FDA Approves Opioid-free Pain Medication That Finally Delivers Relief Without Addiction
Introducing the first new class of pain medicine approved by the U.S. Food and Drug Administration in more than two decades.
The FDA has approved the first drug in its class that targets moderate to severe acute pain in adults, without being addictive like opioids, which have been the standard of care in pain-killers for 20 years.
Boston-based Vertex Pharmaceuticals is set to sell the twice daily pills for $15 per dose under the name Journavx.
The analgesic works by “targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system—before pain signals reach the brain.”
“Today’s approval is an important public health milestone in acute pain management,” said FDA spokesperson Jacqueline Corrigan-Curay, J.D., M.D. “It provides patients with another treatment option.”
The efficacy of Journavx (aka suzetrigine) was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, both of which demonstrated a statistically-significant superior reduction in pain, compared to placebo.
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The safety was primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 participants going through surgery, with additional data from one single-arm, open-label study of 256 participants.
The most common adverse reactions in patients were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx. But, always check with your own doctor before taking the medication.
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“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,” Reshma Kewalramani, M.D., the CEO and President of Vertex said on January 30.
“With the approval of JOURNAVX, a non-opioid, pain signal inhibitor, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”
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