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Dr. Bob is Robert Hsiung, MD,
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Posted by Phillipa on April 29, 2016, at 18:05:34
FDA Gives Final Approval to Abuse-Deterrent Xtampza ER
Pauline Anderson
| Disclosures | April 29, 2016
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EDITORS' RECOMMENDATIONS
FDA Gives 'Tentative' Approval to Abuse-Deterrent Xtampza ER
FDA Panel Recommends Approval of ER Abuse-Deterrent Oxycodone
Pain Management News & Perspectives
A twice-daily abuse-deterrent oxycodone medication (Xtampza ER, Collegium Pharmaceutical Inc) has received final US Food and Drug Administration (FDA) approval for the management of chronic pain requiring daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.The FDA gave a tentative approval for the New Drug Application in November 2015. The tentative approval followed a unanimous decision of its Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee in September 2015 to support licensing of the product for this indication.
The initial approval was tentative because while the FDA determined that the drug met all required quality, safety, and efficacy standards for approval, patent litigation filed last year by Purdue Pharma LP meant that it was subject to an automatic stay of up to 30 months, the company noted at the time in a statement.
A spokesperson for Collegium confirmed to Medscape Medical News that the litigation has now been disposed, and this represents final approval for the product.
Xtampza ER, Collegium's first product using its proprietary DETERx technology, is designed to provide adequate pain control while maintaining its drug release profile after being subjected to common methods of manipulation, including chewing and crushing.
In addition to having differentiated, abuse-deterrent properties, Xtampza ER also allows for flexible dosing in patients with difficulty swallowing. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which can be dangerous with currently marketed ER products.
During the advisory committee meeting, representatives from Collegium, based in Canton, Massachusetts, showed that the medication could be given by breaking open the capsule and pouring the oxycodone microspheres into a feeding tube or sprinkling them onto soft food or directly into the mouth.
Collegium plans to launch the new product in the United States in mid-2016 with five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg oxycodone hydrochloride."Abuse-deterrent opioids are a critical component to fighting the widespread national epidemic of prescription opioid abuse," commented Jeffrey Gudin, MD, director of pain management and palliative care, Englewood Hospital and Medical Center, New Jersey, in the Collegium press release. "The FDA approval of Xtampza ER is incredibly timely as abuse and misuse of opioids is at an all-time high."
Posted by Phillipa on April 29, 2016, at 18:07:10
In reply to FDA issures approval for new Opiod without abuse p, posted by Phillipa on April 29, 2016, at 18:05:34
According to docs comments under article they say that when there is a will there is a way. Phillipa
Posted by Horse on April 29, 2016, at 21:27:21
In reply to Re: FDA issures approval for new Opiod without abuse p, posted by Phillipa on April 29, 2016, at 18:07:10
Would tolerance be lessened, so that it's analgesic properties last at the same dose?
Posted by Phillipa on April 30, 2016, at 9:38:33
In reply to Re: FDA issures approval for new Opiod without abuse p » Phillipa, posted by Horse on April 29, 2016, at 21:27:21
It was a special news alert and this is the first I've heard of this. Maybe they don't know either. Seems like to avoid abuse issues or lessen them? Phillipa
Posted by baseball55 on April 30, 2016, at 21:09:03
In reply to Re: FDA issures approval for new Opiod without abuse p » Horse, posted by Phillipa on April 30, 2016, at 9:38:33
If it's an opioid, then tolerance will occur, necessitating increasing dosages. I think what's unique about this is that the time release can't be overridden by crushing or cooking it. Addicts aren't interested in slow, steady, low-level opioid release. They want drugs that give them an immediate euphoric sensation. Oxycontin did this when crushed and, when they changed the formula to make it harder to crush, addicts started cooking it.
So, presumably, the developers believe the time release can't be overcome. Of course, where there's a will.
Posted by Christ_empowered on April 30, 2016, at 23:22:10
In reply to Re: FDA issures approval for new Opiod without abuse p » Horse, posted by Phillipa on April 30, 2016, at 9:38:33
I guess...this is a good thing. A lot of Rx pill users are apparently switching to heroin. Its cheaper, from what I've read.I hope this will give people in need of serious pain relief what they need and maybe make some doctors a little more willing to do serious palliative care. Its strange...some docs are apparently turning into croakers, and others are stingy even with people who clearly need the Rx meds and won't cause any major problems.
Posted by Horse on May 1, 2016, at 0:10:14
In reply to Re: FDA issures approval for new Opiod without abuse p, posted by baseball55 on April 30, 2016, at 21:09:03
Sigh. As someone with chronic illness, I'm always looking for the golden ticket. Ultram ER (tramadol without tylenol) has been very good for about nine years without losing too much effectiveness, although, well, I think my health conditions have worsened some. Guess that's pretty good, although I don't know what I'll do in the future since anything over 400 shouldn't be prescribed. I take 200 mg. Tmi, I know. Just rambling.
Do you know if suboxine helps with pain? I hear it is very difficult to discontinue despite popular opinion, and the thought of physical dependence beyond what I have with tramadol isn't appealing.
> If it's an opioid, then tolerance will occur, necessitating increasing dosages. I think what's unique about this is that the time release can't be overridden by crushing or cooking it. Addicts aren't interested in slow, steady, low-level opioid release. They want drugs that give them an immediate euphoric sensation. Oxycontin did this when crushed and, when they changed the formula to make it harder to crush, addicts started cooking it.
>
> So, presumably, the developers believe the time release can't be overcome. Of course, where there's a will.
Posted by Phillipa on May 1, 2016, at 9:26:04
In reply to Re: FDA issures approval for new Opiod without abuse p » baseball55, posted by Horse on May 1, 2016, at 0:10:14
I heard on if you can believe TV which I don't watch that suboxine is also now being sold by those who are prescribed it so they can sell them and buy opiods. Didn't make a lot of sense to me. Oh this was on the TV show Intervention which is a good show. Phillipa
Posted by J Kelly on May 1, 2016, at 12:26:11
In reply to Re: FDA issures approval for new Opiod without abuse p » baseball55, posted by Horse on May 1, 2016, at 0:10:14
> Sigh. As someone with chronic illness, I'm always looking for the golden ticket. Ultram ER (tramadol without tylenol) has been very good for about nine years without losing too much effectiveness, although, well, I think my health conditions have worsened some. Guess that's pretty good, although I don't know what I'll do in the future since anything over 400 shouldn't be prescribed. I take 200 mg. Tmi, I know. Just rambling.
>
> Do you know if suboxine helps with pain? I hear it is very difficult to discontinue despite popular opinion, and the thought of physical dependence beyond what I have with tramadol isn't appealing.I, too, took Ultram for many years for an old auto injury. When tolerance forced me to switch, I went to Vicoprofen. I found that to be much harder to d/c than Ultram.
I also took Suboxone presumably for Parnate w/d (I was in a fog at the time). I remember feeling that it worked well on my headaches. It wasn't too difficult *for me* to discontinue.
http://www.ncbi.nlm.nih.gov/pubmed/24509068Good luck :)
Jade
Posted by baseball55 on May 1, 2016, at 19:25:39
In reply to Re: FDA issures approval for new Opiod without abuse p » baseball55, posted by Horse on May 1, 2016, at 0:10:14
> Do you know if suboxine helps with pain? I hear it is very difficult to discontinue despite popular opinion, and the thought of physical dependence beyond what I have with tramadol isn't appealing.
>The main ingredient in suboxone, buprenorphine, is an opioid and a pretty strong one. I got higher on suboxone then I had on oxycodone, when I was abusing it. So I imagine it would help with pain, just as any other opioid will. It stays in your system much longer than most other opiods, so that's a plus for pain relief. And it contains naloxone, an opiate antagonist, so virtually impossible to OD. But it is still restricted to prescribers with special suboxone training who can have no more than 100 patients on suboxone in their practice (up from 30 a few years ago). This would make it difficult to find a prescriber You can't just get it from your GP.
Also, because of the limits on prescribing, it is a goldmine for certified prescribers, so most don't take insurance and charge a small fortune for appointments (like $400 and up). Too bad, because it probably would be a good pain med.
This is the end of the thread.
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