Last week Zogenix, Inc., a pharmaceutical company that develops products for treating central nervous system disorders and pain, announced positive results from its pivotal Phase 3 efficacy study of Zohydro (hydrocodone bitartrate) extended-release capsules.
Hydrocodone is an opioid pain reliever used to treat moderate to severe pain.
Currently in the U.S., hydrocodone is only available in immediate-release form and is always combined with acetaminophen.
The purpose of including acetaminophen with some opioid medications is to boost their pain-relieving effects.
However, the problem with including acetaminophen in opioid medications is that too much acetaminophen over time can cause liver toxicity and damage.
Zohydro receives FDA approval, it could achieve two firsts:
- The first extended-release hydrocodone treatment, which is better for the treatment of chronic round-the-clock pain.
(It would provide 12-hour pain relief rather than the 4 to 6-hour relief of immediate-release hydrocodone.)
- The first hydrocodone treatment available without acetaminophen.
Dosage strengths used in the Phase 3 study included 10, 20, 30, 40 and 50 mg capsules.
Following completion of an ongoing safety study, Zogenix plans to submit a New Drug Application for Zohydro to the FDA by early 2012, with potential approval and product launch in 2013.
I am excited to know that a hydrocodone product which is extended-release and does not contain acetaminophen is so far along in clinical trials that it may be available in a year and a half or so.
I've long been concerned about the amount of acetaminophen people who have to take hydrocodone regularly are getting, so I'm pleased to know there is an alternative on the horizon.
I'm also happy about the fact that this new medication will be extended release.
The problem with immediate-release medications is not only that you have to take them more often, but they result in multiple hills and valleys of pain relief as the amount of the drug in your system rises and falls.
Extended-release medications gradually release the drug, allowing for a more even and sustained pain relief.
Hopefully Zohydro will become an effective new treatment option for chronic pain patients.
Zogenix Reports Positive Phase 3 Results for Zohydro -- Meets Primary Efficacy Endpoint. 2011 August 17. Zogenix, Inc. News Release.