Latest news with #Suzetrigine
Yahoo
23-04-2025
- Business
- Yahoo
Tonix's Experimental Non-Opioid Analgesic Treatment for Fibromyalgia Could Start Bringing Relief Later This Year
CHATHAM, NJ / / March 31, 2025 / This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice. Pain management is getting an upgrade, and Wall Street seems to be taking notice. For decades the pain drug market has been dominated by opioids that cause adverse side effects like addiction and overdose. In the wake of the opioid crisis and the new limitations on prescribing them, scientists and companies are chasing novel approaches to acute and chronic pain. A new crop of drugs is coming to the market to address acute and potentially chronic pain without many of the side effects, and that has Wall Street and pain sufferers paying close attention. Vertex Sets the Stage One only has to look at Vertex Pharmaceuticals, the drug company pursuing acute pain with a first-in-class NaV1.8 pain signal inhibitor drug. In January Vertex won Food and Drug Administration approval for VX-548, Journavx® (suzetrigine) its non-opioid drug for acute pain Suzetrigine. The company now sports a market capitalization of $123 billion, based also on it's other products. The trials that won approval for Journavx were in post-surgical settings after bunionectomy or tummy-tuck. These are indications in which short courses of opiates are generally prescribed and are recognized as useful. Another company going after the pain market - albeit in a different area - with a non-opiate pain remedy for fibromyalgia is Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP). Fibromyalgia is a chronic pain condition, not an acute pain condition. Fibromyalgia arises because of abnormal pain signaling in the brain, unlike acute pain, which is caused by tissue and nerve damage. The fully integrated biopharmaceutical company is developing its first-in-class tertiary amine tricyclic drug that acts in the central nervous system. Their drug TNX-102 SL* (cyclobenzaprine HCl sublingual tablets), a non-opioid investigational drug targeting fibromyalgia, which affects millions of Americans, mostly women. This type of pain impacts a large portion of the body or can be specific to extremities like the feet or hands. Fibromyalgia inflicts pain over many parts of the body, which is called "widespread" or "multi-site" pain. In addition to living with the chronic widespread pain of fibromyalgia patients often complain of fatigue and sleep problems. Two other types of drugs are already approved to treat fibromyalgia, gabapentinoids like Pfizer's Lyrica® and SNRIs like Lilly's Cymbalta®. Despite the availability of these once-popular brands, many fibromyalgia patients are dissatisfied. Unlike acute pain, most experts agree that opioids should never be used to treat fibromyalgia. Most experts agree that opioids provide no meaningful benefit to fibromyalgia patients and only lead to addiction. Tonix Positioning to Lead Like Vertex in the acute pain market, Tonix is hard at work positioning itself to become a leader in treating the chronic pain of fibromyalgia with a non-addictive treatment that's in the final stages of seeking FDA approval. It makes sense Tonix is going after the fibromyalgia market. Because fibromyalgia patients are typically affected for years or decades, and TNX-102 SL is expected to be used daily at bedtime, the number of prescriptions for each patient is expected to be larger than for acute pain which is typically a two-week course. However, both markets are large. According to one estimate the chronic pain drug market, which includes fibromyalgia, is forecast to grow from $72.10 billion in 2024 to over $115.51 billion by 2031, and the acute pain drug market is forecast to reach $103.6 billion by 2035. Sleep disturbance can have a big impact on chronic pain, making it feel worse. Lack of sleep can also hyperexcite the central nervous system (CNS), lowering pain tolerance. TNX-102 SL is a sublingual formulation that is designed to be taken daily at bedtime and to target the disturbed sleep of fibromyalgia. TNX-102 SL is not believed to be a sedative or hypnotic like Ambien® or Lunesta®. These traditional sedatives fail to address the sleep problem of fibromyalgia. Ambien has been studied and it does not improve fibromyalgia symptoms. FDA Approval Could Come as Soon as August TNX 102-SL is currently being evaluated by the FDA and the company expects the FDA could issue a decision on marketing authorization on August 15, 2025. That means it could potentially be on the market in 2025, giving fibromyalgia sufferers a much-needed new option. As it stands, Tonix says 85% of fibromyalgia patients fail their first-line therapy and 79% are on multiple therapies to no avail. Fibromyalgia can occur by itself, but it can also occur in the context of other conditions. The National Academies of Science, Engineering and Medicine (NASEM) recognized in June of last year that fibromyalgia is a diagnosable condition in Long COVID. The National Institute of Health just recently recognized that targeting sleep quality is a promising approach to treating long COVID. Tonix has completed a pilot study in multi-site pain associated with Long COVID and got encouraging results, particularly on improving fatigue. The recommendation by the NASEM to diagnose fibromyalgia in appropriate Long COVID patients may expand Tonix's addressable market. After all, the number of long COVID sufferers, which according to the World Health Organization is about 6 in every 100 people who contract COVID, outnumbers those who are believed to suffer from fibromyalgia without Long COVID. New data from the Medical Expenditure Panel Survey support prior findings that around 7% of adults in the U.S. have long COVID, which amounts to 17.8 million adults. It's unknown how many of these people also have fibromyalgia. From fibromyalgia to Long COVID patients and Wall Street, many are looking with hope at a new class of drugs to address an unmet need: pain medication that is not addictive and still effective. Companies like Vertex on the acute pain side and Tonix targeting fibromyalgia on the chronic pain side, are aiming to be leaders in these burgeoning markets. With Tonix's treatment under FDA review, it could be only a matter of time before that can potentially become a reality. *TNX-102 SL is an investigational new medicine and has not been approved for any indication. Click here for more information on Tonix Pharmaceuticals: This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Featured photo by Keenan Constance on Unsplashed. Contact InformationJessica MorrisTonix SOURCE: Tonix Pharmaceuticals Holding View the original press release on ACCESS Newswire Sign in to access your portfolio
Yahoo
31-01-2025
- Health
- Yahoo
FDA approves opiate-alternative acute pain management drug, local experts share their thoughts
ROCHESTER, N.Y. (WROC) – On Wednesday, the U.S. Food and Drug Administration approved a new pain management drug which could change the way healthcare providers address pain management. Suzetrigine, also known as Journavx, is classified within a new category of pain management medication without the same addictive qualities seen in many of its opiate competitors. Primary Care Provider at Trillium Health Dr. Stuart MacKay explained how it works. 'Opioid pain medication acts on a receptor in the brain called the 'mu opioid receptor'. This receptor is involved in the way your body processes pain,' MacKay said. 'Journavx works through a different pathway upstream of that, working before the pain signal even reaches the brain.' Rather than combat said pain at the brain, it functions at the peripheral site of pain. Journavx's manufacturer Vertex Pharmaceuticals says this lessens the addictive potential. 'Taking opioids every day alters the neurochemistry of your brain, making it dependent on that drug. So the thought is, if providers start this medication where it doesn't have that same dependence potential, it could act as a safer medication overall for acute pain,' McKay said. During its trial studies, Journavx was primarily researched in those experiencing pain due to abdominoplasties and bunionectomies. Currently, there is limited information available on if it is effective for prolonged chronic pain. Dr. MacKay hopes for more research to be done because of this. 'I would love to see a non-opioid medication that we can use for people with chronic pain that's equally as effective as opioids,' MacKay said. Among its disclosures, Vertex Pharmaceuticals noted multiple side effects of the drug including itching, muscle spasms and rash. They add those with pre-existing liver problems may be more prone to experiencing these side effects. The full list of disclosures can be found on Vertex Pharmaceuticals' website. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
31-01-2025
- Health
- Yahoo
FDA approves new pain medicine as opioid alternative. What to know about Journavx
For the first time in two decades, the FDA has approved a new class of non-opioid pain medication, offering an alternative to addictive opioids for patients seeking pain relief. The drug, suzetrigine, received FDA approval on Thursday and will be available as a 50-milligram prescription tablet taken every 12 hours. The approval was announced in an FDA press release, and it will be sold under the brand name Journavx by Vertex Pharmaceuticals. This painkiller's approval reflects the FDA's commitment to expanding non-opioid pain treatment options. Suzetrigine is the first medication in its class to gain federal approval in over 20 years The approval of Journavx is particularly significant for Florida, where opioid addiction has become a major public health issue. With an effective alternative now available, it could have a profound impact on reducing opioid use and its associated risks in the state. Here is everything you need to know. Vertex Pharmaceuticals announced that Journavx will be priced at $15.50 per pill. The FDA-approved medication, available as a 50-milligram prescription tablet taken every 12 hours, offers a non-opioid alternative for pain management. While the company asserts that the cost is in line with other brand-name pain medications, some experts, as reported by USA TODAY, have raised concerns about its affordability for patients who may need long-term treatment. What to know about Journavx: FDA approves new pain medication as an alternative to opioids Acute pain, which is typically sudden and caused by surgery or injury, affects 80 million Americans and is generally easier to manage in the short term. Each year, many of these individuals seek a prescription to address their pain, according to Vertex. Journavx works by blocking pain signals in the nervous system before they reach the brain, helping to alleviate discomfort. According to the FDA, the most common side effects experienced by study participants after taking Journavx included muscle spasms, itching, and rashes. Suzetrigine belongs to a new class of non-opioid pain medications known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs), which work by modulating neurotransmitters to help manage pain without the addictive risks associated with opioids, according to the FDA. Suzetrigine is not considered addictive. Unlike opioids, which carry a high potential for misuse and dependency, suzetrigine works through a different mechanism and does not produce the same addictive effects. This makes it a safer alternative for patients seeking pain relief without the risk of addiction, as confirmed by the FDA. Opioids are a class of drugs, including prescription painkillers like oxycodone and morphine, as well as illegal substances like heroin. These drugs are highly addictive and a major cause of the drug overdose crisis in the U.S., with synthetic opioids like fentanyl contributing to the majority of recent overdose deaths, according to the National Institute on Drug Abuse. Florida has been at the center of the opioid crisis for years, with thousands of residents affected by addiction and overdose deaths. In 2021, the state reported nearly 8,000 drug overdose deaths, with opioids — especially fentanyl —being the leading cause, according to the Florida Department of Health. Florida has taken steps to combat the opioid crisis, including stricter prescription regulations and expanded access to naloxone, a life-saving overdose reversal drug, according to the Florida Department of Health. The approval of Journavx, a non-opioid pain medication, could provide a safer alternative for pain management. Diamond Walker is a journalist at The Palm Beach Post, part of the USA TODAY Florida Network. You can reach her at dkwalker@ Help support our journalism. Subscribe today This article originally appeared on Palm Beach Post: Journavx painkiller approved by FDA is without opioids
Yahoo
31-01-2025
- Business
- Yahoo
No Major Catalyst, Wells Fargo Downgraded Vertex
January 31, 2025 Wells Fargo analyst Mohit Bansal was not excited by the upcoming launches of Vertex Pharmaceutical (NASDAQ:VRTX)'s drugs, Alyftrek and Suzetrigine. So, the analyst downgraded Vertex from Overweight to Equal-Weight and lowering the target price to $460, which was reached today. Bansal saw no major catalyst could drive the stock up in the near future, he also mentioned that Vertex might need to add more pipelines to its drug portfolio to drive growth. Warning! GuruFocus has detected 5 Warning Signs with VRTX. According to the consensus that consist of 29 analysts, the target price for Vertex is ranged from $325.00 to $591.00 with the average of $495.25. GuruFocus estimates the value for Vertex is $434.37, suggesting a downside from current price of $460.64. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
31-01-2025
- Health
- Yahoo
FDA approves new pain medication as an alternative to opioids: What to know about Journavx
For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage certain kinds of pain. The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release. The medication will be sold under the brand name Journavx for $15.50 per pill, according to Vertex Pharmaceuticals, the company that developed the new drug. The FDA's sign-off on the medication comes as the agency says it is prioritizing supporting the development of non-opioid pain treatment. Suzetrigine is the first non-opioid analgesic – or medication to control pain – of its class to receive federal approval in more than 20 years. Vertex Pharmaceuticals claimed in a press release that the medication can be used for many types of moderate-to-severe acute pain and has shown no evidence that it is addictive, like opioids. 'Today's approval is an important public health milestone in acute pain management,' Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research, said in a statement. "This action and the agency's designations to expedite the drug's development and review underscore FDA's commitment to approving safe and effective alternatives to opioids for pain management.' FDA news: Trump administration pauses communication from CDC, other health agencies Journavx was evaluated in two random double-blind experiments with a total of 874 participants following surgical procedures in which information was withheld from participants that may have influenced their behavior or perceptions. One of the drug trials followed abdominoplasty surgeries – known colloquially as a "tummy tuck" – while the other followed bunionectomies, or an operation on toes. Both trials involved randomly administering placebos and the active drug, and all participants were able to use ibuprofen if the pain became too great. "Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo," the FDA said in its press release. Acute pain is something more than 80 million Americans fill prescriptions to treat each year, according to Vertex. As opposed to chronic pain, which can last well after an injury or illness has been treated, acute pain is more sudden – often caused by surgery or injury – and is easier to treat in the short term. Journavx was found to help reduce pain by blocking pain signals in the peripheral nervous system before pain signals reach the brain. Reshma Kewalramani, CEO and president of Vertex, called the drug's approval "a historic milestone" in a statement. "We have the opportunity to change the paradigm of acute pain management and establish a new standard of care,' Kewalramani most common reactions study participants experienced after receiving Journavx were itching, muscle spasms and rashes, according to the FDA. Eric Lagatta covers breaking and trending news for USA TODAY. Reach him at elagatta@ This article originally appeared on USA TODAY: FDA approves new non-opioid pain medication Journavx: What to know
