Articles from Purdue Pharma L.P.

Purdue Pharma L.P. (“Purdue”) today announced that the United States Bankruptcy Court for the Southern District of New York (the “Bankruptcy Court”) approved the Company’s disclosure statement for its Chapter 11 Plan of Reorganization. The disclosure statement provides creditors with detailed information on the terms of the Plan and will accompany the ballots that will be sent to the more than 600,000 claimants eligible to vote.

Purdue Pharma L.P. (“Purdue”) today filed a Chapter 11 Plan of Reorganization (the “Plan”) and related disclosure statement with the United States Bankruptcy Court for the Southern District of New York. Assuming full creditor participation, the Plan will deliver to creditors more than $7.4 billion of cash, subject to certain reserves, to compensate victims and abate the opioid crisis. There will also be substantial value created by the continued development and distribution of lifesaving opioid use disorder and overdose rescue medicines for no profit, as well as expected insurance and other recoveries.

Purdue Pharma L.P. (“Purdue”) today announced The Journal of Clinical Pharmacology has published findings from a study in healthy adult volunteers that demonstrated in a clinical model of opioid induced respiratory depression (OIRD), intramuscular (IM) nalmefene (1 mg) reversed fentanyl-induced respiratory depression similar to or better than IM naloxone and intranasal (IN) naloxone.1 Imbrium Therapeutics L.P. (“Imbrium”), a subsidiary of Purdue, sponsored this study.

Purdue Pharma has completed the first phase of a study examining the use of nalmefene hydrochloride (HCI) injection in real-world emergency department (ED) settings. Researchers are now conducting data analysis, with study results expected later this year. The research was funded by Purdue.

Purdue Pharma L.P. (“Purdue”) announced today that the U.S. Food and Drug Administration (FDA) approved the Company’s new drug application for the Zurnai™ (nalmefene injection) Auto-Injector. Zurnai (zur nye) is a single-dose auto-injector that delivers 1.5 mg of nalmefene hydrochloride per actuation.

Purdue Pharma L.P. (“Purdue”) announced today that the company has partnered with MMCAP Infuse to provide buprenorphine and naloxone tablets CIII (generic Suboxone®), a medication for opioid use disorder (“MOUD”), at low cost to correctional facilities for incarcerated individuals with opioid use disorder. MMCAP Infuse is a national cooperative group purchasing organization operated by the State of Minnesota, Office of State Procurement, for government facilities that provide healthcare services. Under the agreement, to increase access to treatment for incarcerated individuals, Purdue will provide for distribution approximately 1.25 million tablets at the cost of one penny ($0.01) per tablet.

Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*. If the auto-injector is approved, it would be the second nalmefene-containing medicine developed by Purdue to specifically address the growing number of opioid overdose deaths, including those due to fentanyl and other synthetic opioids. It would be the first nalmefene medicine available as an auto-injector.

Purdue Pharma L.P. (“Purdue”) announced today that the Company has awarded an investigator-initiated research (IIR) grant to a team of researchers at The University of New Mexico (UNM) for the evaluation of nalmefene hydrochloride (HCl) injection 2mg/2mL (1mg/1mL) in the emergency department setting.

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.

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.

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.

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). Recognizing the value in obtaining data derived from sources other than traditional clinical trials, the Company will provide support for select investigations that explore outcomes associated with Nalmefene HCl injection in a real-world setting reflecting the current opioid overdose environment.

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.* Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose.1

Purdue Pharma L.P. (“Purdue”) announced that FDA has accepted and granted priority review to the company’s Abbreviated New Drug Application (ANDA) for Nalmefene Hydrochloride (HCI) injection, 2 mg/2 mL (1mg/1mL) Prefilled Syringe.* 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. 1

Purdue Pharma L.P. lauds the Prescription Drug Safety Network (“the Network”) for educating thousands of students about prescription drug safety during the 2021-2022 school year. The Network, of which Purdue Pharma L.P. is a founding member, released annual impact data for the digital education curriculum it provides to middle and high school students across the U.S. The curriculum was made available to schools at no cost through the Network’s strategic partnership with EVERFI, the leading Impact-as-a-ServiceTM education innovator.

Purdue Pharma L.P. announced today that Nalmefene Hydrochloride injection, 2mg/2mL (1mg/1mL) is now available in the U.S. for use by healthcare professionals. 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.1

Harm Reduction Therapeutics (HRT) will receive up to $11 million of additional financial support from Purdue Pharma L.P. to advance its development of a low-cost, over-the-counter (OTC) naloxone nasal spray in the United States. Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose.

Purdue Pharma L.P. is accepting proposals for investigator-initiated research (IIR) to assess opioid overdose reversal in Emergency Department (ED) and Emergency Medical Service (EMS) settings. Because we recognize there is value in data derived from sources other than traditional clinical trials, the Company will provide support for select investigations that explore the real-world clinical safety and effectiveness of nalmefene hydrochloride injection, 2mg/2mL (1mg/1mL),1 alone, or in sequence with naloxone, for the treatment of known or suspected opioid overdose in ED/EMS settings.

Purdue Pharma L.P. announced today that FDA has approved its abbreviated new drug application for Nalmefene hydrochloride injection, 2mg/2mL (1mg/1mL).1 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. The Company will be distributing injectable nalmefene for no profit.

Purdue Pharma L.P. today announced its intent to appeal today’s ruling by the United States District Court for the Southern District of New York, which vacated the Bankruptcy Court’s September 2021 order confirming its chapter 11 plan of reorganization (the “Plan”). The company will simultaneously continue its efforts to forge yet further consensus around a Plan that will deliver billions of dollars to the American people for opioid abatement. The current Plan enjoys overwhelming support, including from every one of the many ad hoc creditor groups in the case and more than 95% of Purdue’s over 120,000 voting creditors, including 43 states and territories. Fewer than 20 stakeholders appealed.

Following the United States Bankruptcy Court approval of the Purdue Pharma L.P. chapter 11 plan of reorganization (the “Plan”), the name of the new company that will emerge was announced: Knoa Pharma LLC (pronounced “No-ah”). The name was selected by the Company’s creditors.

The United States Bankruptcy Court for the Southern District of New York (the “Bankruptcy Court”) today approved the Purdue Pharma L.P. chapter 11 plan of reorganization (the “Plan”). The Plan received overwhelming support from more than 95% of voting creditors, including every voting class of creditors and bi-partisan state attorneys general from 43 states and territories.

Purdue Pharma L.P. today announced preliminary voting results that show overwhelming support for its chapter 11 plan of reorganization (“The Plan”). More than 95% of the 120,000-plus votes submitted were in favor of confirmation. Out of almost 5,000 state and local governmental creditors, almost 97% voted to accept the plan. The votes were calculated by PrimeClerk, Purdue’s court-authorized solicitation and balloting agent, and the filing is available on the docket via this link.

Purdue Pharma L.P. (“Purdue”) announced that FDA has accepted and granted priority review to the company’s Abbreviated New Drug Application for the vial dosage form of nalmefene hydrochloride injection.

Purdue Pharma L.P. today announced that the United States Bankruptcy Court for the Southern District of New York (the “Bankruptcy Court”) has approved, among other things, the adequacy of Purdue’s disclosure statement (the “Disclosure Statement”) filed in connection with its chapter 11 plan of reorganization (the “Plan”). With this approval, Purdue may now begin providing ballots and information to over 600,000 claimants. A hearing to consider confirmation of the broadly supported Plan by the Bankruptcy Court is currently scheduled to commence on August 9, 2021.