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...
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...
I have had severe migraines for over 25 years and have gone to the same doctor for 35. After years of medications not working and taking over 1,600 MG of Advil a day, nothing worked until she gave me hydrocodone 10/325. My migraines the week before my period will be daily for 4-5 days and then I usually have a migraine 1 - 2 days every week. She has given me 30 pills a months for 4 years, with the notes to take 1-2 pills every 4 hours as needed. Well when I have the 4-5 days I will take approx. in those days 20-25 pills depending on when they hit. If it is closer to the weekend I can knock it out in 2 days. During the week I try to manage only taking meds at night. So over the last 25 years I now find that I need to take 2 pills at a time. I have asked that she increase me meds to 45 pills per month. She has refused and now wants me to sign a controlled substance agreement. She says she is concerned amount her medical license. Obviously not my pain or her patient. She ...
You should knowAnswers to your question are meant to provide general health information but should not replace medical advice you receive from a doctor. No answers should be viewed as a diagnosis or recommended treatment for a condition. Content posted by community members does not necessarily reflect the views of Remedy Health Media, which also reserves the right to remove material deemed inappropriate.