Purdue Pharma Bankruptcy
Purdue’s confirmed Plan of Reorganization (“Plan”) was vacated on appeal by the United States District Court for the Southern District of New York. Purdue is appealing the ruling while simultaneously continuing its efforts to forge yet further consensus around a Plan that will deliver billions of dollars to the American people for opioid abatement.
The District Court decision does not affect Purdue’s operational stability or its ability to produce its many medications safely and effectively. We continue to operate fully, honoring our existing relationships and meeting our obligations to our partners, customers, and consumers. The company continues serving patients and consumers who rely on its medicines and products, pursuing its pipeline, and introducing medicines that will help save and improve lives.
Upon emergence from bankruptcy, substantially all of Purdue’s assets would be transferred to a new company with a public-minded mission. This new company will be governed by new independent board members and will operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis.
Plan of Reorganization Highlights
- The vast majority of proceeds will be used to abate the opioid crisis; these funds cannot be diverted to other purposes.
- The Plan will deliver billions in value, including providing millions of doses of opioid addiction treatment and overdose reversal medicines.
- The new company will be held to the highest standards of conduct, including a prohibition restricting the promotion of opioid products.
- The new company will be owned mostly by the National Opioid Abatement Trust (NOAT), with the Tribe Trust holding a minority interest.
- The Sackler families currently have no role in Purdue and will have no involvement in the new company, and will end their involvement in pharmaceutical companies worldwide. Under the Plan, the Sackler families have agreed to pay $4.325 billion, in addition to the $225 million previously paid to the United States to resolve civil claims.
Public Health Initiatives
Utilizing its scientific and technical expertise, the new company will oversee the ongoing development and eventual distribution of three opioid addiction treatment and overdose reversal medicines that can potentially save and improve lives*.
- Buprenorphine naloxone tablets– Purdue will provide/distribute millions of doses of a generic version of buprenorphine and naloxone sublingual tablets CIII, a treatment for opioid dependence. The FDA approved a generic version of buprenorphine and naloxone tablets developed by Rhodes Pharmaceuticals, a subsidiary of Purdue, in 2020. (For full prescribing information, click here; for the medication guide and warnings, click here.)
- Over-the-counter (OTC) naloxone nasal spray– Purdue has been supporting the development of a low-cost, OTC naloxone intranasal spray through a collaboration with Harm Reduction Therapeutics that will be sold over-the-counter without a prescription, and for a fraction of the cost of existing naloxone nasal spray therapy, making it easier for more people to afford, access, and use.
- Injectable nalmefene– Purdue is developing injectable nalmefene, an opioid antagonist designed to reverse opioid overdose, in three dosage forms: vial, prefilled syringe, and autoinjector. The FDA previously granted Competitive Generic Therapy designation for the vial and prefilled syringe, and Fast Track designation for the autoinjector. Nalmefene 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.
*This information discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that the medications listed will successfully complete development or gain FDA approval.