Today, the Food and Drug Administration of the United States has approved Jouravx (Suzetrigine) 50 milligrams of oral tablets, a first-row non-opioid pain reliever, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain in pain involving sodium channels in the peripheral nervous system, before pain signals reach the brain.

Journavx is the first medication to be approved in this new class of pain management drugs.

Pain is a common medical problem and pain relief is an important therapeutic objective. Acute pain is short -term pain which is generally in response to a certain form of tissue lesion, such as trauma or surgery. Acute pain is often treated with pain relievers that may or not contain opioids.

The FDA has long supported the development of non -opioid pain treatment. As part of the FDA overdose prevention framework, the agency has published a project of guidelines to encourage the development of non -opioid pain relievers for acute pain and has granted cooperative subsidies to support development and dissemination Clinical practice guidelines for managing acute pain conditions.

“Today’s approval is an important stage in public health in acute pain management,” said Jacqueline Corrigan-Curay, JD, MD, interim director of the Center for Drug Evaluation and Research of the FDA. “A new non -opioid analgesic therapeutic class for acute pain offers the possibility of mitigating certain risks associated with the use of an opioid for pain and provides patients with another treatment option. This action and the appointment of the agency to accelerate the development and examination of the drug underline the commitment of the FDA to approve of safe and effective alternatives to opioids for pain management. »»

The effectiveness of Journavx was evaluated in two randomized, double blind, placebo and active trials of acute surgical pain, one following abdominoplasty and the other after an onionctomy. In addition to receiving randomized treatment, all participants in trials with inadequate pain control were allowed to use ibuprofen if necessary for “rescue” pain medications. The two trials have shown a statistically significant superior reduction in pain with Journavx compared to placebo.

The Safety Profile of Journavx is Primary Based on Data from the Pooled, Double-Blind, Placebo- and Active-Controlled Trials in 874 Participants with moderate to Severe Acute Pain Following Abdominoplasty and Bunionecy, with supportive safety data from one single-arm, open – Study of the development in 256 participants with moderate to severe acute pain in a range of acute pain conditions.

The most common side effects in study participants who received daily were itching, muscle spasms, an increase in the blood rate of phosphokinase and a rash. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. In addition, patients should avoid food or drinks containing grapefruit when taking daily.

The application received revolutionary therapy, a fast way and priority review by the FDA.

The FDA has granted the DaiLenavx approval to Vertex Pharmaceuticals Incorporated.

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