FDA Approved Non Opioid Pain Medication
The US Food and Drug Administration (FDA) has approved a novel non-opioid analgesic that aims to relieve short-term pain in adults.
Journavx, a brand name for the drug suzetrigine, functions by intercepting pain signals prior to their arrival at the brain.
Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, have been approved by the U.S. Food and Drug Administration for the treatment of moderate to severe acute pain in adults. Prior to the transmission of pain signals to the brain, Journavx reduces pain by inhibiting a pain-signaling pathway that involves sodium channels in the peripheral nervous system.
Journavx is the inaugural medication in this novel category of pain management medications.
Pain is a prevalent medical condition, and its alleviation is a critical therapeutic objective. Acute pain is a type of short-term pain that is typically induced by a tissue injury, such as surgery or trauma. Analgesics that may or may not contain opioids are frequently employed to reduce acute pain.
The FDA has consistently advocated for the advancement of non-opioid pain treatment. The FDA has awarded cooperative grants to support the development and dissemination of clinical practice guidelines for the management of acute pain conditions and issued draft guidance as part of the FDA Overdose Prevention Framework to encourage the development of non-opioid analgesics for acute pain.
"The FDA's Center for Drug Evaluation and Research's acting director, Jacqueline Corrigan-Curay, J.D., M.D., has declared that approval is a significant public health milestone in acute pain management." "A novel non-opioid analgesic therapeutic class for acute pain presents an opportunity to reduce certain risks associated with the use of opioids for pain and offers patients an additional treatment strategy." The FDA's dedication to the approval of safe and effective alternatives to opioids for pain management is emphasized by this action and the agency's designations to expedite the drug's development and review.
In two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, the efficacy of Journavx was assessed following abdominoplasty and bunionectomy, respectively. In addition to receiving the randomized treatment, all participants in the trials with insufficient pain control were allowed to use ibuprofen as required for "rescue" pain medication. Journavx exhibited a statistically significant superior reduction in pain compared to the placebo in both trials.
The safety profile of Journavx is primarily derived from data from the pooled, double-blind, placebo- and active-controlled trials, which included 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy. Additionally, supportive safety data from a single-arm, open-label study of 256 participants with moderate to severe acute pain in a variety of acute pain conditions is included.
Itching, muscle spasms, an elevated blood creatine phosphokinase level, and a rash were the most frequently reported adverse reactions among study participants who received Journavx. Journavx is not recommended for use in conjunction with potent CYP3A inhibitors. Furthermore, patients should refrain from consuming grapefruit-containing foods or beverages while taking Journavx.
The FDA granted the application Breakthrough Therapy, Fast Track, and Priority Review designations.