---
title: "Psych News Alert: FDA Approves Long-Acting Extended-Release Hydrocodone Formulation"
description: The Food and Drug Administration  (FDA) yesterday approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for management of p...
image: https://alert.psychnews.org/hubfs/Imported_Blog_Media/shutterstock_128350532-Jun-24-2025-04-42-02-5258-PM.jpg
---

 10/29/13 12:00 AM

# FDA Approves Long-Acting Extended-Release Hydrocodone Formulation

![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [ Psychiatric News Alert ](https://alert.psychnews.org/author/psychiatric-news-alert)

Share: [facebook-f icon ](http://www.facebook.com/share.php?u=https://alert.psychnews.org/2013/10/fda-approves-long-acting-extended.html) [linkedin-in icon ](http://www.linkedin.com/shareArticle?mini=true&url=https://alert.psychnews.org/2013/10/fda-approves-long-acting-extended.html) [Twitter icon ](https://twitter.com/intent/tweet?url=https://alert.psychnews.org/2013/10/fda-approves-long-acting-extended.html) [pinterest-p icon ](http://pinterest.com/pin/create/link/?url=https://alert.psychnews.org/2013/10/fda-approves-long-acting-extended.html) [envelope icon ](mailto:?body=https://alert.psychnews.org/2013/10/fda-approves-long-acting-extended.html)

| [![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/shutterstock_128350532-Jun-24-2025-04-42-01-5352-PM.jpg?width=200&name=shutterstock_128350532-Jun-24-2025-04-42-01-5352-PM.jpg)](https://alert.psychnews.org/hubfs/Imported_Blog_Media/shutterstock_128350532-Jun-24-2025-04-42-01-5352-PM.jpg) |  |
| --- | --- |

The Food and Drug Administration  (FDA) yesterday approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

Zohydro ER, a Schedule II controlled substance, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain, according to the FDA.

Schedule II drugs can only be dispensed through a physician’s written prescription, and no refills are allowed. There are also stringent recordkeeping, reporting, and physical security requirements for Schedule II controlled substances.

For more information about how the government sets schedules for classifying opioid medications, see the *Psychiatric News* article, [“AMA Delegates Debate Opioid Rescheduling.”](http://psychnews.psychiatryonline.org/newsarticle.aspx?articleid=1712723) To read about the role of psychiatrists in treating patients with chronic pain, see the article ["Psychiatrists' Expertise Useful in Managing Chronic Pain."](http://psychnews.psychiatryonline.org/newsarticle.aspx?articleid=108698)

Also see the book *[Clinical Manual of Pain Management in Psychiatry](http://www.appi.org/SearchCenter/Pages/SearchDetail.aspx?ItemId=62275)* from American Psychiatric Publishing.

(Image: EmiliaUngar/shutterstock.com)

[FDA](https://alert.psychnews.org/tag/fda), [extended release](https://alert.psychnews.org/tag/extended-release), [Schedule 2](https://alert.psychnews.org/tag/schedule-2), [painkillers](https://alert.psychnews.org/tag/painkillers), [rescheduling](https://alert.psychnews.org/tag/rescheduling), [hydrocodone](https://alert.psychnews.org/tag/hydrocodone)

## Related posts

[![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/iStock-665646806.jpg?height=200&name=iStock-665646806.jpg) ](https://alert.psychnews.org/2025/08/intervention-targeting-food-and.html)

[veterans](https://alert.psychnews.org/tag/veterans), [binge eating](https://alert.psychnews.org/tag/binge-eating), [appetite](https://alert.psychnews.org/tag/appetite), [cognitive-behavioral therapy](https://alert.psychnews.org/tag/cognitive-behavioral-therapy), [weight loss](https://alert.psychnews.org/tag/weight-loss), [binge eating disorder](https://alert.psychnews.org/tag/binge-eating-disorder), [regulation of cues](https://alert.psychnews.org/tag/regulation-of-cues)

## [Intervention Targeting Food and Fullness Cues Found Effective for Binge Eating Disorder](https://alert.psychnews.org/2025/08/intervention-targeting-food-and.html)

![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [Psychiatric News Alert](https://alert.psychnews.org/author/psychiatric-news-alert) 

 8/4/25 12:00 AM

[ Read more ](https://alert.psychnews.org/2025/08/intervention-targeting-food-and.html)

[![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/capsules_iStock-505506993-Jun-24-2025-06-31-07-5540-PM.jpg?height=200&name=capsules_iStock-505506993-Jun-24-2025-06-31-07-5540-PM.jpg) ](https://alert.psychnews.org/2017/12/folate-vitamin-d-found-lower-in-people.html)

[psychosis](https://alert.psychnews.org/tag/psychosis), [Schizophrenia Bulletin](https://alert.psychnews.org/tag/schizophrenia-bulletin), [first-episode psychosis](https://alert.psychnews.org/tag/first-episode-psychosis), [folate](https://alert.psychnews.org/tag/folate), [vitamin D](https://alert.psychnews.org/tag/vitamin-d), [Joseph Firth](https://alert.psychnews.org/tag/joseph-firth)

## [Folate, Vitamin D Found Lower in People Who Have Experienced First-Episode Psychosis](https://alert.psychnews.org/2017/12/folate-vitamin-d-found-lower-in-people.html)

![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [Psychiatric News Alert](https://alert.psychnews.org/author/psychiatric-news-alert) 

 12/13/17 12:00 AM

Patients who have experienced first-episode psychosis (FEP) appear to have significantly lower...

[ Read more ](https://alert.psychnews.org/2017/12/folate-vitamin-d-found-lower-in-people.html)

[![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/shutterstock_134901434-Jun-24-2025-09-25-37-9573-PM.jpg?height=200&name=shutterstock_134901434-Jun-24-2025-09-25-37-9573-PM.jpg) ](https://alert.psychnews.org/2015/02/program-for-first-episode-psychosis.html)

[first-episode psychosis](https://alert.psychnews.org/tag/first-episode-psychosis), [Psychiatric Services in Advance](https://alert.psychnews.org/tag/psychiatric-services-in-advance)

## [Program for First-Episode Psychosis Found Successful at CMHC](https://alert.psychnews.org/2015/02/program-for-first-episode-psychosis.html)

![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [Psychiatric News Alert](https://alert.psychnews.org/author/psychiatric-news-alert) 

 2/10/15 12:00 AM

A comprehensive first-psychotic episode service, the clinic for Specialized Treatment Early in...

[ Read more ](https://alert.psychnews.org/2015/02/program-for-first-episode-psychosis.html)

```json
{
  "@context" : "https://schema.org",
  "@type" : "BlogPosting",
  "author" : {
    "@type" : "Person",
    "name" : "Psychiatric News Alert",
    "url" : "https://alert.psychnews.org/author/psychiatric-news-alert"
  },
  "dateModified" : "2025-06-24T16:43:51.928Z",
  "datePublished" : "2013-10-29T04:00:00.000Z",
  "headline" : "Psych News Alert: FDA Approves Long-Acting Extended-Release Hydrocodone Formulation",
  "image" : [ "https://alert.psychnews.org/hubfs/Imported_Blog_Media/shutterstock_128350532-Jun-24-2025-04-42-02-5258-PM.jpg" ],
  "mainEntityOfPage" : {
    "@id" : "https://alert.psychnews.org/2013/10/fda-approves-long-acting-extended.html",
    "@type" : "WebPage"
  },
  "publisher" : {
    "@type" : "Organization",
    "logo" : {
      "@type" : "ImageObject",
      "url" : "https://alert.psychnews.org/hubfs/PN-Blue-Box.jpg"
    }
  }
}
```