FDA Approves Suzetrigine, A New Class of Non-Opioid Analgesic

By Genni Burkhart, Incisor Editor

Approved by the U.S. Food and Drug Administration (FDA) on January 30, 2025, suzetrigine, marketed under the brand name Journavx, offers a groundbreaking non-opioid pain-relieving alternative. As the first acute pain management drug approved in over two decades¹, the 50 mg oral tablet treats moderate to severe pain in adults.

The FDA’s commitment to advancing non-opioid pain treatments played a key role in the development of suzetrigine. Through initiatives like the FDA Overdose Prevention Framework, the agency has provided guidance and funding to drive innovation in acute pain management.

With the FDA’s approval of suzetrigine, dental professionals have a promising new option for post-surgical pain management.

A Breakthrough for Dental Pain

Manufactured by Vertex Pharmaceuticals, suzetrigine does not carry the typical risks of dependence and addiction seen with opioid medications. Considering dentists prescribed 8,910,437 opioid prescriptions² in 2022, finding safer, more effective alternatives to opioids is encouraging.

As an alternative to opioids, suzetrigine offers several advantages:

• Nonaddictive potential: Suzetrigine is not expected to have the addictive properties found in opioids.
• Effective pain relief: Clinical trials demonstrated a significant pain reduction compared to the placebo³.
• Broad use: Shown effective for a variety of acute pain management, including post-surgical pain

Suzetrigine (Journavx) Vs. Procaine (Novocain)

Suzetrigine works by targeting the Nav1.8 sodium channel, which plays a key role in acute inflammatory pain, such as post-op pain and neuropathic pain caused by nerve damage or disease.

NaV1.8 is found in peripheral sensory neurons, including those in the dorsal root ganglia, where it plays a key role in pain signal transmission. By selectively blocking these channels, suzetrigine helps prevent pain signals from reaching the spinal cord and brain, offering targeted relief without affecting other sensory functions.⁴

Suzetrigine blocks the NaV1.8 sodium channel in sensory neurons, preventing pain signals from reaching the brain. Unlike Novocaine, which affects sodium channels more broadly, suzetrigine offers targeted pain relief without widespread nerve blockade.⁵

How Effective Is Suzetrigine Compared to OTC Analgesics?

A study published in the Journal of the American Dental Association (JADA) recently concluded that a combination of over-the-counter pain relievers, such as acetaminophen and ibuprofen, is more effective than opioids for pain management after dental surgery. But how does suzetrigine compare?

Because suzetrigine is not yet FDA-approved to treat chronic pain, we'll only consider suzetrigine for the treatment of moderate to severe acute pain in adults. Foremost, the FDA categorizes suzetrigine for moderate to severe acute pain, while acetaminophen and ibuprofen are approved for mild to moderate pain.

ADA Guidelines on Suzetrigine

The American Dental Association (ADA) has not provided official guidelines for suzetrigine in dental settings. However, given that suzetrigine was recently approved, the ADA likely has not had the opportunity to review and incorporate information about this new drug into its guidelines or create specific resources for dentists.

The ADA’s most recent pain management guidelines, published in 2023/2024, do not include information on suzetrigine, which the FDA only approved on January 30, 2025.

The ADA’s current guidelines and resources focus on:

• Recommending nonsteroidal anti-inflammatory drugs (NSAIDs) alone or in combination with acetaminophen as first-line treatments for managing short-term dental pain in adults and adolescents aged 12 or older.
• Providing guidance on opioid prescribing and alternatives to opioids for pain management.
• Offering resources on acute dental pain management, including dosing guides and chairside guides for various dental procedures

A Modern Approach to Pain Management

Suzetrigine represents a promising addition to post-surgical pain management, allowing dentists to combine it with non-opioid analgesics like NSAIDs or acetaminophen for more comprehensive relief. As pain can vary greatly depending on the patient and the procedure performed, the effectiveness and lower risk of side effects with suzetrigine stands to improve patient care. Furthermore, as a non-opioid pain management option, suzetrigine supports minimizing opioid prescriptions.

While this new medication holds potential, staying informed will be key to integrating it into safe clinical use.

References:

1. Giara K. Suzetrigine: Pending approval signals a shift in non-opioid pain management. MedCentral. Updated January 30, 2025. Accessed February 11, 2025.
2. Zhang J, Nalliah RP, Waljee JF, Brummett CM, Chua K-P (2023) Association between the COVID-19 outbreak and opioid prescribing by U.S. dentists. PLoS ONE 18(11): e0293621
3. American Journal of Managed Care. Suzetrigine: First-In-Class Non-opioid Pain Therapy is Approved by the FDA. Published January 30, 2025. Accessed February 10, 2025.
4. MedCentral. (2025, January 30). Suzetrigine’s Approval Signals a Shift in Non-Opioid Pain Management. Retrieved February 10, 2025, from MedCentral
5. Vertex Pharmaceuticals Incorporated. Suzetrigine (Journavx) prescribing information. Published January 2025. Accessed February 11, 2025.

Author: With over 15 years as a published journalist, editor, and writer, Genni Burkhart's career has spanned politics, healthcare, law, business finance, technology, and news. She resides in Northern Colorado, where she works as the editor-in-chief of the Incisor at DOCS Education.