According to US World News, Kentucky ranks in the top five
of states with the highest rates of opioid overdose deaths.1 In 2017
alone, 1,565 people in the state of Kentucky died from drug overdoses.1
Overdose deaths from heroin are declining, but drugs like fentanyl are taking
their place.1 As of Friday, November 2nd, the FDA
approved a new opioid painkiller known as Dsuvia. Dsuvia is a synthetic form of
sufentanil that is 10 times more potent than fentanyl and about 1,000 times
more potent than morphine.2
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Figure 1: Rate of Opioid-Related Overdose Deaths in Kentucky
vs. U.S. 1999-2016.3
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Sufentanil is an opioid analgesic and can be administered
intravenously, orally, or via epidermal route.4 Sufentanil acts by
selectively binding to Mu opioid receptors distributed in the brain, spinal
cord and other tissues throughout the body.4 Opioids achieve the
relief of painful symptoms by decreasing cAMP levels and neurotransmitter
release, allowing for membrane hyperpolarization.4 When the drug
binds to the opiate receptor, GTP is exchanged for GDP to inhibit the release
of nociceptive neurotransmitters such as GABA, acetylcholine and noradrenaline.4
Sufentanil also has a high bioavailability rate of 52% just
from a single sublingual tablet.4 Bioavailability rate is defined as
the degree and rate to which an administered drug is absorbed by the body. The
main sites of metabolism in the body include the liver and small intestine.4
* Dsuvia is available as 3 millimeter wide tablets to be administered
sub-lingual by healthcare providers in a hospital setting, or surgical center.5
The sublingual dose is intended to work by managing acute to severe pain in
adults. The company AcelRx projects $1.1 billion in annual sales of Dsuvia and
projects its availability in hospitals by early 2019.5
FDA Commissioner Scott Gottlieb justified their decision to
approve Dsuvia by saying, “The FDA is taking new steps to actively confront the
opioid epidemic, while also paying careful attention to the needs of patients
and physicians managing pain.”6 The Wall Street Journal published an
article agreeing with the FDA by arguing that Dsuvia is an ideal option for
wounded soldiers on the battlefield.2 This is because soldiers lack
access to intravenous injections or drip and a quick dissolving pill sub
lingual is much easier to administer.2
However, many physicians and researchers also disagree with
the FDA’s decision to allow another opioid on the streets. Dr. Raeford Brown
Jr, a professor of anesthesiology and pediatrics at the University of Kentucky,
stated “There is no good reason at this point in the US to put another opioid
on the streets.”2 In another article, Dr. Brown stated, “I have
strong feelings about the opioid crisis, as someone who lives in the Commonwealth
of Kentucky, where we continue to have people die.”5 Rather than
overprescribing these dangerous and addictive medications, physicians should
evaluate the efficacy and necessity of opioids. Without the concern of each
patient’s overall health and well-being, physicians are facilitating the opioid
crisis.
References:
1. Kentucky Drug Overdose Deaths Jump 11.5 Percent in 2017. US
& World Report News.
https://www.usnews.com/news/best-states/kentucky/articles/2018-07-25/kentucky-drug-overdose-deaths-jump-115-percent-in-2017.
Published July 25, 2018. Accessed November 11, 2018.
2. Satel S. The FDA Was Wise to Approve a New Opioid. The Wall
Street Journal.
https://www.aei.org/publication/the-fda-was-wise-to-approve-a-new-opioid/.
Published November 8, 2018. Accessed November 11, 2018.
3. Kentucky Opioid Summary. National Institute on Drug Abuse.
https://www.drugabuse.gov/drugs-abuse/opioids/opioid-summaries-by-state/kentucky-opioid-summary.
Published 2016. Accessed November 11, 2018.
4. Sufentanil. DrugBank. https://www.drugbank.ca/drugs/DB00708.
Published 2018. Accessed November 11, 2018.
5. Harper J. Despite Warnings, FDA Approves Potent New Opioid
Painkiller. National Public Radio.
https://www.npr.org/sections/health-shots/2018/11/02/663395669/despite-warnings-fda-approves-potent-new-opioid-painkiller.
Published November 2, 2018. Accessed November 11, 2018.
6. Goldschmidt D. Amid Deepening Addiction Crisis, FDA Approves
Powerful New Opioid. CNN.
http://www.wdrb.com/story/39412586/amid-deepening-addiction-crisis-fda-approves-powerful-new-opioid.
Published November 3, 2018. Accessed November 11, 2018.
Katie Flynn, A
Master’s in Medical Sciences Student, University of Kentucky
So I'm going to play devil's advocate here since knee-jerk reactions to anything seems to be the norm these days. Keep in mind some people are administered opioids and it is still not enough to control their pain. Especially for cancer patients in hospice. If there is an alternate drug out there some people may respond more positively to then I'm not so sure the government should restrict; especially if it can be controlled and administered in let's say a hospice or hospital setting only.
ReplyDeleteAs we know, all people respond to medications differently so being able to offer alternate medications to patients should still be a part of their overall treatment plan. With or without this added drug the opioid issue is not likely to go away. At this point producing an additional drug is not going to tip the scales, so long as sufentanil can be administered in a controlled setting by just patch or IV.
Similar to Jason, I try to look at this situation from both perspectives – while this does not seem like the best addition to the already troublesome drug problem in this country, I have some hope that it could potentially help a lot of people under the appropriate circumstances.
ReplyDeleteOriginally used to provide pain relief in treating extensive wounds on the battlefield, Dsuvia was intended to provide faster pain relief in traumatic injuries compared to intramuscular injections1 – which in my opinion would be greatly beneficial in those unbearable and unimaginable situations.
From what I’ve read it sounds like this drug will be intended for controlled use in healthcare settings – making it more difficult (not impossible) to be abused and easier to track/regulate due to its limited accessibility and usage.1
From soldiers out on the field, to patients in the emergency departments with traumatic injuries, to dying cancer patients with uncontrollable pain – I’d like to believe Dsuvia can potentially help offer relief and not wind up like another abused substance on the streets, only time will tell.
Burke, J. (2018, November 21). Opioid Hysteria and the Demonizing of Dsuvia. Retrieved from https://www.painnewsnetwork.org/stories/2018/11/21/opioid-hysteria-and-the-demonizing-of-dsuvia
It does seem counterintuitive to develop new opioids while the problem of opioid addiction only seems to be getting worse. However, I do agree that drugs like Dsuvia could be beneficial to some patients in very specific and controlled settings.
ReplyDeleteWhile doing some research on the opioid epidemic, I can across an interesting fact. About 46% of opioid-related overdose deaths in 2016 involved synthetic opioids such as fentanyl, while 40% involved prescription drugs. Even though this drug can be obtained with a prescription, the increase in fentanyl overdose deaths is thought to be due to illicit production and distribution outside the country rather than pharmaceutical fentanyl that is being diverted or misused. I wonder if this will be the case with sufentanil as well. It seems that its use will be highly regulated, so I anticipate that the real trouble with be with illicit manufacturing of the drug.
Lieber, M. (2018, May 01). Synthetics now killing more people than prescription opioids, report says. Retrieved from https://www.cnn.com/2018/05/01/health/fentanyl-opioid-overdose-study/index.html
Opioid Overdose. (2016, December 16). Retrieved from https://www.cdc.gov/drugoverdose/data/fentanyl.html
With the opioid epidemic being a national crisis, I cannot believe the FDA approved yet another opioid. After doing my presentation on Cox-2 inhibitors, I am really confused as to why physicians are prescribing their patients with an opioid, accompanied with a cox-2 inhibitor. Because there have been studies that have shown chronic use of cox-2 inhibitors leading to cardiovascular and gastrointestinal risks, why not at least use this as a solution to manage acute pain instead of going straight to just an opioid by itself?1 Like I had also previously discussed, opioid-sparring can even be more effective in pain management than just prescribing an opioid by itself.2 When the opioid, morphine was accompanied with the cox-2 inhibitor, Valdecoxib, regardless of dosage amount, it had resulted in a lower maximum pain daily intensity in comparison to just giving the patients morphine and the placebo.2 The researchers were able to successfully manage the pain, as well as reduce the amount of opioid used.2 These two positive results seem to be like a win-win to me. I would like to see more being done about this opioid crisis because from what I am seeing, it just seems like we are digressing.
ReplyDeleteReferences:
1.) Cheng, Y. et al. Cyclooxygenases, microsomal prostaglandin E synthase-1, and cardiovascular function. Journal of Clinical Investigation 116, 1391–1399, https://doi.org/10.1172/jci27540 (2006).
2.) Reynolds LW, Hoo RK, Brill RJ, North J, Recker DP, Verburg KM. The COX-2 Specific Inhibitor, Valdecoxib, Is An Effective, Opioid-Sparing Analgesic in Patients Undergoing Total Knee Arthroplasty. Journal of Pain and Symptom Management. 2003;25(2):133-141. doi:10.1016/s0885-3924(02)00637-1.
After discussing the FDA's approval of Dsuvia in class, it seemed irresponsible to me that they would put another opioid on the market and the way they went about it was pretty shady. Hopefully, its strict availability will prevent its abuse, but as Caitlin said, it is not impossible and people will find a way. Dsuvia was originally rejected by the FDA in October 2017, citing issues of safety and directions for use. Even now, questions about Dsuvia's efficacy remain. It has only been compared to placebo and not lower-risk painkillers like acetaminophen or even morphine (Al Idrus, 2018). Despite its approval, medical professionals are not fully convinced about the use of Dsuvia.
ReplyDeleteIn light of the opioid crisis, I wonder if regulation of controlled substances needs to be modified. In 2012, Kentucky passed House Bill 1 which expanded the Kentucky All Schedule Prescription Electronic Reporting (KASPER) system and required all prescribing providers to register. It also requires that licensure boards immediately investigate prescribing complaints. House Bill 333 explicitly defines fentanyl-related felonies (Kentucky Office of Drug Control Policy, n.d.), but new legislation will be needed to keep up with the growing opioid market after the approval of Dsuvia.
I think now more than ever it is important to keep physicians trained on opioid prescribing practices and up-to-date with alternative pain options. The CDC recommends nonpharmacological and nonopioid pain treatments for patients. Even when opioids are prescribed, they suggest they be used in conjunction with nonpharmacological treatments. Clinicians should be very clear with their patients about the risks of opioid use and take responsibility to monitor their patients' conditions and progress (Centers for Disease Control and Prevention, n.d.).
Al Idrus, A. (2018, October 15). 1 year after FDA snub, advisory committee recommends AcelRx's Dsuvia for approval 10-3. FierceBiotech. Retrieved from https://www.fiercebiotech.com/biotech/1-year-after-fda-snub-adcomm-recommends-acelrx-s-dsuvia-for-approval-10-3
Centers for Disease Control and Prevention. (n.d.). Guidelines for Prescribing Opioids for Chronic Pain. Retrieved from https://www.cdc.gov/drugoverdose/pdf/Guidelines_Factsheet-a.pdf
Kentucky Office of Drug Control Policy. (n.d.). Legislative Initiatives. Retrieved December 4, 2018, from https://odcp.ky.gov/Pages/Legislative-Initiatives.aspx
I always try to be as objective as possible in my writing, but hearing about Dsuvia made me very angry. A drug company could have been developing a novel treatment for mental illness, Alzheimer's, or cancer, but they decided to put out a NEW opioid that is stronger than any on the market currently? It quite frankly disgusts me. I read an article about Dsuvia in Popular Science, and one of its main uses was going to be pain relief on the battlefield. However, there are already drugs like this that are being used (Popular Science, 2018). Also, the article included a very good quote from Dr. Raeford Brown whom we discussed in class: “Lack of historical ability of the FDA to enforce controls, the pharmacologic potency of the drug, and the ease with which this drug will be diverted are some of the reasons that I would never consider this product for marketing in the U.S.” (Popular Science, 2018) He pretty much sums up all of my feelings about this drug. Although it is only meant for hospital or military use, we all know how this is going to end up. It will be diverted from hospitals, people will get addicted to it, and will die. The fact that this drug was even put into development and approved is incredibly stupid and beyond my comprehension. I want my tax dollars back, please and thank you.
ReplyDeleteReference:
Mock, J. (2018, November 06). Do we need an opioid 1,000 times more powerful than morphine? The FDA thinks so. Retrieved from https://www.popsci.com/fda-new-opioid-dsuvia
I am quite conflicted on this issue. On one hand, I agree that we need viable treatments for uncontrollable pain experienced by soldiers on the battlefield or by terminal cancer patients. At the same time, I feel quite pessimistic that this drug or other analogs of this drug will come to be abused. I agree with Jon and others that the FDA should have sided with the majority of the physicians who all voice strong opposition towards the approval. I just hope that increased awareness, dialogue and regulation of the opioid use in recent years will help curb future abuse.
ReplyDeleteThe opioid crisis is clearly a very pressing matter that needs to be better addressed at the legislative level. Most prescription drug diversion (defined as the illegal transfer of a pharmaceutical from a legitimate source to an illicit one) starts with a doctor's prescription (1); that is to say, most of the opioids that end up on the black market originally came from legitimate prescriptions. So while there are many facets of this problem that need to be addressed in tandem (non-opioid alternatives for addicts in pain, evidence-based solutions for treating addiction, etc), I think it starts with laws surrounding prescribing opioids. The implementation of KASPER in 2012 was a step in the right direction, but that really mainly targets the prevention of patients with valid opioid prescriptions from filling new scripts too soon (although it can also help, to a lesser degree, in identifying red flags indicating possible forgery).
ReplyDeleteAccording to the FDA Advisory Committee Breifing on Dsuvia, it is to be administered to the patient "only by a healthcare professional" with distribution limited to "only REMS-certified medical institutions/healthcare facilities." (2) They list hospitals, same-day surgery centers, and procedural clinics treating acute moderate-to-severe pain as settings which would potentially qualify to become REMS-certified and further specify that the healthcare facility must have "access to equipment and personnel trained to detect and manage hypoventilation, including use of supplemental oxygen and opioid antagonists, such as naloxone," "already be administering IV opioid analgesics," and "have processes/procedures in place to ensure DSUVIA is not dispensed for use outside of the certified healthcare facility." (2)
So in light of these requirements, I agree with the FDA's decision to approve the use of this drug for patients with severe breakthrough pain. I think, in general, there needs to be more regulation/restriction when it comes to prescribing opioid analgesics, but I think Dsuvia actually did their due diligence in this regard.
References:
1) https://www.pharmaceutical-journal.com/opinion/comment/the-prescription-opioid-addiction-and-abuse-epidemic-how-it-happened-and-what-we-can-do-about-it/20068579.article?firstPass=false
2) https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM622858.pdf
Just as everyone else has explained, I, too, am pretty conflicted on this topic. Pain management is one of the most, if not the most trivial disorder to approach. I understand where people are coming from when they explain their reasoning for being anti-dsuvia. There are so many diseases and disorders that desperately need attention and research in order to develop a treatment. However, we are learning so much more about opioids, which allows us to develop better treatment plans and strategies. It appears that this drug is going to be administered under extremely tight regulation because the drug will only be available in medically supervised settings. This newly developed opioid could be a positive break-through in the pain management world, especially in wounded soldiers. A more potent drug generally results in a strict dose prescribed by physicians, which can potentially reduce the risk of misuse or abuse. I am equally as concerned about adding to fuel to the already very large opioid crisis fire, but all we can do is hope that the FDA and health care professionals have a hold on this as they say they do.
ReplyDeletehttps://abcnews.go.com/Health/dsuvia-opioid-painkiller/story?id=58875487
It really upsets me that there is even a thought about a new opioid given the current crisis we have in our country. Especially given the way this one is being streamlined into clinical trials. This brings to light the thought that everyone has; pharmaceutical companies make money off of our sicknesses so why would they try to completely eradicate them? Because although addiction could be caused by an initial choice, it still doesn’t negate the fact that it is a sickness that some people can’t get rid of. I can only hope that the analgesic/anti-withdrawal compound AT-121 that I stated in my blog gets the funding that it needs to help combat this epidemic while still treating people. That last update on August 29th stated that the drug has been effective in monkeys, so the next step will be the clinical trials to test safety and efficacy. One can only hope that the results in the animal model will carry over to humans so that we can have a way to combat this epidemic.
ReplyDeleteSource:
Kimberly Hickok. (2018). “Non-addictive Opioid Alternative Shows Promise in Monkey Study”. Live Science, Aug 29, 2018.
It's really frightening to think about another opioid(like) available in the market where there's already opioid abused previously. But looking at the bright side I can guess this drug potentially can be a very good choice for drug addiction withdrawal.
ReplyDelete