NBC News
The Food and Medicines Administration (FDA) approved on Thursday a new type of non -opiatic analgesic of VERTEX Pharmaceuticals.
The drug, Journavx or Suzetrigine, has been approved to treat acute, or short -lived pain, moderate to intense in adults. The experts affirm that the drug, which is announced as non -addictive, could reduce the number of opiates that are prescribed to patients after surgical intervention or be used by patients who cannot take other analgesics, although several told NBC News that They would like to see more research in this regard.
Dr. Jacqueline Corrigan-Curay, acting director of the FDA Medication Evaluation and Research Center, described the approval in a statement as an “important milestone for public health in the treatment of acute pain”.
For his part, Michael Schatman, clinical instructor of the Department of Anesthesiology, Perioperative Care and Pain Medicine of the Grossman Faculty of Medicine of the University of New York, said: “I think that in acute pain this drug is very promising. I could save opiates, and we need more tools for pain. ”
Although in recent years the number of patients returning home with opiates has decreased after surgical intervention, many continue to leave the hospital with recipes. Despite the risks, opioids are extremely effective in treating pain, which has left doctors and patients with few options when paracetamol (Tylenol) and non -steroidal anti -inflammatories, such as ibuprofen, are not enough.
“We know for the CDC data that any person exposed to opiates can depend on them,” says Dr. Richard Rosenquist, company director of the Pain Treatment Department of the Neurological Institute of the Cleveland Clinic.
The body records pain through the nerve endings of the whole body. Touching a hot stove, for example, causes the nerve to send signals to the spinal cord and even the brain that pain is being experienced in the hand.
Opioids stimulate opioid receptors of the brain and block those pain signs. During the process, the brain is also flooded with the neurotransmitter dopamine, which creates euphoria sensations and activates the brain reward system. That is why opiates can be incredibly addictive.
The Vertex drug acts in a completely different way: first, it prevents the pain signal from reaching the brain. The signal is triggered by sodium molecules that rush into the nerve termination and send the message to the brain.
Suzetrigine is a blocker of sodium channels, the same type of drug as lidocaine. Lidocaine, a local anesthetic, acts by blocking all sodium channels in the area in which it is applied; For example, gums during dental treatment. A blocker of sodium channels taken in the form of a pill, such as suzetrigine, must be much more precise, since sodium channels are found throughout the body and are fundamental for the functioning of the heart and the brain. Suzetrigine prevents the nerve impulses of a single sodium channel, NAV1.8, to reach the brain and be interpreted as pain.
“It is the first time we have something aimed at a specific sodium channel,” says Rosenquist, who did not participate in the drug investigation.
The process either stimulates opioid receptors or produces any feeling of euphoria.
“Right now, all indications suggest that it has no addiction potential,” says Rosenquist. “It is not different from Tylenol or ibuprofen in terms of addiction potential.”
Abdominoplasty and Junets Surgery
In phase 3 clinical trials carried out by the drug manufacturer, the researchers analyzed the efficacy of the medication after surgical intervention. Suzetrigine was administered every 12 hours to patients who had undergone abdominoplasties or youth surgery; an opioid, hydrocodone, more tylenol every six hours; or a placebo for 48 hours after operations.
Some of the patients who received Suzetrigine also took ibuprofen as a rescue medication, that is, if they continued to feel pain after the suzectrigine dose.
“The results we have now not tell us much about the amount of rescue medication that was used,” said Dr. David Rind, Medical Chief of the Institute for Clinical and Economic Review (ICER), a non -profit group that evaluates the cost, safety and efficacy of drugs. “We do not know if they would have had a greater reduction in pain if they had limited themselves to taking a NSAIDs from the beginning.”
Both patients undergoing abdomen cosmetic surgery and those operated by bunions received by Suzetrigin reported a pain reduction of around 50% after 48 hours, similar to the reduction of pain communicated by patients who received the opioid more Tylenol .
About 50% of the people in the abdomen cosmetic surgery group and around 30% of the juane surgery group reported some type of side effect, more frequently headache, constipation or nausea, but, except in the case Of constipation, the side effects were less frequent in patients who received suzetrigin compared to an opioid.
In addition, the hydrocodone dose was lower than the one that is usually administered after surgical intervention, “so it is difficult to know exactly what to think about the results,” said Rind.
In another phase 3 study, patients taking suzectrigin for surgery or acute pain valued their effectiveness. The participants took it every 12 hours for 14 days or until the pain sent. In that study, 82% of surgical patients and 91% of non -surgical said that suzectrigine was good, very good or excellent to treat their pain. About 37% experienced some type of adverse effect, but most were mild, such as headache, constipation, nausea, falls or skin rashes.
Dr. Todd Bertoch, Medical Director of Research on Pain at Cenexel JBr Clinical Research of Salt Lake City, directed the phase 3 tests of Suzetrigin in people who had undergone abdomen or juane cosmetic surgery.
Although the clinical trial showed that the drug could be effective as a single pain for pain – although it was more effective when patients combined it with ibuprofen -, the suzetrigine is designed to be used as part of a gradual approach, after Tylenol and NSAine, Bertoch explained.
“If I still have pain after that, I am a little stuck. My next step is an opioid, ”he said. “The goal is that the next step is not an opioid, and that is what suzectrigine does.”
Suzetrigin could also be used in patients for which Tylenol or NSAIDs are not safe, such as those suffering from kidney or hepatic diseases, he added.
There are still doubts, but doctors are promising.
In a report prepared last month by the ICER, a group of experts described the current data on suzetrigin as “promising, not conclusive.” According to the definition of the group, this means that there is a moderate certainty that the drug would provide a small or substantial benefit to patients and a small probability – but not null – of negative health consequences.
According to RIND, the potential risk of tolerable damage depends on the type of drug in question. For example, it is widely accepted that cancer medications have serious side effects, but not enough to compensate for the potential benefit of the treatment of often mortal disease.
In those situations, “you are willing to accept a higher risk,” said Rind. “In the case of a new analgesic, it has to be incredibly safe to be well, and we will not know until many people are in the market and use it.”
The new drugs such as suzetrigin should first be tested in people who cannot take other analgesics, he added. For example, someone with a history of gastrointestinal hemorrhage, who makes NSAIDs dangerous, and addiction, who would deter a doctor from prescribing opiates, would be a good candidate for Suzetrigin.
“There are many people like that. It is not a tiny segment of the population, ”said Rind.
Despite the doubts that still persist about the effectiveness and long -term safety of the drug, Rind said that the doctors he has spoken are excited about the medication.
“Virtually all pain experts we have talked to have told us how enthusiasm that they are about .
Schatman, from the Grossman Faculty of Medicine of the University of New York, said that suzetrigine seems safe and effective in the short term; However, he expressed concern about the fact that VERTEX does not have long -term security data. Schatman is the main medical advisor of Apurano Pharma, a German biotechnological company, and is working on a similar drug for chronic pain.
“There are relatively solid security data for short -term use, and that is what the FDA demands,” he said, but there is no fixed definition of the duration of acute pain. VERTEX does not intend that the FDA approves the suzetrigine to treat chronic pain – a phase 2 clinical trial on the suzectrigin for sciatica concluded that it did not reduce the pain better than a placebo after 12 weeks – but it is common for doctors They prescribe analgesics for acute pain for chronic pain. In his opinion, this is worrying.
“What worries me most is that there are drugs that demonstrate their effectiveness for acute pain and, suddenly, extrapolate the data to chronic pain,” he added.
Since suzetrigine blocks pain signals in the peripheral nervous system – the nerves that carry the signals to the central nervous system -, most likely, the drug does not work for chronic pain, which is usually based on the central nervous system, Dr. Holly Geyer, Mayo Internist from the Rochester Clinic (Minnesota) pointed out.
Rosenquist said that, although new studies show that suzectrigin does not block acute pain better than opiates, he believes that it is likely to continue to have a place in the treatment of pain.
“You have this tool that you can give to people in cases where they are discharged, they are in that recovery process, we ask them to make rehabilitation or walks or things like that, and they would have gone home with an opioid,” said. “The gradual approach is a reasonable way of addressing it. It could contribute to reducing general exposure to opiates. ”
According to Schatman and Rosenquist, most likely the fact that doctors resort to this drug depends on their cost. Rind, from Icer, commented that it is likely that it depends both on how to see prices of the new medicine and in what contexts, where appropriate, private insurers cover it.
“In short, NSAIDs, generic opiates and paracetamol are cheap,” said Schatman, who added that he hopes that the price of suzetrigine allows patients to access it.