30°
Journavx received FDA approval, the agency announced on Thursday, Jan. 30. The drug developed by Boston-based Vertex Pharmaceuticals blocks sodium channels in the peripheral nervous system, preventing pain signals from reaching the brain.
The approval marks the first new class of pain medicine in more than two decades and offers a potential non-addictive alternative to opioids.
"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 Vertex CEO and president Dr. Reshma Kewalramani. "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, often caused by injury or surgery, is typically managed with pain relievers that may include opioids. Journavx is approved for all types of moderate-to-severe acute pain and does not show evidence of addictive potential, according to Vertex.
The FDA has prioritized the development of non-opioid alternatives, issuing guidelines and awarding grants to encourage safer pain treatments.
"Today's approval is an important public health milestone in acute pain management,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research. "A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option."
Journavx was evaluated in two clinical trials involving patients recovering from abdominoplasty and bunionectomy surgeries. In both studies, patients using the drug reported significantly greater pain relief compared to those given a placebo.
Participants were also allowed to take ibuprofen for breakthrough pain if needed.
"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 Dr. Jessica Oswald, a member of Vertex's acute pain steering committee. "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 drug's safety profile was evaluated in more than 1,100 patients, including those in a separate open-label study on various acute pain conditions. Common side effects included itching, muscle spasms, increased blood creatine phosphokinase levels, and rash.
The FDA warns that Journavx should not be taken with strong CYP3A inhibitors or grapefruit products due to potential drug interactions.
Vertex has also launched patient support programs to help eligible patients access the medication.
Click here to follow Daily Voice Harrison and receive free news updates.
