FDA Clears Generic Version of Pain Patch
First Generic Fentanyl Pain Patch Approved for Treating Severe Chronic Pain
Feb. 2, 2005 -- The FDA has approved the first generic version of the Duragesic Patch to treat people with severe chronic pain that cannot be managed with alternative pain killers. The generic version will be sold under the name Fentanyl Transdermal System.
The approval will likely result in substantial savings for users of the pain management patch because generic versions of prescription drugs typically cost a fraction of their brand-name counterparts.
The agency granted Mylan technologies, Inc. approval to produce a generic version of Alza Corporation's Duragesic Patch. The pain patch is used to treat people with severe chronic pain that cannot be treated with alternative pain killers.
When applied to the skin, the patch releases fentanyl, an opioid pain medication that is slowly absorbed into the body through the skin. Opioids are medications that fall within a class of drugs, which include morphine, codeine, and related drugs. These medications act to block the transmission of pain messages to the brain.
The patch provides pain relief for up to three days.
The original Duragesic Patch was approved in August 1990. It is currently approved to treat chronic pain in people who require continuous treatment with opioids and cannot be managed by acetaminophen-opioid combinations, nonsteroidal pain relievers, or short-acting opioids.
Fentanyl is currently a schedule II controlled substance, which is the highest level of control for drugs used in medicine. Schedule II drugs come under the jurisdiction of the Drug Enforcement Agency (DEA) and are subject to manufacturing quotas set by the agency. The DEA considers medical need for a drug when establishing quotas. Schedule II drugs are also subject to distribution tracking, import and export controls, registration of prescribers and dispensers, and requirements for written prescriptions without refills.