An experimental drug could be a vital player in the plight to end the opioid epidemic.
It's known as VX-548, and its creator, Vertex Pharmaceuticals, said Tuesday the drug's use in late-stage clinical trials resulted in "clinically meaningful reduction in pain," without many of the risks associated with opioids.
In two trials, patients who had recently undergone surgery and received Vertex's painkiller had statistically significant pain relief over a 48-hour period compared to the placebo group.
A smaller study focusing on a wider range of pain conditions used the treatment for up to 14 days and also landed a positive result, with more than 83% of pain patients saying VX-548 was good to excellent at treating pain.
Vertex noted VX-548 was "safe and well-tolerated in all three studies," but it failed to work better than hydrocodone bitartrate/acetaminophen — the combination that makes up the opioid Vicodin — in post-surgery patients.
Still, the results of Vertex's trials pave a path toward gaining the U.S. Food and Drug Administration's approval, thereby providing the U.S. another pain treatment option outside of the dangerous world of opioids.
And Vertex plans to do so, saying it will submit a New Drug Application to the FDA by mid-2024 regarding VX-548's treatment of moderate-to-severe acute pain.
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Acute pain is typically brought on by something specific like surgery, broken bones, dental work or childbirth, according to Cleveland Clinic. It usually doesn't last longer than six months, going away when the underlying cause for the pain ends.
Despite acute pain affecting some 80 million Americans each year, there are limited treatment options, and often the treatment that's effective for one person may not work for another, a National Library of Medicine report says.
But that's not including opioids, considered the most potent painkillers that generally work for all patients. The downside is their addictive properties, and as opioid prescribing has grown exponentially in recent years, so has addiction to them. Their prominence has also spawned spikes in the use of synthetic opioids like fentanyl, which cause 150 overdose deaths each day, according to the CDC.
However, studies have shown that non-opioid treatments for acute pain can be just as if not more effective than opioids at treating some acute pain conditions, which could be where VX-548 comes in.
The oral medication works differently than opioids: It blocks pain signals before they reach the brain, unlike opioids that act on the brain itself.
Many other attempts to reduce pain targeting similar channels in the body have failed, but if Vertex's drug continues to be successful, it could introduce a new class of acute pain medicine for the first time in more than two decades, Dr. Jessica Oswald with Vertex said.
"As a physician treating patients suffering from pain for many years, I know firsthand the critical need for new, efficacious and safe treatment options," Oswald said. "The Phase 3 safety and efficacy across the three studies are impressive and demonstrate VX-548's potential to change the paradigm of pain management."
