New FDA Approvals
November 1, 2004 3 minutes read
These drugs were recently approved by the FDA:
• Hydromorphone hydrochloride (Palladone) capsules by Purdue Pharma L.P. The FDA has approved hydromorphone hydrochloride (Palladone) 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.
Hydromorphone is an extended-release formulation that comes in 12, 16, 24, and 32 mg capsules. Hydromorphone must be swallowed whole because chewing, dissolving, or crushing the contents of the capsules leads to the rapid absorption of a potentially fatal dose.
This drug only should be used in patients who are already receiving opioid therapy and who require a total daily dose of at least 12 mg oral hydromorphone or its equivalent. Hydromorphone 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.
Hydromorphone currently is a Schedule II controlled substance, 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 hydromorphone, the 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 hydromorphone capsules.
In addition to the potential for abuse and addiction, respiratory depression is the chief potential risk associated with hydromorphone, if not properly dosed. Other common side effects include nausea, vomiting, dry mouth, dizziness, urinary retention, and constipation.
• New indication for duloxetine hydrochloride (Cymbalta) by Eli Lilly & Co. The FDA has approved duloxetine hydrochloride (Cymbalta) capsules for the management of the pain associated with diabetic peripheral neuropathy. This is the first drug specifically approved for this indication. The drug was previously approved for the treatment of major depressive disorder.
The safety and effectiveness of duloxetine were established in two randomized, controlled studies of approximately 1,074 patients. Although the mechanism of action is unknown, patients treated with duloxetine reported a greater decrease in pain compared to placebo. In these trials, 58% of patients treated with duloxetine reported at least a 30% sustained reduction in pain. In comparison, 34% of patients treated with placebo reported this magnitude of sustained pain reduction.
Duloxetine comes in a capsule and can be taken once a day. The recommended daily dose is 60 mg. (Patients in the studies did not tolerate the 120 mg per day — although still considered safe and effective — as well as the 60 mg dose.) The most commonly reported side effects were nausea, dry mouth, constipation, and diarrhea. In some cases, patients experienced dizziness and hot flashes.
Hydromorphone hydrochloride (Palladone); New indication for duloxetine hydrochloride (Cymbalta).You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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