April 15, 2024

An experimental drug may very well be a significant participant within the plight to finish the opioid epidemic.

It is referred to as VX-548, and its creator, Vertex Prescription drugs, stated Tuesday the drug’s use in late-stage medical trials resulted in “clinically significant discount in ache,” with out lots of the dangers related to opioids.

In two trials, sufferers who had lately undergone surgical procedure and obtained Vertex’s painkiller had statistically important ache reduction over a 48-hour interval in comparison with the placebo group. 

A smaller research specializing in a wider vary of ache situations used the remedy for as much as 14 days and likewise landed a optimistic outcome, with greater than 83% of ache sufferers saying VX-548 was good to glorious at treating ache. 

Vertex famous VX-548 was “protected and well-tolerated in all three research,” nevertheless it did not work higher than hydrocodone bitartrate/acetaminophen — the mixture that makes up the opioid Vicodin — in post-surgery sufferers. 

Nonetheless, the outcomes of Vertex’s trials pave a path towards gaining the U.S. Meals and Drug Administration’s approval, thereby offering the U.S. one other ache remedy choice exterior of the harmful world of opioids.

And Vertex plans to take action, saying it is going to submit a New Drug Software to the FDA by mid-2024 concerning VX-548’s remedy of moderate-to-severe acute ache.

Acute ache is often introduced on by one thing particular like surgical procedure, damaged bones, dental work or childbirth, in line with Cleveland Clinic. It normally does not last more than six months, going away when the underlying trigger for the ache ends. 

Regardless of acute ache affecting some 80 million People every year, there are restricted remedy choices, and sometimes the remedy that is efficient for one particular person might not work for an additional, a Nationwide Library of Drugs report says. 

However that is not together with opioids, thought of probably the most potent painkillers that typically work for all sufferers. The draw back is their addictive properties, and as opioid prescribing has grown exponentially lately, so has dependancy to them. Their prominence has additionally spawned spikes in using artificial opioids like fentanyl, which trigger 150 overdose deaths every day, in line with the CDC.

Nonetheless, research have proven that non-opioid therapies for acute ache may be simply as if no more efficient than opioids at treating some acute ache situations, which may very well be the place VX-548 is available in.

The oral remedy works in another way than opioids: It blocks ache alerts earlier than they attain the mind, in contrast to opioids that act on the mind itself.

Many different makes an attempt to scale back ache focusing on related channels within the physique have failed, but when Vertex’s drug continues to achieve success, it may introduce a brand new class of acute ache medication for the primary time in additional than 20 years, Dr. Jessica Oswald with Vertex stated.

“As a doctor treating sufferers affected by ache for a few years, I do know firsthand the crucial want for brand spanking new, efficacious and protected remedy choices,” Oswald stated. “The Section 3 security and efficacy throughout the three research are spectacular and show VX-548’s potential to vary the paradigm of ache administration.”


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