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Core Topics => Drugs => Opiates & Opioids => Topic started by: Chip on January 31, 2025, 10:08:02 AM
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Source: https://www.forbes.com/sites/antoniopequenoiv/2025/01/30/fda-approves-non-opioid-painkiller-with-no-addiction-risk/?utm_medium=browser_notifications&utm_source=pushly&utm_campaign=6208007
Jan 30, 2025, 07:55pm EST
The FDA approved Vertex Pharmaceuticals’ “Journavx” on Thursday, greenlighting the non-opioid painkiller for treating moderate to severe pain in what the FDA considered the start of a new class of non-addictive medicines
Key Facts
The FDA approved Journavx for adults with moderate to severe pain after expediting the drug’s development and review.
The painkiller, which has a lofty list price of $15.50 per pill, blocks pain signals before they reach the brainlike opioids that reduce pain by latching on to receptors to the brain and create the risk of addiction.
Acute pain that can be treated by Journavx has been often treated with analgesics that might contain opioids, according to the FDA.
What Are Side Effects Of Journavx?
Journavx’s commonly reported side effects include nausea, rash, itching, headache, constipation and muscle spasms.
What To Watch For
Vertex plans to conduct a late-stage study of Journavx that could potentially lead to the drug being approved for chronic pain, which the FDA defines as pain that “persists for more than three months or pain that lasts more than one month beyond the normal healing time.”
Big Number
$1 billion. That is how much Wall Street analysts have estimated the painkiller could produce in annual sales.
Key Background
Journavx’s approval marks a significant development in coming up with alternatives to opioids, which has been sought as opioid use has resulted in a wave of drug addictions and overdoses among the American public.
Deaths involving opioids totaled 80,816 in 2021, nearly 11,000 more than 2020, according to the Centers for Disease Control and Prevention.
In 2020, an estimated 2.7 million people above the age of 11 had an opioid use disorder in the past 12 months, according to the 2020 National Survey on Drug Use and Health.
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https://www.nature.com/articles/d41586-025-00274-1?utm_source=Live+Audience&utm_campaign=7f8f44a224-nature-briefing-daily-20250131&utm_medium=email&utm_term=0_b27a691814-7f8f44a224-498702756
The US Food and Drug Administration has approved the non-opioid painkiller suzetrigine for short-term pain management.
Suzetrigine is the first pain drug given a regulatory nod in more than 20 years that works through a brand-new mechanism, without the risks of addiction or sedation.
Unlike opioids, the drug doesn’t act in the brain, instead blocking certain sodium channels in pain-sensing cells in the peripheral nervous system.
When it comes to chronic pain — where the need for safer, non-opioid alternatives is most pressing — trials haven’t proven suzetrigine’s efficacy, nor were they long enough to rule out side effects from long-term use.