Amid Opioid Crisis, FDA Approves Deadliest Painkiller Yet

America is in the midst of the worst opioid epidemic in its history, and what’s most alarming is that the drugs most complicit in the plague of addiction and overdoses are perfectly legal and available in most pharmacies, including cough syrup, fentanyl, oxycodone, and others. Now, instead of holding back this epidemic, an opioid stronger than anything we’ve ever known may well be making its way to the market.

Dsuvia is a powerful painkiller that was approved by the FDA last year for use in supervised settings, such as ERs, specifically for use in cases of severe physical trauma, such as a broken bone or gunshot wound.

Just how strong is this stuff? Dsuvia is about 10 times stronger than fentanyl and 1,000 times more powerful than morphine!

But hold on, if Dsuvia has been approved for hospital use only, then what’s the problem anyway?
The problem is twofold: drug diversion and misprescription, both potentially leading to lethal results.

Drug diversion is the umbrella term for illegal use of legally-prescribed medicine for any use that is not the one it was intended for. Obtaining such prescription drugs is achieved by criminals in several ways, including “doctor shopping” - the act of visiting a doctor with false health complaints and with the intent of receiving a specific opioid prescription, theft and forged prescriptions.

Misprescription is the act of prescribing either the wrong drug or the wrong dose. This can be especially disastrous in the case of opioids that are extremely potent and addictive. According to a recent study, between 35% and 55% of patients that are prescribed fentanyl are actually opioid intolerant. For reference, fentanyl accounts for about half of overdose-related deaths in the United States.

Because Dsuvia comes in small, soluble tablets, medical experts are worried it will be easier to divert and abuse. And there does not seem to be any serious medical need for it, either, as the same drug already exists in hospitals in injectable form.

And one cannot simply ignore the market forces at play in creating the current health crisis, as drug manufacturers have every commercial reason to encourage sales by decreasing costs, advertising the drugs and fiddling with prescription practices to make the drug easier to obtain. There is no reason to believe Dsuvia will be any different, as its distribution will be monitored by the manufacturer, AcelRX.

Dsuvia will be regulated in accordance with the FDA’s REMS (risk evaluation and management strategies) program for the monitoring of high-risk drugs, but before you take a sigh of relief, consider that the lethal fentanyl is also monitored by the same program, proving REM’s limited efficacy in stopping the abuse of dangerous opioids.

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New painkillers that cut overdose risk

A team of scientists has come up with new opioid pain relievers that not only reduce pain on par with morphine, but also reduce overdose risk.

The  research described a method for making safer opioid painkillers. According to the research many people die every day from opioid overdoses - deaths caused when opiates like oxycontin, heroin and fentanyl slow and eventually stop a person's breathing.

Researcher said that the study shows that a range of compounds can deliver pain-blocking potency without affecting respiration.

The study builds on two decades of research by researchers, who long questioned whether the painkilling pathway, called the G protein pathway, could be unlinked from the breathing suppression pathway, called the beta-arrestin pathway.

For the study, the researcher worked closely with a chemist  to develop new potential drug molecules; they then tweaked their chemical structures to systematically vary the "bias" between the two pathways--G protein signaling and beta-arrestin recruitment. The group developed more than 500 compounds in the past six years, and they found more than 60 that showed bias between signaling assays. They then selected six compounds to represent a wide range in the degree of bias (from those that preferred barrestin2 recruitment to those that almost exclusively preferred G protein signaling) and determined their overall potency for inducing analgesia and respiratory suppression in mouse models.

The researchers found that the new compounds could indeed enter the brain--and all of the compounds were as potent, if not more so, than morphine. The compounds that were less able to promote barrestin2 associations in cells were also less likely to induce respiratory suppression in mice.

In contrast, the painkiller fentanyl was shown to prefer receptor-barrestin2 associations and also had a more narrow safety margin. In short, the fentanyl dose needed to alleviate the perception of pain was closer to the dose that suppressed breathing, which may be why fentanyl is more likely to trigger respiratory suppression at low doses. Fentanyl is a powerful pain killer, but one with a narrow therapeutic window and a history of overdoses. While this issue requires more research, "this at least brings into question whether this may be part of the reason," he said.

He explained that separating the receptor's ability to engage in the two pathways can provide a way to separate desired drug effects from side effects.

THIS IS ONLY FOR INFORMATION, ALWAYS CONSULT YOU PHYSICIAN BEFORE HAVING ANY PARTICULAR FOOD/ MEDICATION/EXERCISE/OTHER REMEDIES.   

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