Volume 95 Issue 25 | p. 8 | News of The Week
Issue Date: June 19, 2017 | Web Date: June 14, 2017

FDA takes aim at opioid epidemic

Agency wants to pull opioid from market because it says the drug’s benefits don’t outweigh its risks
Department: Science & Technology
Keywords: molecule of the moment, drug safety, opioid epidemic, oxymorphone, FDA, drug formulation

The U.S. Food & Drug Administration has requested that Endo Pharmaceuticals remove its painkiller Opana ER from the market. Opana ER’s active ingredient, oxymorphone, is an opioid similar to morphine but with an added hydroxyl group that makes it 10 times as potent. The agency says this is the first time it has taken steps to halt sales of an opioid over concerns of public abuse. In 2012, Endo reformulated Opana ER to make it harder for people to crush the drug, and thereby snort it, and to dissolve the drug, and thereby inject it. The firm did so with help from German drugmaker Grünenthal’s Intac technology, which uses a high-molecular-weight polyethylene oxide and proprietary excipients to make it difficult to break the pills into fine particles and to make them gel when dissolved. Still, people with opioid addiction have figured out ways to inject it, and FDA says illicit use of Opana ER has been associated with an outbreak of HIV and hepatitis C. “We are facing an opioid epidemic—a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said newly appointed FDA commissioner Scott Gottlieb in a statement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits.” Endo says it’s currently evaluating its “full range” of options.

 
Chemical & Engineering News
ISSN 0009-2347
Copyright © American Chemical Society
Comments
Dr.Sabatino Nacson (Wed Jun 14 15:04:43 EDT 2017)
Another more direct way is to stop the flux of these drugs from China and Mexico using non-invasive technologies like what we developed at Teknoscan (see web site). It allows screening of marine containers, cars crossing the border etc. for many of the drugs and the latest Fentanyl and its many analogues. These tools were developed and commercialized in 2012 in Canada and are available to assist Customs and border authorities to intercept these packages coming to the country.
Our trace chemical detector allows detection of all types of drugs and explosives on one sample acquired from an enclosure or other suspected containers.
Christine Ackal RPh (Thu Jun 15 08:47:38 EDT 2017)
Such an intelligent welcoming message!
 I am a pharmacist in Louisiana and totally disagree with the current efforts of the FDA to control the opioid epidemic.
The FDA is not making the patient that overdoses accountable for their actions.
The FDA should spend a day in a pharmacy and take a look at the patients that are in chronic pain.
The DEA says we should do everything possible to avoid drug diversion without impeding patient care.
Trust me when I tell you that the drug addicts that are overdosing will find what they are looking for.
Take opioids off the market and they will turn to Heroin. Something they have no control over.
The people who overdose will find a new drug of choice. I never wish harm on anyone but I do pray these members
restricting chronic pain patients from getting their medicine are never in their position.
They should get out of their offices and find out what is really going on.
Stop blaming the drug companies, physicians, and pharmacists.
They are just the FDA's scapegoat for not actually doing their job.
My suggestion is to continue to monitor opioid use, urine test, medication management, PMP monitoring mandation,
count pill by pharmacist and physicians before refill, and signing a contract stating discharge if another prescriber
issues pain medication.
This is not real difficult, chronic pain patients are suffering!
Dr. J Richard Mayer (Wed Jun 14 15:20:50 EDT 2017)
Good for the FDA !!!!!!! We need to take actions of all kinds that make sense and that protect society from drug abuse - if we can. Some will argue that FDA and other government agencies do hot have the right or the authority to do this. But I as a chemist (PhD in organic chemistry from Yale University) strongly agree with this FDA action and would argue that we must protect and preserve the independence of FDA and its ability to control big pharma - isn't that one of the key goals of FDA?
Natasha Eddleman (Fri Jun 16 00:34:23 EDT 2017)
As someone who suffers from chronic back pain (DDD with herniation, spurs, facet stenosis) radiculopathy) who is prescient this medication, I do not agree with this. Most of the opioid addicts I've ever met, heard of, known haven't even heard of this med. It's all about loritab, oxycodone, percocet, etc. In other words, the cheaper, more widely available and over-prescribed drugs. I've been given rx of several different meds (including Fentonyl patch, which I didn't like at all) and Opana is the only med that has actually treated my pain and without making me feel 'altered'. My husband is also on this me for two herniated discs with radiculopathy, due to a fall at work, and agrees with me on this matter. So go after the other medications. The ones whose manufacturers aren't already taking measures to help stop abuse.
Natasha Eddleman (Fri Jun 16 22:43:11 EDT 2017)
Auto correct makes things so interesting sometimes...I am 'prescribed' this med, not 'prescient'.
Bill (Wed Jun 14 15:47:43 EDT 2017)
Gee, opium is addictive. Who could have seen that coming? I hope we get back to the good old days when pharmakea drugs are highly addictive but their narcotic effects are not as pronounced as opium.
Paintrain (Fri Jun 16 10:28:58 EDT 2017)
There are more medications out their that last 12hrs & some more potent then this drug. I know there is an epidemic of abuse. But what do you want people who are disabled & in severe pain every day to the point they can't get up without the medication. Cancer, Neurofibromatosis, RSD, Chronic Severe Pain, Fibromyalgia & I can't list many more. Not everyone can handle pain the same way & many like myself are allergic to other medications. This is the only one I am not allergic to & there is a generic of this & so many others that addicts can abuse so why go after just this one? I am not saying this so you can go after each one, I am just speaking for the people who are in real pain. We can't afford to go to the hospital everyday crying let alone drive there when you are in so much pain. More people kill themselves over pain that they had for years then anything else. A drug addict will not just pick this medication to try to use it in any manner possible just to get high they will go after the cheap ones & i for one know these are not cheap since I see my insurance bill. I understand there is an big problem with opiod & herion abuse but to get rid of the medication people who really need it will not solve the problem they will still find a way to get what they want. If this drug goes away they find another. Why are you not focusing on who is making the new herion drug I saw in TV called Gray Death that is killing many people? I am scared to go out to a public place for fear they could have used the bathroom to do it & if I get a spec of it on my hands I could die! Where are they getting the ingredients to make such a high potent drug. That scares me more. I agree with that fact that there is a big drug problem with people who misuse but for the ones who do not & really truly need it what should they do? Suffer? You have to look at the entire picture from both sides. I just don't understand why anyone would be so stupid to misuse them if they need them but I do if they are an addict. It also took me 5 yrs of crawling on the floor crying & screaming before I even would touch anything besides Advil which is worse in your liver also & I lock all my medication no matter what is is up in a fire box just in case my grandkids or anyone can't accidentally take them. Even heart medication. I just want to be a voice for the people who have no choice that are truly in pain & can not take other medications.
Natasha Eddleman (Fri Jun 16 22:59:57 EDT 2017)
I am so with you! We lock our meds up too and don't even have children in the house. You have re-voiced my opinion...what are those of us to do whom this drug helps, who don't abuse it, have proper dose prescribed, and have tried other meds that don't help or we're allergic to?! I'm trying to find if this actually has a docket # so I can contact the FDA in the way they specify. And when I do, it'll be spread everywhere I can get it...pharmacies, doctor offices, places where people in our position can take & use the info to spread their voice too.
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