FDA Approves Journavx: A New Non-Opioid Pain Medication

In January 2025, the U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine), an oral, non-opioid pain medication developed by Vertex Pharmaceuticals, for the treatment of moderate to severe acute pain in adults. This approval marks the first introduction of a new class of pain medicine in over two decades.

Journavx functions by selectively inhibiting the NaV1.8 sodium channel, which is specific to pain neurons in the peripheral nervous system. By blocking these channels, the drug prevents pain signals from reaching the brain, thereby reducing the risk of addiction associated with traditional opioids.

Clinical trials demonstrated that Journavx significantly reduced pain compared to a placebo in patients undergoing surgeries such as abdominoplasties and bunionectomies. However, the drug was less effective in chronic pain conditions like sciatica.

Vertex Pharmaceuticals has priced Journavx at $15.50 per 50-milligram pill. This pricing strategy positions Journavx as a premium alternative to generic opioids, which are typically less expensive. The higher cost may influence insurance coverage decisions and patient accessibility.

Despite the initial approval, Vertex faced challenges in expanding Journavx's indications. In August 2025, the FDA did not support a broad label for peripheral neuropathy, leading Vertex to halt plans for a phase 3 trial in lumbosacral radiculopathy and instead focus on diabetic peripheral neuropathy.

Additionally, Vertex discontinued the development of VX-993, another non-opioid painkiller, after it failed to demonstrate significant efficacy over placebo in a mid-stage clinical trial.

The approval of Journavx offers a promising alternative for pain management, addressing the ongoing opioid crisis by providing effective pain relief without the associated risks of addiction. However, its higher cost compared to generic opioids may limit accessibility for some patients.

Vertex Pharmaceuticals is a biotechnology company specializing in the development of small-molecule drugs for serious diseases. The company has a strong presence in the cystic fibrosis market and is actively diversifying its portfolio to include non-opioid pain solutions.

"With the approval of JOURNAVX, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care," said Reshma Kewalramani, M.D., CEO and President of Vertex Pharmaceuticals.

"I believe JOURNAVX could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed," said Jessica Oswald, M.D., M.P.H., Associate Physician in Emergency Medicine and Pain Medicine.

As of October 9, 2025, Vertex Pharmaceuticals' stock (VRTX) is trading at $417.46, reflecting investor interest in the company's developments.

The introduction of Journavx represents a significant advancement in pain management, offering a non-opioid alternative for acute pain relief. However, considerations regarding its cost and efficacy in chronic pain conditions will influence its adoption and impact on the opioid crisis.