FDA Accepts NDA for Suzetrigine to Treat Moderate, Severe Acute Pain

The FDA accepted a new drug application (NDA) for suzetrigine to treat moderate-to-severe acute pain, Vertex Pharmaceuticals announced in a news release.¹ The therapy, which was granted priority review with a Prescription Drug User Fee Act (PDUFA) date of January 30, 2025, would be the first new class of medicine to treat acute pain in over 20 years if approved.

FDA Accepts NDA for Suzetrigine to Treat Moderate, Severe Acute Pain / JHVEPhoto - stock.adobe.com

Suzetrigine, which was previously known as VX-548, is an investigational oral, selective NaV1.8 pain signal inhibitor. It is highly selective for the voltage-gated sodium channel NaV1.8, whose role is to transmit pain signals and is a genetically validated target for the treatment of pain. Suzetrigine was previously granted both FDA Fast Track and Breakthrough Therapy designations.

"In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain,” Scott Weiner, MD, MPH, Acute Pain Steering Committee Chair at Vertex, said in a release.¹ “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. Prescribers and patients deserve new options."

The FDA’s acceptance of the NDA for suzetrigine was supported by data from a phase 3 program that included 2 randomized, double-blind, placebo-controlled trials; 1 following abdominoplasty surgery and 1 following bunionectomy surgery. It also included a single arm safety and effectiveness study that included patients with a wide range of surgical and non-surgical pain conditions.

Data from the studies showed that suzetrigine met its primary endpoint of the time-weighted sum of the pain intensity difference from 0 to 48 hours, and a clinically meaningful reduction in pain from baseline at 48 hours on the Numeric Pain Rating Scale (NPRS) following both abdominoplasty and bunionectomy surgeries. When suzetrigine was compared to placebo, the mean difference in pain intensity from 0 to 48 hours for abdominoplasty was 48.4 and for bunionectomy it was 29.3, representing a statistically significant improvement.²

Of the patients in the single arm safety and effectiveness study, 83.2% rated suzetrigine as good, very good, or excellent in treating pain based on the Patient Global Assessment (PGA) scale.

In all 3 studies, suzetrigine was safe and well tolerated by patients, with the majority of adverse events being mild-to-moderate. Data from the 2 randomized controlled trials showed that following abdominoplasty, 50% of patients who received the therapy had adverse events, compared to 56.3% in the placebo group. Following bunionectomy, 31% of patients who received the therapy had adverse events, compared to 35.2% in the placebo group.

“[The] FDA filing acceptance for suzetrigine marks a critical milestone toward bringing this new, transformative non-opioid analgesic to the millions of patients suffering from moderate-to-severe acute pain each year in the US,” Nia Tatsis, PhD, executive vice president, and chief regulatory and quality officer at Vertex, said in a release.¹ “The FDA’s granting of a priority review further reinforces the high unmet need in treating acute pain, and the filing brings us one step closer to our objective of filling the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.”

READ MORE: Pain Management Resource Center

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References

1. Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain. News Release. Vertex. July 30, 2024. Accessed July 31, 2024. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-acceptance-new-drug-application-suzetrigine

2. Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain. News Release. Vertex. January 30, 2024. Accessed July 31, 2024. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-vx-548-phase-3-program