Pictured: Vertex Pharmaceuticals office in Boston, Massachusetts/iStock, hapapapa
Vertex Pharmaceuticals announced Tuesday that its non-opioid pain treatment VX-548 completed three Phase III studiescausing significant pain reduction in surgical and non-surgical settings.
Two of those late-stage studies evaluated VX-548 in patients who had undergone either abdominoplasty — also known as abdominoplasty — or bunionectomy, which is a corrective procedure to remove a bony deformity in the toes. In both cases, the candidate was primarily evaluated according to the weighted sum of pain intensity difference from 0 to 48 hours after surgery (SPID48).
Compared with placebo, VX-548 improved SPID48 scores among abdominoplasty patients, an effect that was highly statistically significant with a p-value of less than 0.0001, according to the Vertex release. The non-opioid pain reliever had a similarly strong effect in the bunionectomy trial, with a p value of 0.0002, the company said.
Both abdominoplasty and pneumonectomy patients also reported a “clinically significant reduction in pain” 48 hours after VX-548 treatment, as measured by the Numerical Pain Rating Scale (NPRS).
In addition, VX-548 showed a more rapid onset of substantial pain relief than placebo. Abdominoplasty patients reported that they felt the pain treatment was working after a median of two hours, whereas the median onset in the bunionectomy study was four hours. In comparison, those who received a placebo experienced pain relief after a median of eight hours.
Vertex’s third Phase III study, a single-arm safety and efficacy trial, also showed that VX-548 was effective in relieving a variety of surgical and nonsurgical pain. Using the Patient Global Assessment tool, 83.2% of patients surveyed said Vertex’s candidate was good, very good, or excellent in treating their pain.
“VX-548’s benefit-risk profile positions it ideally to fill the gap between well-tolerated but limited efficacy drugs and opioid drugs with therapeutic efficacy but known risks, including the potential for addiction,” said Vertex CEO Reshma Kewalramani.
With that data in hand, Vertex is “working urgently” to submit a new drug application for VX-548, Kewalramani added. The company expects to file its application by mid-2024, seeking broad labeling for moderate to severe acute pain.
Vertex is also targeting a broad label for VX-548 in peripheral neuropathic pain, for which the company published promising Phase II data in December 2023. In patients with diabetic peripheral neuropathy, 12 weeks of VX-548 treatment resulted in significant reduction in self-reported pain as measured by the NPRS. Vertex is now preparing to move VX-548 into central development for this indication.
Designed to be orally available, VX-548 is a selective inhibitor of the voltage-gated sodium channel blocker NaV1.8, which is a key player in peripheral pain signaling. In August 2023, Vertex spokeswoman Heather Nichols said BioSpace that VX-548 could open up the first new class of pain treatments in more than two decades.
“We believe we could redefine pain treatment with the first new mechanism of action in decades,” Nichols said at the time.
Tristan Manalac is a freelance science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
