No set date has been given, but we can assume that this popular opiate will hit markets by next summer.
When is the Proposed Launch Date? Summer 2013
Zogenix, the pharmaceutical company that produced Zohydro, is claiming a potential launch date in the second quarter of 2013--any time between May and August of 2013. So if all goes according to plan, Zohydro will be on the market by the fall of 2013 at the latest.
Where is Zohydro in the FDA Approval Process?
Drugs have to go through hundreds of steps before they are released into the public. On average, it takes 12 years for a drug to be available to the public. Zohydro has come a long way, yet it still has some steps left in the approval process.
Of the 12 steps in the drug approval process, Zohydro is at step 9.
Here’s a recap of what's happened so far:
- In step 7, a New Drug Application (NDA) is submitted to the FDA.
- In step 8, the FDA has 60 days to decide if they will file it to be reviewed.
- If approved, the NDA is then filed and a review team will evaluate the drug's safety and effectiveness (step 9).
So far, Zohydro has passed step 8, a very critical time in this process. The FDA has given the "ok", and Zohydro is now being reviewed. According to a July press release, this process will take 10 months, and the target action date will be March 1, 2013.
If the review is satisfactory, the FDA still has to decide the drug’s professional labeling (step 10) and inspect the facilities where the drug will be manufactured (step 11). Besides all that, the release of Zohydro still hinges on other circumstances, such as market potential, subsequent safety findings, and other uncertainties that may delay the release date.
Will Zohydro be Addictive?
The short answer is, yes. Because Zohydro will contain pure hydrocodone, the FDA plans to release Zohydro as a Schedule II drug, which means that the drug's propensity to be addictive is quite high. Due to the trend already set of abusing even more diluted forms of hycrocodone (such as Vicodin and Oxycontin), we assume that Zohydro will soon become one of the most abused prescription painkillers available.
Until now, hydrocodone was only sold in combination with non-addictive analgesics such as aspirin or acetaminophen (as in Vicodin), and the approval drew criticism from safety advocates who wanted anti-abuse design features that would make it harder for users to crush the pills and snort or inject them.
Vicodin contains up to 10 milligrams of hydrocodone, with a daily maximum dosage of around 60 milligrams. Zohydro ER, which would likely be taken twice a day, could result in a daily dosage of up to 100 milligrams.
To address the concerns of potential addiction, Zogenix is working on the developement of an alternative abuse-resistant formulation of Zohydro. Furthermore, the FDA is requiring post-marketing studies of Zohydro to assess the risk of abuse, addiction and overdose associated with long-term use beyond 12 weeks.