Purdue Pharma Bankruptcy
The Purdue Pharma bankruptcy does not affect our ability to meet our obligations to patients, customers, or commercial partners. There is no interruption in our manufacturing or supply. We remain open for business.
Purdue seeks to achieve a global bankruptcy settlement that would deliver more than $10 billion in value, including 100% of Purdue’s assets and millions of doses of opioid addiction treatment and overdose reversal medicines, to communities across the country to fund programs specifically for abatement of the opioid crisis. The bankruptcy settlement will also deliver funds to private abatement trusts for the benefit of personal injury claimants.
If Purdue’s settlement is approved, Purdue’s assets will be transferred to a new company. 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. The company will continue serving patients and consumers who rely on its medicines and products, pursuing its pipeline, and introducing medicines that will help save and improve lives.
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 more than $10 billion in value, including providing, at cost, 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 to healthcare professionals.
- The new company will ultimately be owned by a new National Opioid Abatement Trust established for the benefit of the American people. State and local governments will neither own, nor operate the new company.
- 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 $4.275 billion, in addition to the $225 million previously paid to the United States to resolve civil claims, for a total settlement of $4.5 billion.
Public Health Initiatives – The new company will oversee the ongoing development and eventual distribution, at or below cost, of three potentially lifesaving medicines*:
- Buprenorphine naloxone tablets – Purdue can manufacture 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 collaboration with Harm Reduction Therapeutics that will be sold over-the-counter without need of a prescription or request from a pharmacist, and for a fraction of the cost of the existing naloxone nasal spray therapy, making it easier for more people to afford and access.
- 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.
Continuity of Care: The company continues to serve patients who rely on its FDA-approved medicines and other products. We also continue to develop and distribute consumer health and wellness products. We have a diverse portfolio and pipeline of medicines in development that address important medical needs in multiple therapeutic areas such as non-opioid pain relief, oncology, central nervous system disorders, and digestive health.
*This information discusses investigational uses of agents in development and are 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.