Suzetrigine is a new non-addictive painkiller that's as strong as Vicodin

But access will be a major obstacle without a policy intervention.

Over 107,000 Americans died from overdoses last year and a large portion of those deaths were people who became addicted to opioids through a medical prescription (1, 2). Suzetrigine has the potential to dramatically reduce the number of opioids prescribed in our medical system while still offering substantial pain relief to patients. The opportunity for public health is massive.

Suzetrigine (VX-548) is a novel non-opioid, sodium channel painkiller with no addictive potential, from Vertex. It has shown positive results in Phase 3 and is now being submitted to the FDA for approval, possibly by the end of 2024. 

Unfortunately, suzetrigine will come to market on-patent and insurance companies will not cover it unless patients try opioids first. Here’s our proposal to make suzetrigine affordable for everyone.

Getting Suzetrigine Approved

In their current FDA application, Vertex is seeking “a broad label” for moderate to severe acute pain. Vertex also hopes to get an indication for peripheral neuropathic pain, which is a form of chronic nerve pain:

“In support of this goal, the company recently reported positive Phase 2 results in painful diabetic peripheral neuropathy (DPN) and expects to advance to pivotal development in DPN with VX-548 following the end-of-phase 2 meeting with the FDA. Vertex has also initiated a Phase 2 peripheral neuropathic pain study of VX-548 in patients with painful lumbosacral radiculopathy, or LSR, which is pain caused by impairment or injury to nerve roots in the area of the lumbar spine.”

Vertex is also running a phase 2 study on patients with lumbosacral radiculopathy (LSR) which is pain caused by lumbar nerve damage.

Suzetrigine Efficacy in Acute Pain

Suzetrigine appears to outperform HB/APAP (hydrocodone bitartrate / acetaminophen aka Vicodin) for pain from abdominoplasty but not for bunionectomy, which are used as representative cases for acute pain:

As you can see in the results above from the trial published in NEJM, suzetrigine was superior at times, inferior at times, but overall roughly comparable to hydrocodone+acetaminophen (HB/APAP). This means it will be a great option to have patients try first in many situations. What’s crucial for now is that we stop using opioids as the default in so many perioperative situations.

There is no reason to believe that suzetrigine would be contraindicated for combination with acetaminophen so it is possible that suzetrigine+acetaminophen may outperform HB/APAP for patients.  It’s unfortunate that this comparison was not trialed. 

An Opportunity to Dramatically Reduce Opioids in Medicine

Studies find that roughly 80-90% of people who have opioid use disorders (OUD) started with prescription opioids (1, 2). Some providers believe that the percentage of people who develop an opioid use disorder because of prescription opioid exposure has fallen in recent years, but it is still clearly a major driver of new addiction.

With new options like suzetrigine and the right policies, we can dramatically reduce the use of opioids in medicine and dentistry, while providing patients with effective pain management.

At a deeper level, there is evidence that opioids are not very effective for long term pain and that we may be able to prescribe them much less often, even without a novel non-addictive alternative.

For example, American dentistry prescribes a massive amount of opioids compared to other countries:

“In 2016, the proportion of prescriptions written by US dentists that were for opioids was 37 times greater than the proportion written by English dentists. In all, 22.3% of US dental prescriptions were opioids (11.4 million prescriptions) compared with 0.6% of English dental prescriptions (28,082 prescriptions).” JAMA 2019

Even without a strong painkiller option like suzetrigine, prescribing less opioids after medical or dental procedures seems like an obvious win and there has been progress in that direction. Modalities like acupuncture, massage, spinal manipulation, physical therapy, heat/cold application, and psychological therapies have also shown efficacy. 

The current crackdown on overprescribing of opioids  has substantially reduced the number of prescriptions written each year by about 50% and that includes dentists. Unfortunately, the crackdown also led to a number of negative effects, including chronic pain patients being denied sufficient pain medicine or being suddenly cutoff from opioids and forced into withdrawal. This lead to a huge number of people with OUD transitioning to black-market fentanyl when prescription pills became harder to get. This paper provides a good overview.

Suzetrigine could mark the beginning of a new era for pain treatment, where giving patients effective medication does not risk generating addictions.

But there’s a huge problem looming: suzetrigine will come to market as an on-patent drug with a high price and payers (insurance companies, Medicaid, and Medicare) will not pay for it unless a patient has tried opioid painkillers first. That means we will be creating more opioid addictions in patients.

Next Steps for Suzetrigine

Over the next few months, our organization, CASPR, will be advocating privately and publicly with legislators, policymakers, and other organizations to try to ensure that opioid-replacing painkillers are available as first-line treatments, which can benefit both the public and the companies developing non-addictive pain medication. Fixing this market failure could save tens of thousands of lives and make a significant dent in the scale of the opioid crisis.

Our next article will dive into this problem and a possible solution. We hope you will subscribe below (it’s totally free) and if you can help us advance this effort, please be in touch.