29 Oct Suzetrigine: First New Class of Acute Pain Medicine Data Presented at ASA 2024 Meeting
MedicalResearch.com Interview with a Vertex spokesperson.
MedicalResearch.com: What is the background for this study? What are the main findings?
- We presented Phase 3 data for our investigational, oral pain signal inhibitor, suzetrigine, at ANESTHESIOLOGY 2024, the American Society of Anesthesiologists’ annual meeting. The Phase 3 data were previously announced in January 2024, and this is the first time the findings were presented to the medical community. The data were featured in the “Best Abstracts” session at the meeting.
- Our Phase 3 acute pivotal program for suzetrigine included two randomized, double-blind, placebo-controlled, pivotal trials, one following abdominoplasty surgery and one following bunionectomy surgery, as well as a single arm safety and effectiveness study which enrolled patients with a broad range of surgical and non-surgical pain conditions. All three studies demonstrated compelling and consistent efficacy and safety across multiple acute pain conditions and settings.
- Together, the data demonstrate suzetrigine’s potential to offer a safe, well tolerated and effective alternative to the current acute pain treatment paradigm, without addictive potential.
MedicalResearch.com: What should readers take away from your report?
- If approved by the FDA, suzetrigine could represent the first new class of acute pain medicines in >20 years, with potential to transform the treatment of pain.
- Suzetrigine is a highly selective pain signal inhibitor of NaV1.8, a voltage-gated sodium channel. NaV1.8 plays a key role in transmission of pain signals in the peripheral nervous system but is not expressed in the human brain. Suzetrigine is not expected to interact with the brain’s rewards pathway because its main target, NaV1.8, is not expressed in the brain, and has shown no evidence of addictive potential based on all available data.
- In acute pain, we believe that suzetrigine has the potential to fill the gap between medicines with manageable safety and tolerability but limited efficacy, and opioids with strong efficacy but substantial safety and tolerability concerns, including addictive potential.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
- The FDA has granted Priority Review to our NDA submission for suzetrigine for moderate-to-severe acute pain with a PDUFA target action date of January 30, 2025.
- In addition to our ongoing pivotal program in acute pain, we are also studying suzetrigine in peripheral neuropathic pain, or PNP, another significant area of unmet need for patients suffering from pain.
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- We recently initiated a Phase 3 pivotal program of suzetrigine in patients with painful diabetic peripheral neuropathy (DPN) and completed enrollment in our Phase 2 study of suzetrigine in painful lumbosacral radiculopathy (LSR) — both are PNP conditions.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: With ~80 million people being prescribed medicines for acute pain in the U.S. each year, the anticipated market size for suzetrigine is vast and diverse. We look forward to delivering on our commitment to providing alternative, non-opioid treatment options for patients, beginning with the anticipated launch of suzetrigine in moderate-to-severe acute pain.
Citation:
American Society of Anesthesiologists abstract presentations 2024:
- Randomized, Placebo-Controlled, Phase 3 Trials of Suzetrigine, a Non-Opioid, Pain Signal Inhibitor for Treatment of Acute Pain After Abdominoplasty or Bunionectomy”
- Oral presentation on Sunday, October 20 during the “Best Abstract” session (8-11 a.m. EDT)
- Phase 3, Single-Arm Study of Suzetrigine, a Non-Opioid, Pain Signal Inhibitor For Treatment of Acute Pain From Surgical and Non-surgical Conditions
- Poster session on Saturday, October 19 (10:00-11:30 a.m. EDT)
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Last Updated on October 29, 2024 by Marie Benz MD FAAD