Purdue Pharma

Purdue Pharma L.P. Awards Grant for Investigator-initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection

Retrieved on: 
Wednesday, March 27, 2024

“We are enthusiastic about supporting research that can contribute to addressing the opioid overdose crisis.”

Key Points: 
  • “We are enthusiastic about supporting research that can contribute to addressing the opioid overdose crisis.”
    The prospective, randomized study, “Evaluation of Nalmefene HCl Injection for Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in an Emergency Department,” will compare the efficacy and safety of nalmefene HCl injection to naloxone injection in the treatment of recurrent respiratory depression due to opioid overdose.
  • Nalmefene HCl injection 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.
  • Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.1 The Company distributes nalmefene HCl injection for no profit.
  • The study will be independently developed and carried out by UNM’s research team with Purdue Pharma providing only funding and nalmefene HCI injection.

Scouting Settlement Trust to Advance Partial Payments to Survivors while Litigation is Pending

Retrieved on: 
Monday, February 12, 2024

Under the Advance Payment Program ("APP"), eligible claimants will be able to receive payments of $1,000 before their allowed claim amount is finally determined.

Key Points: 
  • Under the Advance Payment Program ("APP"), eligible claimants will be able to receive payments of $1,000 before their allowed claim amount is finally determined.
  • Eligibility to participate in the APP will be determined based upon a rigorous application of criteria to the information provided to the Scouting Settlement Trust (the "Trust") by individual claimants.
  • The Trust will – over time – make multiple payments on Survivors' claims as more funds are paid into the Trust and illiquid Trust assets are reduced to cash.
  • Litigation: The Trust also has litigation pending against dozens of insurance companies over billions of dollars more in coverage.

Harm Reduction Therapeutics Introduces RiVive™, Over-the-Counter Opioid Overdose Reversal Medication

Retrieved on: 
Wednesday, December 20, 2023

Harm Reduction Therapeutics (HRT), an independent, 501(c)(3) non-profit pharmaceutical company, announced that it has begun shipping RiVive™ (naloxone HCl nasal spray 3 mg), an FDA-approved, over-the-counter (OTC) medication for the emergency treatment of opioid overdose.

Key Points: 
  • Harm Reduction Therapeutics (HRT), an independent, 501(c)(3) non-profit pharmaceutical company, announced that it has begun shipping RiVive™ (naloxone HCl nasal spray 3 mg), an FDA-approved, over-the-counter (OTC) medication for the emergency treatment of opioid overdose.
  • “HRT is the only non-profit pharmaceutical company focused on saving lives that would otherwise be lost to opioid overdose,” said Craig Landau, MD, President and CEO of Purdue.
  • As a result of our collective efforts, this medication will save lives.”
    HRT’s mission is to prevent opioid overdose deaths by making low-cost intranasal naloxone available to everyone without a prescription.
  • HRT will initially distribute to harm reduction community organizations and local and state governments.

The roots of the North American opioid crisis, and 3 key strategies for stopping it

Retrieved on: 
Tuesday, October 17, 2023

The Netflix series Painkiller recently depicted how the over-prescribing of the medicine OxyContin wreaked havoc on American society.

Key Points: 
  • The Netflix series Painkiller recently depicted how the over-prescribing of the medicine OxyContin wreaked havoc on American society.
  • Today the grim reality is that opioid-related deaths in North America reached a record level in 2022, with more than 109,000 fatalities in the United States.
  • The opioid overdose crisis has been ongoing for over two decades in Canada and the U.S.

The roots of the crisis

    • After introduction of the opioid painkiller OxyContin in 1996, Purdue Pharma marketed the drug aggressively, underplaying its potential for addiction.
    • To address addiction, prescription monitoring programs aimed to limit supply but many patients then sought illicit opioids, leading to large heroin markets in the 2010s.
    • Fentanyl is extremely toxic — up to 100 times stronger than heroin — and is largely responsible for the increase in overdose deaths.

1. Treat substance use disorders as a public health problem

    • In reality the data shows that illegal drug prices have fallen whilst purity and deaths have increased.
    • Overdose deaths have also increased in prisons showing that places with even the highest level of security are vulnerable to drug smuggling.
    • Focusing on the opioid crisis through a public-health approach includes massively increasing access to care and treatment for patients experiencing substance use disorder.

2. Find better treatments through research

    • Although these are effective when used, there are barriers to access and long-term engagement with these treatments.
    • We need more innovation to rapidly increase access to care and to find better therapies that suit the needs of different patients.
    • These research initiatives aim to increase the number of evidence-based treatments that can be used to enhance patient recovery and quality of life.

3. Stop the international spread of the epidemic

    • Currently the epidemic is contained within North America but there is the real concern of the crisis spreading to other countries.
    • Clinicians must remain actively vigilant on how they prescribe these drugs.
    • There should be greater international regulation in the marketing and operational strategies of pharmaceuticals, and oversight of the “revolving door” between industry and regulator employment.
    • There is a potential conflict of interest when pharma companies hire the government employees who oversee their applications.

Ligandal Inc. Appoints Tushar Nuwal as Chief Operating Officer and Chief Business Officer

Retrieved on: 
Monday, August 7, 2023

NEW YORK, Aug. 7, 2023 /PRNewswire/ -- Ligandal Inc., an early-stage genetic medicine biotechnology company, announces the appointment of Tushar Nuwal as Chief Operating Officer and Chief Business Officer.

Key Points: 
  • NEW YORK, Aug. 7, 2023 /PRNewswire/ -- Ligandal Inc., an early-stage genetic medicine biotechnology company, announces the appointment of Tushar Nuwal as Chief Operating Officer and Chief Business Officer.
  • Mr. Nuwal brings 20 years of biopharmaceutical experience, including roles at small and large pharmaceutical companies.
  • "We are elated to welcome Tushar to Ligandal.
  • His leadership spans across R&D, manufacturing, product & launch management, operations, business & corporate development, licensing, portfolio, and commercial strategy.

Ligandal Inc. Appoints Tushar Nuwal as Chief Operating Officer and Chief Business Officer

Retrieved on: 
Monday, August 7, 2023

NEW YORK, Aug. 7, 2023 /PRNewswire/ -- Ligandal Inc., an early-stage genetic medicine biotechnology company, announces the appointment of Tushar Nuwal as Chief Operating Officer and Chief Business Officer.

Key Points: 
  • NEW YORK, Aug. 7, 2023 /PRNewswire/ -- Ligandal Inc., an early-stage genetic medicine biotechnology company, announces the appointment of Tushar Nuwal as Chief Operating Officer and Chief Business Officer.
  • Mr. Nuwal brings 20 years of biopharmaceutical experience, including roles at small and large pharmaceutical companies.
  • "We are elated to welcome Tushar to Ligandal.
  • His leadership spans across R&D, manufacturing, product & launch management, operations, business & corporate development, licensing, portfolio, and commercial strategy.

FDA Approves Harm Reduction Therapeutics’ Over-the-Counter Opioid Overdose Reversal Medication

Retrieved on: 
Tuesday, August 1, 2023

FDA has approved Harm Reduction Therapeutics’ (HRT) new drug application for RiVive™ (Naloxone HCl Nasal Spray 3 mg) to be available over the counter (OTC) for the emergency treatment of opioid overdose.

Key Points: 
  • FDA has approved Harm Reduction Therapeutics’ (HRT) new drug application for RiVive™ (Naloxone HCl Nasal Spray 3 mg) to be available over the counter (OTC) for the emergency treatment of opioid overdose.
  • Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose.
  • As an independent, 501(c)(3) non-profit pharmaceutical company, HRT’s mission is to prevent opioid overdose deaths by making low-cost intranasal naloxone available to everyone without a prescription.
  • Since 2018, Purdue has supported HRT’s mission by contributing millions of dollars, extensive technical expertise, and rights to important data to support the development of this opioid overdose reversal medication.

Second Circuit Court Upholds Purdue Pharma’s Plan of Reorganization on Appeal

Retrieved on: 
Tuesday, May 30, 2023

Today, the U.S. Court of Appeals for the Second Circuit ruled in favor of Purdue Pharma’s chapter 11 Plan of Reorganization (the “Plan”), affirming the bankruptcy court’s September 2021 confirmation order.

Key Points: 
  • Today, the U.S. Court of Appeals for the Second Circuit ruled in favor of Purdue Pharma’s chapter 11 Plan of Reorganization (the “Plan”), affirming the bankruptcy court’s September 2021 confirmation order.
  • “The Second Circuit’s ruling is a victory for Purdue’s creditors, including all 50 states, local governments, and victims who overwhelmingly support the Plan of Reorganization.
  • Once consummated, the Plan will deliver billions of dollars of value to fund programs specifically for abatement of the opioid crisis.
  • Upon emergence, Purdue Pharma will cease to exist and a new company, Knoa Pharma, will emerge with a uniquely public-minded mission.

Purdue Pharma L.P. to Provide Funding Opportunities for Investigator-Initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection

Retrieved on: 
Tuesday, March 28, 2023

Purdue Pharma L.P. is accepting proposals for investigator-initiated research (IIR) to examine the outcomes associated with the use of Nalmefene Hydrochloride injection, 2mg/2mL (1mg/1mL).

Key Points: 
  • Purdue Pharma L.P. is accepting proposals for investigator-initiated research (IIR) to examine the outcomes associated with the use of Nalmefene Hydrochloride injection, 2mg/2mL (1mg/1mL).
  • Nalmefene HCl injection 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.1 The Company distributes Nalmefene HCl injection for no profit.
  • “We look forward to supporting continued exploration of real-world use of Nalmefene HCl injection through these research efforts,” said Monica Kwarcinski, PharmD, Vice President, Medical Affairs at Purdue Pharma.
  • Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.

Harm Reduction Therapeutics to Receive Additional Funding for its Low-Cost Over-the-Counter Opioid Overdose Reversal Medication from Purdue Pharma

Retrieved on: 
Tuesday, March 21, 2023

The Bankruptcy Court today approved Purdue Pharma providing Harm Reduction Therapeutics (HRT) up to $9 million in additional financial support to fund commercial readiness for HRT’s low-cost over-the-counter (OTC) intranasal naloxone spray, tradename RiVive.

Key Points: 
  • The Bankruptcy Court today approved Purdue Pharma providing Harm Reduction Therapeutics (HRT) up to $9 million in additional financial support to fund commercial readiness for HRT’s low-cost over-the-counter (OTC) intranasal naloxone spray, tradename RiVive.
  • In support of HRT’s mission, since 2018 Purdue has provided financial contributions, technical expertise, and rights to data.
  • The additional funding approved today will help HRT continue its work toward making OTC naloxone nasal spray available to the public.
  • There is no guarantee that OTC naloxone intranasal spray will successfully complete development or gain FDA approval.