For some reason, Tramadol is an overlooked, misunderstood drug. Even some doctors are confused about some facts that seem to be little known. Most know that tramadol is used to treat pain and comes in both short acting and time released formulas. Various brand name drugs contain tramadol including: Ultracet, Ultram, Ultram ER, Ryzolt, and Rybix. Because these all contain tramadol, they are all worth considering even for the toughest to treat pain. But first, let's clear up some confusion about tramadol.
Is tramadol an opioid? So many people have been lead to believe that tramadol is not an opioid medication. In fact, tramadol is considered an opioid medication because it like morphine and hydrocodone bind to and activate the mu opioid receptor . This mechanism provides the pain relieving, the analgesic effect. And like all the other opioids, the regular use of tramadol can lead to physical dependency . Thus, when this exogenous source of opioids is withdrawn suddenly, a per...
On Monday, the pharmaceutical company Zogenix, Inc. announced the FDA had accepted for review their New Drug Application (NDA) for Zohydro ER™ (hydrocodone bitartrate extended-release capsules).
Hydrocodone is one of the most frequently prescribed opioid drugs for the management of moderate to severe chronic pain. There are, however, two features that set Zohydro ER apart from other hydrocodone products currently available:
It does not contain acetaminophen.
It is an extended-release medication.
Other hydrocodone medications currently available (like Vicodin and Lortab) all contain acetaminophen , which can be hard on the liver. They are also all immediate-release, meaning they have to be taken every four to six hours. Zohydro is intended to be administered every 12 hours to provide round-the-clock pain management for an extended period of time.
Under the Prescription Drug User Fee Act, the goal for a standard review of an NDA is 10 months from NDA subm...
Earlier this month, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee overwhelmingly voted against recommending approval of Zohydro ER, an extended-release version of hydrocodone. If approved, Zohydro ER would have been the first hydrocodone medication available that did not also contain a non-opioid analgesic such as acetaminophen or ibuprofen.
While the FDA does not have to follow the recommendation of its advisory committee, it usually does. The final determination is expected to be made by March 1, 2013.
Despite the fact that Zohydro ER was studied in nearly 1,500 patients––some for as long as a year––and found to be generally safe and well-tolerated with no new or unexpected safety problems, panel members expressed concerns with potential abuse, addiction and long-term safety.
It was noted that the manufacturer didn't offer any solution as to how they would limit unintended use other than the already tight distributio...
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