The Food and Drug Administration (FDA) has approved Palladone (hydromorphone hydrochloride) capsules for the management of persistent moderate to severe pain in patients requiring continuous around-the-clock opioid pain relief for an extended period of time.
Palladone is an extended-release formulation that comes in 12, 16, 24, and 32 milligram (mg.) capsules. This drug should only be used in patients who are already receiving opioid therapy and who require a total daily dose of at least 12 mg. of oral hydromorphone or its equivalent. Palladone offers a therapeutic choice for opioid-tolerant patients who might otherwise be candidates for other opioids and who do not achieve satisfactory therapeutic results with these other products.
The active ingredient in Palladone, hydromorphone, is currently a Scheduled II controlled substance, which is the highest level of control for drugs with a recognized medical use. Based on the risks associated with the drug, including the potential for abuse of Palladone, FDA has worked with the sponsor to develop a comprehensive risk management program (RMP).
The RMP was designed with three potential risk situations identified. These are the risks posed by improper dosing, indication, or patient selection; the risk posed by accidental pediatric exposure to the drug; and the risk posed by abuse or diversion of Palladone Capsules.
As a controlled substance in Schedule II of the Controlled Substances Act (CSA), Palladone also comes under the jurisdiction of the Drug Enforcement Administration (DEA), which administers the CSA. Schedule II drugs are subject to manufacturing quotas set by DEA with input on medical need from FDA, distribution tracking, import and export controls, registration of prescribers and dispensers, and written prescriptions without refills.
In addition to the protection afforded patients through the status of Palladone as a controlled substance, the RMP includes provisions for clear and appropriate labeling, and appropriate education of healthcare professionals, patients, and caregivers. In addition, the sponsor has committed to offer appropriate training to sales representatives. To guard against the inappropriate use of the drug, the RMP also establishes a multifaceted program for monitoring and surveillance of abuse. If abuse, misuse, and diversion occur the program includes an array of interventions.
As part of the RMP, a Medication Guide (FDA-approved patient information which is required to be dispensed with each prescription) has been written for patients prescribed Palladone. FDA requires a Medication Guide only when one or more of the following circumstances exists: (1) the drug is one for which patient labeling could help prevent serious adverse effects; (2) the drug is one that has serious risks of which patients should be made aware because information concerning the risks could affect patients' decision to use, or continue to use the drug; and (3) the drug is important to health and patient adherence to directions for use is crucial to the drug's effectiveness. In addition, the physician labeling for Palladone contains a “black box” warning.