Journavx Approval: Lead Investigator Highlights Pivotal Phase 3 Clinical Trials

“I've been the principal investigator for over 150 clinical trials, many of those in pain, and I've never seen a study where the placebo had more side effects than the study drug, and that was the case [here]."

The US Food and Drug Administration announced on January 30, 2025 the approval of Jouravx (suzetrigine), a first-in-class nonopioid analgesic for moderate-to-severe acute pain. The lead investigator of one of the key trials talked about suzetrigine and what it means in the pain treatment landscape.

"The real key here is that based on the evidence that we've seen, it appears we have a drug that's effective in treating pain but with an incredibly safe profile," Todd Bertoch, MD, continued in a recent interview with Patient Care.^© Bertoch, an anesthesiologist and CEO of CenExel JBR Clinical Research in Salt Lake City, UT, was a lead investigator on the phase 3 clinical trials that supported the January 30 FDA approval of suzetrigine, a novel highly selective voltage-gated sodium channel (Na_V1.8) inhibitor, for management of mild-to-moderate acute pain. It is suggested that selective inhibition of Na_V1.8 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. “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," Bertoch commented.

In the clinical trials Bertoch discusses in the short video above suzetrigine was compared with placebo to evaluate its efficacy in the management of moderate-to-severe pain following bunionectomy and abdominoplasty. He explains the method of assessment and his perspective on the findings, particularly in the area of safety.

Todd Bertoch, MD, is an anesthesiologist and CEO at JBR Clinical Research, CenExel in Salt Lake City, UT. Bertoch served as an anesthesiologist in the US Air Force where he gained extensive experience in both trauma medicine and pain management. As the managing partner of an anesthesia practice in Prescott, AZ, Bertoch's practice focused on pain management and addiction medicine. Since joining JBR clinical research, he has served as principal investigator for more than 150 clinical trials.