FDA approves Journavx, a nonopioid painkiller without addictive potential

Author(s):

Medical Economics Staff

Key Takeaways

Journavax, a nonopioid painkiller, blocks peripheral pain signals, offering a non-addictive alternative for moderate-to-severe pain management.
The FDA's approval of Journavax marks the first new pain treatment approach in over 20 years, providing a significant advancement in pain management.
Priced at $15.50 per 50mg pill, Journavax is approved for twice-daily use in adults with moderate-to-severe acute pain.
Vertex is conducting a late-stage trial of suzetrigine for peripheral neuropathic pain, including diabetic peripheral neuropathy.

Journavx, by Vertex Pharmaceuticals, is a well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain.

The FDA on Thursday approved Journavax, a first-in-class oral nonopioid painkiller without evidence of addictive potential, according to its maker, Vertex Pharmaceuticals.

It's the first new approach for treating moderate-to-severe pain in more than 20 years and works by blocking pain signals in the body's periphery, not in the brain, and thus can relieve pain without the addictive potential of opioids.

Read more at Patient Care Online

Our clinical news brand, Patient Care Online, has more on this groundbreaking approval:

Learn more about the clinical aspects of Journavx, including method of action and other details.

Watch an exclusive interview with Todd Bertoch, MD, lead investigator on key trials on the road to Journavx's approval.

“This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,” said Jessica Oswald, M.D., M.P.H., Associate Physician in Emergency Medicine and Pain Medicine in San Diego and Vertex Acute Pain Steering Committee Member, in a Vertex news release. “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.”

The FDA approval is for twice-daily use for the treatment of adults with moderate-to-severe acute pain. Vertex announced the U.S. list price for Journavx will be $15.50 per 50mg pill.

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.

Vertex is also evaluating the drug, known also by its scientific name suzetrigine, for treatment of peripheral neuropathic pain. The company has an ongoing late-stage trial for suzetrigine in patients with painful diabetic peripheral neuropathy.