Vertex gets FDA Okay for Non-Opioid Painkiller

 Vertex Pharmaceuticals has announced that the FDA has approved Journavx (suzetrigine) for the treatment of adults with moderate-to-severe acute pain, like the kind that follows surgery, accident or injury. Journavx is an effective, well-tolerated medicine without evidence of addictive potential.

“Today’s approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” said Reshma Kewalramani, CEO and President of Vertex. “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.”

Acute pain is a serious and potentially disabling condition often caused by surgery, accident or injury. Over 80 million Americans are prescribed medicine to treat their moderate-to-severe acute pain every year. Of these, about 40 million are prescribed an opioid. Nearly 10% of acute pain patients treated initially with an opioid will go on to have prolonged opioid use, and about 85,000 patients will develop opioid use disorder annually. Poorly controlled acute pain can lead to reduced quality of life, development of chronic pain, and increased burden on the health care system and society.

Because Journavx blocks pain signals only found in the periphery, not in the brain, it provides effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.

Vertex is also evaluating suzetrigine in peripheral neuropathic pain (PNP). The company’s Phase 3 pivotal program for suzetrigine in patients with painful diabetic peripheral neuropathy is ongoing, and Vertex plans to advance its pivotal program evaluating suzetrigine in patients with painful lumbosacral radiculopathy pending discussions with regulators. (Source: Vertex Website, 30 January, 2025)