S.On January 30, the US Food and Drug Administration (FDA) consent A new drug called suzetrigine to treat moderate to severe pain. The described birth control pills, which are sold under the Journavx brand name, are taken by Vertex Pharmaceuticals, twice a day and represent the first new category of pain medications in 20 years-and the first non-audio residence since the first time of that category in the market in the eighties.
While opioids are currently the most effective and effective way to control pain, they are associated with a great danger to addiction, and the addiction epidemic and excessive mortality in the United States have been fed in recent decades. From 1999 to 2017, Deaths from an overdose Because of the opium recipe, it has increased more than seven times, which exposes an urgent need for effective but non -anti -pain management methods.
Here is what to know about suzetrigine.
How works suzetrigine
There is a major channel for the transmission of pain in the human body through sodium channels. People have nine sodium channels in the body, and different channels are active in different tissues, including in the brain.
Suzetrigine relieves pain by controlling the flow of sodium inside and outside the cells, and one sodium channel for neurons targets the pain in the tissues across the body but not in the brain. Consequently, the drug avoids addiction capabilities for Avionism, which works by linking with opioid receptors throughout the central nervous system, in both the brain and spinal cord.
However, finding the correct target of the sodium channel took decades of search, which was more difficult because the sodium channels by definition are working quickly – so it is difficult to measure its effects, and the effects of any vehicles designed to control them. Once researchers identified the specific sodium channel that was selectively active in the nerves of pain, which is called NAV 1.8, scientists were combed in Vertex through vehicle libraries to find an effective inhibitor to prevent the opening of the channel. “We have examined hundreds of thousands of vehicles looking for a needle in the straw pile that prevents 1.8,” says Paul Niggoli, Senior Vice President at Vertex. Animal studies were encouraging, and the company launched human studies completed in early 2024. Vertex submitted a request to obtain the approval of the Food and Drug Administration in July.
What studies have not found
Experiments included people with acute pain after two types of surgery-removal of bonon and stomach stomachs-representing two main types of pain injuries: to bone tissues and softness, respectively. The researchers tracked the self -reported pain measures for 48 hours, starting immediately after their anesthesia. People are randomly assigned to receive suzetrigine, or hydrocodone-asytaminophen (Aphondia), or fake to treat their pain.
Tue those who receive suzetrigine about a larger and faster decrease in pain compared to those who take the fake end pills; Among those who get abdominal glycem, the most 61 % of those who take suzetrigine is a decrease of at least 30 % in pain, which researchers consider meaningful, compared to 48 % of the fake end. Among those who get a tumor removal, 83 % of those who take suzetrigine achieved this threshold, compared to 68 % of those who get a placebo.
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People appointed to the hydroqument and ancitaminophen group have been better to control pain than those who take suzetrigine, but suzetrigine does not bear the risk of addiction. “We have seen patients who have reported a significant decrease in pain,” says Dr. Jessica Macon, a anesthesiologist who was one of the main investigators in experiments on both tumor removal and cosmetic abdominal in Senxel in Atlanta. One of the experimental sites. The results “Make me think Suzetrigine can replace the use of opiates, although I can definitely say that,” she says. “Any new category of drugs is a great opportunity, as we had nothing new in the pain space for 20 years.”
The company also conducted a third study of people with a wide range of cases associated with pain-surgical and non-surgical-affecting the head, neck, shoulder, knee, foot and ankle. In this study, patients knew that they were receiving the medicine. These results also showed that suzetrigine effectively reduced pain in a variety of cases.
Can you work for chronic pain?
Vertex also explores whether suzetrigine can manage chronic pain, which usually stems from a group of more complex and more sophisticated cases than acute pain. Those results It was less solid yet. Among the patients with sciatica, informed those who received suzetrigine and those who got an imaginary drug about similar small pain declines after 12 weeks.
However, Negulescu says that the company is moving forward with the later stage test to better control the effect of the imaginary drug and better understand the effect of the drug on chronic pain. “Our faith is that the Nav1.8 mechanism will be related to acute and chronic pain.”
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Negulescu says chronic pain can be tracked into two basic mechanisms. One affects muscles and bones – in arthritis and lower back pain, for example – which remains intact, but the surrounding tissues have been damaged and begin to send pain signals. Another type of chronic pain occurs when the same nerves are damaged, which occur in cases such as diabetes, especially in peripheral tissues such as fingers and foot. “We believe that the Suzetrigine mechanism is related to both muscle, organic and neuropathy,” says Negulescu. “Our work hypothesis, based on our data, is that Nav1.8 is still expressed in chronic conditions.”
How to agree to change the pain management
Equally from the activities of suzetrigine, it does not completely remove it. “Patients still feel pain. Negullescu says:“ They do not go to the feeling of pain. ”But he believes that suzetrigine indicates that it may be possible to improve in control of the sodium channel pain signal to achieve more pain management. He says:“ We enter A new era where we may be able to prevent pain in particular, especially in particular, and this will change our relationship and how we think about pain. “
Dr. Tod Birosh, chief medical official in Senxel Pain Research in Utah, who was the main investigator in Suzitrgen’s studies, notes that birth control pills were linked to relatively low side effects – a great discrimination of opioid materials. He says: “This is the first study I conducted at all, as the profile of the side effect of the people in the imaginary medicine was worse than the side appearance of people who take the drug.”
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When suzetrigine remains a suitable scene of pain management, but experts see its potential in treating more dangerous pain, if the unimaginable treatments do not succeed. Ideally, pain experts believe that it can be the first treatment after surgeries and simple procedures, including dental procedures, instead of the opioid materials currently described.
Beiroch says opioids may continue to get a place in treating certain types of pain, but suzetrigine gives doctors another option. “Suzetrigine allows me to add another tool that does not contain a toxic to the liver, and it has no toxicity in the kidneys, which is very safe, it is at least added, and perhaps synergy with acetaminophen and ibuprofen,” he says. “Fill a gap where we used aids.”