Shares of Vertex Pharmaceuticals gained over 7%, moving from $438 on January 30 to $470 after the company announced the FDA approval of its first-in-class, non-addictive, non-opioid oral pain drug, JOURNAVXTM (suzetrigine), for adults with moderate to severe acute (short-term) pain.

JOURNAVX is a highly selective NaV1.8 pain signal inhibitor that targets the voltage-gated sodium channel NaV1.8, relative to other NaV channels. NaV1.8 is expressed in peripheral pain sensing neurons (nociceptors), transmitting pain signals from the periphery to the brain. JOURNAVX functions by intercepting and inhibiting peripheral pain signals before they can reach the brain.

In addition to opening up a third market stronghold for Vertex, beyond cystic fibrosis and sickle cell disease/beta-thalassemia, we consider the approval a significant public health milestone, as JOURNAVX represents the first new class of pain medicine approved in more than 20 years, creating an opportunity for Vertex to establish a new standard of care in pain management.

The medicine also addresses a previously unmet market need for a non-opioid treatment that delivers effective acute pain relief without addictive potential. 80 million Americans are prescribed a medicine for moderate to severe acute pain every year, which typically results from tissue injury following surgery, accidents or injuries. About half (40 million) of these prescriptions are for opioids, and nearly 10% (4million) of acute pain patients initially treated with an opioid will continue to use opioids for extended periods of time. About 85,000 of these patients will develop opioid use disorder on an annual basis.

JOURNAVX will be sold in the U.S. at a wholesale acquisition cost of $15.50 per 50mg pill. Approved for twice-daily use, the medicine represents a significant economic opportunity for Vertex with blockbuster peak-sales potential.

In clinical trials, JOURNAVX proved safe and effective, without evidence of addictive potential. The drug’s efficacy was tested in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, both of which showed a statistically significant reduction in pain with JOURNAVX compared to placebo. While JOURNAVX delivered pain control similar to a weak opioid, it did not outperform it.

The most common adverse events in clinical trial participants receiving JOURNAVX were itching, muscle spasms, increased blood levels of creatine phosphokinase, and skin rashes.

Suzetrigine is also being evaluated in a Phase 3 pivotal trial for patients with chronic peripheralneuropathic pain (PNP) and a Phase 2 trial for patients with painful lumbosacral radiculopathy (sciatica).