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Vertex Presents Phase 3 Data on Nonopioid Suzetrigine to Treat Acute Pain at Anesthesiologists' Annual Meeting
The FDA has set a PDUFA date of January 30, 2025 for the investigational oral nonopioid therapy for acute pain, which could be a first-in-class win for Vertex.
Suzetrigine, the investigational oral, highly selective NaV1.8 pain signal inhibitor for the treatment of acute pain in development by Vertex, was highlighted during 2 oral presentations at the annual meeting of the American Society of Anesthesiologists (ASA), taking place from October 18-22, 2024, in Philadelphia, PA, according to a company news release.1
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The presentations, one held during the “Best Abstracts” session on Sunday, October 20, marked the first time suzetrigine phase 3 data were presented to the medical community.1 The company made its original announcement of the positive data in January of this year.2
The FDA granted Fast Track and Breakthrough Therapy designations to suzetrigine in July.3 The novel and potentially first in class medication is currently under the priority review by the agency for the treatment of moderate-to-severe acute pain with a Prescription Drug User Fee Act target action date of January 30, 2025.3 If approved, suzetrigine would be the first new class of medications for treatment of acute pain in 20 years, according to Vertex.3
“Our goal in developing suzetrigine is to deliver the first non-opioid acute pain treatment in more than two decades and to change the paradigm of pain management as we know it,” Carmen Bozic, MD, executive vice president, global medicines development and medical affairs, at Vertex, said in the release.1 “We are very pleased to have these Phase 3 data selected for presentation in the 'Best Abstract' session at the annual ASA meeting and the opportunity to share these important results in this forum.”1
"Renewed Optimism"
Commenting on what he calls the “renewed optimism” for the future of pain management reflected by the suzetrigine research, Todd Bertoch, MD, an anesthesiologist and researcher and the lead presenter for the phase 3 data said, “Suzetrigine offers the potential to fill the critically important treatment gap between opioids and other currently available therapies that have either limited efficacy and/or poor tolerability.”1 Bertoch is also CEO of CenExel JBR Clinical Research in Salt Lake City, UT.
During the “Best Abstract” session Vertex presented data from 2 randomized controlled trials in its phase 3 program that evaluated efficacy of suzetrigine to treat moderate to severe pain following bunionectomy and abdominoplasty.4 Each trial met its primary endpoints, resulting in a statistically significant improvement of the time-weighted sum of the pain intensity difference from 0 to 48 hours compared to placebo as well as a clinically meaningful reduction in pain from baseline at 48 hours on the widely used Numeric Pain Rating Scale.4 On the other hand, neither trial met the key specified secondary endpoint -- superiority over pain relief obtained with use of hydrocodone/acetaminophen in the studies’ control groups.4
A second abstract presented at ASA provided data from the Vertex phase 3 single-arm safety and effectiveness study. In that trial, investigators evaluated treatment with suzetrigine for up to 2 weeks across a variety of surgical and nonsurgical pain conditions and reported a favorable safety profile with no serious adverse events.4 Further, 83.2% of study participants rated suzetrigene as good/very good/excellent at treating pain as measured by a Patient Global Assessment following treatment.4
"In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain. Too many people today are either undertreated, dealing with negative side effects of currently available therapies or foregoing pain medications altogether for fear of becoming dependent on opioids,” Scott Weiner, MD, MHP, associate professor of emergency medicine at Brigham and Women’s Hospital and acute pain steering committee chair at Vertex, said in the announcement of the NDA. “Prescribers and patients deserve new options."3
Suzetrigine is highly selective for NaV1.8 voltage gated sodium channel relative to other NaV channels. NaV1.8 is selectively expressed in peripheral nociceptors where it transmits action potential. Selective inhibition of NaV1.8 using small molecules has the potential to create a new class of pain signal inhibitors that provide effective pain relief and avoid the addictive potential of opioids, the most frequently used medications used to treat acute pain.1
Vertex is also evaluating suzetrigine as treatment for painful diabetic peripheral neuropathy and for lumbosacral radiculopathy. Positive topline results have been reported for both conditions.
