An FDA panel recommends the agency reject Hydexor, a novel acute pain drug consisting of hydrocodone, acetaminophen and promethazine, Medscape reports.
Here's what you should know:
1. Committee members had concerns on a number of issues including:
- A lack of data on how the drug affects the elderly
- Inadequate plans to prevent abuse and misuse
- The inflexibility of a single-dose product
2. Boston-based Brigham Women's Hospital Pain Trials Center Director Edward Michna, MD, said, "This drug, while a good idea, wasn't really well thought-out in terms of how we use these drugs clinically."
3. If the drug is approved by the FDA, it would be the first to include antiemetic properties.
4. The drug is intended to provide short-term management of acute pain, while preventing opioid-induced nausea and vomiting.
For more information on the drug, click here.