD, that was designed to mitigate the risk of parenteral abuse. TNX-601 ER is also designed with abuse deterrent properties but without the µ-opioid receptor antagonist naloxone.
Lead Product(s): Tianeptine Oxalate,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-601
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 03, 2022
Details:
Under its terms, the contract manufacturer will produce Harm Reduction Therapeutics' nasal spray, RiVive™ (3.0mg naloxone), for the emergency treatment of known or suspected opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Revive
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 11, 2022
Details:
TNX-601 ER (tianeptine oxalate) is a novel oral formulation of tianeptine oxalate designed for once-daily daytime dosing that is in the pre-IND (Investigational New Drug) stage of development for the treatment of MDD.
Lead Product(s): Tianeptine Oxalate,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-601
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 July 11, 2022
Details:
Naloxone Nasal Spray, 4mg (generic to Narcan®),is a prescription medicine used for the treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Naloxone-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:
ZIMHI represents a new tool for patients by combining an intuitive, compact, and simple to use intramuscular device with a high dose of naloxone. Successfully treating overdoses involving fentanyl often requires multiple doses of lower-dose or intranasal naloxone products.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Zimhi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: US WorldMeds
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
The additional funding approved today will help HRT continue its work toward making OTC naloxone nasal spray available to the public. HRT plans to file a New Drug Application for naloxone nasal spray with FDA in 2022.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Revive
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Purdue Pharma
Deal Size: $17.5 million Upfront Cash: Undisclosed
Deal Type: Financing March 23, 2022
Details:
HRT001 is an intranasal formulation of naloxone (3.0 mg) delivered as an atomized spray (0.1 ml) using a standard unit dose system for single administration. Its tentatively approved tradename is RiVive™.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: RiVive
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sage Chemical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
Narcan (naloxone hydrochloride) Nasal Spray a US launch generic used to reverse opioid overdose because more than 73,000 deaths record find in US is due to Opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Naloxone 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 December 22, 2021
Details:
Naloxone hydrochloride nasal spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan-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 December 22, 2021
Details:
These results support the dose of naloxone in ZIMHI™ as being appropriate for more likely successful resuscitation from fentanyl overdoses, thereby saving more lives.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Zimhi
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 01, 2021
Details:
Based on this study, the final formulation of TNX-601 CR to be used in Phase 2 testing will be 39.4 mg tianeptine oxalate and 1 mg naloxone for once daily treatment of MDD. Naloxone is included in the formulation to mitigate the potential for high dose parenteral abuse.
Lead Product(s): Tianeptine Oxalate,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-601 CR
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 November 09, 2021
Details:
ZIMHI™ (naloxone HCL Injection, USP) is an opioid antagonist used in adults and children for the treatment of an opioid emergency, such as an overdose or a possible overdose with signs of breathing problems and severe sleepiness or not being able to respond.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Zimhi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2021
Details:
OX124 is a powerful naloxone rescue medication, designed to reverse opioid overdoses, including those from highly potent synthetic opioids, such as fentanyl.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OX124
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 July 16, 2021
Details:
The data analysis showed that in 63% of cases, the clinicians administered more than the standard upper limit of 12 mg of sublingual buprenorphine during emergency department induction, and in 23% of cases, patients were given 28 mg or more.
Lead Product(s): Buprenorphine Hydrochloride,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Zubsolv
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 15, 2021
Details:
ZIMHI is a high-dose naloxone injection product candidate intended for the treatment of opioid overdose. Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: ZIMHI
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 May 17, 2021
Details:
KLOXXADOTM contains twice as much naloxone per spray as Narcan® Nasal Spray 4mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important new treatment option in addressing the opioid epidemic.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Pharmacology/Toxicology Product Name: Kloxxado
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2021
Details:
Adamis had a Type A meeting with the U.S. FDA to review comments on the additional information provided by the company in response to the FDA’s previous CRL regarding the NDA for ZIMHI™, and also to obtain input from the agency concerning the resubmission of the NDA.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: ZIMHI
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 April 12, 2021
Details:
The new patent is the second US patent for OX124. Based on Orexo's innovative scalable intranasal formulation technology, OX124 is a powerful naloxone rescue medication, designed to reverse opioid overdoses, including those from synthetic opioids, such as fentanyl.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: OX124
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 27, 2021
Details:
Naloxone hydrochloride prefilled injection, as an OTC emergency treatment for known or suspected opioid overdose, complete or partial reversal of opioid depression. It is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan-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 January 14, 2021
Details:
The new patent, US Patent further strengthens the company's intellectual property for ZUBSOLV® in the US. Orexo will now have six patents listed in the Orange Book for ZUBSOLV®.
Lead Product(s): Buprenorphine Hydrochloride,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Zubsolv
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 30, 2020
Details:
Under the terms of the agreement, Orexo will be responsible for product supply and Accord will take responsibility for the commercialisation of ZUBSOLV®. Orexo will receive double-digit royalties on future net sales.
Lead Product(s): Buprenorphine Hydrochloride,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Zubsolv
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Accord healthcare
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 07, 2020
Details:
ZIMHI is a high-dose naloxone injection product candidate intended for the treatment of opioid overdose. Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: ZIMHI
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 16, 2020
Details:
The availability of naloxone lotion within the current Phase 3 study offers potential relief to people living with cutaneous T-cell lymphoma whose quality of life is significantly impaired by chronic, unrelenting itching.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Oncology 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 October 06, 2020
Details:
Narcan Nasal Spray was the first intranasal form of naloxone approved by FDA and Health Canada for the emergency treatment of known or suspected opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
The resubmission follows the company’s meeting with the agency in February and is intended to address the issues raised by the FDA in the agency’s November 2019 Complete Response Letter.
Lead Product(s): Naloxone 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 May 18, 2020
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