Sufentanil and Alternative Facts

It’s bad enough that mainstream media and politicians continue to spread false information regarding the opioid epidemic, with key blame placed on the shoulders of Big Pharma, and without consideration to other important influences.  For example, managed care and third-party payers prefer the most abusable immediate release opioids over safer alternatives like buprenorphine (buccal, branded as Belbuca and transdermal, branded as Butrans), tapentadol, and of course the abuse deterrent formulations of which there are several, all in an effort to maximize profit and without regard to safety.  Also, opioid prescribing and overall daily doses have drastically declined since 2015, yet politicians, peer reviewed literature and mainstream media continue to begin their rhetoric verbally and in writing, with data “from 1999 to present” and without consideration to contemporary data dating 2015 to present. And aside from this, managed care dictates what non-medication therapies a patient can receive, and how many visits, if any, such as physical therapy, cognitive behavior therapy, chiropractor, to name a few. But, the focus of this post is not about politics or managed care greed, as there is plenty of that on my previous posts.

Today I focus on an article posted by Anesthesiology News from 9/7/2019 entitled “Study Maps IV Morphine Equivalence of Sublingual Sufentanil”.  The article was intended to provide an update on two sublingual sufentanil tablet (ssT) products, Zalviso and Dsuvia (both manufactured by AcelRx Pharmaceuticals), the latter of which was approved for use in the US last November for acute pain with very strict access guidelines and availability only within acute care settings such as operating rooms and emergency rooms. Zalviso is a similar product available in Europe but not yet in the US; it is a unique device that can be used post-operatively in the form of patient controlled analgesia, a popular pain management technique generally employing morphine or hydromorphone so that patients have control over their as needed pain medication doses post-operatively.

The Anesthesiology News article written by Ethan Covey included a few statements from presumed experts. Dr. Eric Michael of the State University of New York (SUNY) Upstate Medical Center was one of the interviewees. I’m going to give him some leeway, because according to the article he is a fellow, which indicates less life experience as a physician. Also, his training according to the article is in interventional pain management, which focuses on various techniques (e.g. facet joint injections, nerve blocks,  neuroaugmentation,  vertebroplasty, kyphoplasty, nucleoplasty, endoscopic discectomy, implantable drug delivery systems), but that does not ensure expertise in complex and advanced pain pharmacotherapeutics.

The author, Mr. Covey, gets a flunking grade for not checking the facts! The statement quoted from Dr. Michael in the article is “…while the sublingual formulation may help improve the efficiency of pain management in the emergency room or outpatient surgical center, the ease of administration will make it a popular drug of abuse if it makes its way to the black market. … IV fentanyl is also not available for outpatient use, and somehow it seems to have made its way onto the streets. How can they be so sure the same won’t happen with sublingual sufentanil?” This statement is so inaccurate, I’m sitting here pulling my hair out.

Here are the facts…

• IV fentanyl HAS NOT “made its way onto the streets” as suggested by Dr. Michael. IV prescription fentanyl almost, or perhaps NEVER makes it to the streets, and there is plenty of data to support that.
• Pharmaceutical fentanyl that does make it to the streets is relatively rare, and when that happens, it is NOT fentanyl from the IV formulation we see in hospitals, as Dr. Michael suggests. Instead, it is from various dosage forms that ARE prescribed for outpatient use outside the hospital such has transdermal fentanyl, or various sublingual forms like Actiq and others which are collectively known as TIRFs (transmucosal immediate release fentanyls). Still this is relatively rare compared to other abusable prescription opioids.
• Dr. Michael is correct that “…the sublingual formulation may help improve the efficiency of pain management in the emergency room or outpatient surgical center”.
• Illicit, non-pharmaceutical grade BOOTLEG FENTANYL DERIVATIVES ARE on the streets.  These are not FDA approved products and they are imported from other counties, most notably China. This is nicely outlined by Bettinger and colleagues in Fentanyl; Separating Fact from Fiction.

If Dr. Michael and Mr. Covey want to make a fair comparison for the likelihood of sufentanil sublingual tablet diversion, they should compare it to other pharmacologically and therapeutically similar products that are ONLY AVAILABLE within institutions and that are NOT available by outpatient prescription.  Those drugs are NOT fentanyl; they are alfentanil and remifentanil.  I am not aware of any single instance where either of these two drugs have been diverted or are commonplace on the streets.

Once again, we have an article that provides false information which could contribute to further rhetoric by politicians and media muckrakers. I hope this will provide clarity on the alternative facts as published by Anesthesiology News.

Comments, as always are welcome!