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Vertex Prepares to Submit New Drug Application for Medication to Treat Acute Pain
Vertex Pharmaceuticals on Tuesday announced positive results from its Phase 3 program for its selective NaV1.8 inhibitor, known as VX-548, to treat moderate-to-severe acute pain and said it plans to submit a new drug application to the US Food and Drug Administration by mid-2024. If approved, the drug could serve as an alternative to potentially addictive opioid medications that are prescribed to treat pain.
“We are very pleased with the results from the VX-548 pivotal program, which demonstrate a compelling and consistent combination of efficacy and safety across multiple acute pain conditions and settings,” Vertex CEO and President Reshma Kewalramani, MD, said in a news release. “The VX-548 benefit-risk profile ideally positions it to potentially fill the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.
“With FDA breakthrough and fast track designations in hand, we are working with urgency to file the new drug application for VX-548 and bring this non-opioid medicine to the millions of patients who suffer from acute pain each year in the US.”
The Phase 3 program included 2 trials—both randomized, double-blind, placebo-controlled—with 1 trial following abdominoplasty surgery and the other following bunionectomy surgery, as well as a single-arm safety and effectiveness study that included patients with a wide range of surgical and non-surgical pain conditions.
In the trials following abdominoplasty and bunionectomy surgeries, treatment with VX-548 produced statistically significant improvements in the time-weighted sum of pain intensity difference from 0 to 48 hours (SPID48) compared to placebo, as well as a clinically meaningful reduction in pain intensity from baseline at 48 hours on the Numeric Pain Rating Scale (NPRS).
In a test of its hypothesis that VX-548 was superior to hydrocodone bitartrate/acetaminophen on SPID48 following abdominoplasty or bunionectomy surgery, neither trial met this key secondary endpoint. In a measure of the second key secondary endpoint of both trials—time to meaningful pain relief in NPRS (defined as a reduction by 2 or more points) from baseline compared to placebo—VX-548 had a median time to meaningful pain relief of 2 hours in abdominoplasty and 4 hours in bunionectomy, compared to 8 hours for placebo in both trials.
In the Phase 3 single-arm safety and effectiveness study, VX-548 demonstrated favorable safety and tolerability, as well as effectiveness at the end of treatment.
“The Phase 3 safety and efficacy across the 3 studies are impressive and demonstrate VX-548’s potential to change the paradigm of pain management,” Jessica Oswald, MD, MPH, associate physician in emergency medicine and pain medicine, University of California San Diego, and Vertex Acute Pain Steering Committee member, said. ”I look forward to the potential of having a new class of acute pain medicine—the first in more than 2 decades—to use as an alternative to opioids to help the millions of people impacted by acute pain.”
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