Local Pharmaceutical Company Gets FDA Approval

The Carmel Valley-based Zogenix, Inc. pharmaceutical company recently announced the U.S. Food and Drug Administration approved Zohydro ER extended-release capsules “for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.”

Zogenix expects to launch Zohydro ER in approximately four months, company officials wrote in an announcement released last week. The company has long developed and commercialized products for the treatment of central nervous system disorders and pain, company officials wrote.

The newly approved Zohydro ER is a narcotic painkiller. According to the San Diego Business Journal, gained approval “despite disapproval from an advisory committee which cited addiction concerns.” 

In their announcement, the makers of the drug highlighted the fact that Zohydro ER is the first hydrocodone medication of its kind without acetaminophen, which they noted in high doses over long periods of time has the potential for causing liver injury.

"Zohydro ER fulfills a critical need among people living with chronic pain who meet the criteria for therapy with extended release opioids,” said Dr. Srinivas Nalamachu, M.D., a pain specialist at the International Clinical Research Institute, Overland Park, Kansas and investigator in the clinical trials of Zohydro ER. “It is the first extended-release hydrocodone medicine that is acetaminophen-free. Also, a significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients,"

To read the companies entire statement, visit their web page.