The US Food and Drug Administration (FDA) announced the approval of 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 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 FDA release says.

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 programme (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 paediatric 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.