FDA approves non-opioid pain medication as new alternative for pain relief
Listen to article
The US Food and Drug Administration (FDA) has approved a new pain medication, suzetrigine, marking the first new type of pain reliever to be approved in over 20 years.
The drug, sold under the brand name Journavx, is a 50-milligram prescription pill taken every 12 hours after an initial larger dose.
This approval introduces a non-opioid analgesic option, offering a potential alternative to opioids, which are often associated with addiction and dependence.
Dr. Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research, emphasized the importance of suzetrigine as a new pain management option.
Suzetrigine works by blocking pain-signaling nerves around the body, preventing them from sending pain signals to the brain, unlike opioids, which affect the brain's perception of pain. This method aims to eliminate the risks linked to opioid use, such as euphoria and addiction.
The development of suzetrigine was inspired by a family in Pakistan with a rare genetic mutation that prevents pain signals from firing, allowing them to walk on hot coals without pain.
Researchers focused on the molecular mechanisms behind this phenomenon, leading to the creation of suzetrigine.
The drug works by blocking a specific sodium channel responsible for conducting pain signals.
In clinical trials, suzetrigine demonstrated effectiveness in managing pain after abdominal and foot surgeries, reducing pain by an average of 3.5 points on a scale of 0 to 10. However, its efficacy in treating chronic pain, such as sciatica, remains uncertain, as studies showed limited results compared to placebos.
Despite this, Vertex Pharmaceuticals, the drug's developer, continues to explore its use for chronic pain conditions like diabetic neuropathy.
Suzetrigine is now available at a wholesale cost of $15.50 per pill, with patient assistance programs to aid accessibility.
The approval of suzetrigine is seen as a significant step forward in pain management, providing both physicians and patients with a new, potentially safer alternative to opioids.
However, its success in the market will depend on insurance coverage and patient access.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Express Tribune
02-06-2025
- Express Tribune
Sanofi's $9.5B acquisition of Blueprint Medicines strengthens rare immunology portfolio
In a major move underscoring its ambition to lead in rare diseases and immunology, French pharmaceutical giant Sanofi announced its plan to acquire US-based Blueprint Medicines for up to $9.5 billion. The deal was announced by a press release on Sanofi's website. It is the largest by a European healthcare company this year and will see Sanofi paying $129 per share in cash, a significant premium that sent Blueprint's stock soaring in premarket trading. Blueprint Medicines, known for its specialty in treating systemic mastocytosis a rare blood disorder marked by the overproduction of mast cells brings to Sanofi a strong foothold in a niche yet critical area of medicine. The acquisition adds the FDA-approved drug Ayvakit, the only treatment for advanced systemic mastocytosis, to Sanofi's growing immunology portfolio. Sanofi CEO Paul Hudson framed the deal as a strategic leap forward, enhancing the company's pipeline and reinforcing its transformation into a global leader in immunology. We announced an agreement to acquire Blueprint Medicines, a biopharmaceutical company specializing in systemic mastocytosis, a rare immunological disease, and other KIT-driven diseases. — Sanofi (@sanofi) June 2, 2025 With a promising pipeline including next-generation therapies like elenestinib and BLU-808, the acquisition fits into Sanofi's broader ambition of innovation despite recent setbacks, including a failed lung disease drug trial. Industry analysts from JP Morgan praised the acquisition for its strategic and financial merits, forecasting Ayvakit could generate $2 billion in annual sales by 2030. Sanofi's ongoing spree of acquisitions, including Vigil Neuroscience and Inhibrx, signals a company doubling down on R&D investments to reshape its future. The acquisition aligns with Sanofi's broader strategy to invest heavily in US manufacturing and research, tapping into incentives and momentum driven by recent government policies. With Blueprint Medicines now joining its portfolio, Sanofi cements its stake in cutting-edge immunology treatments and rare disease therapies, positioning itself for long-term growth in a competitive pharmaceutical landscape.
Business Recorder
31-05-2025
- Business Recorder
US FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
The U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention, Moderna said in a statement. The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season. 'The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,' CEO Stephane Bancel said in the statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines. The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule. The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots. FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots. Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine. The approval for mNEXSPIKE was based on late-stage trial data, which showed the shot was not inferior in efficacy compared to Spikevax in individuals aged 12 years and older. The shot also showed superior efficacy compared to Spikevax in adults 18 years of age and older in the study. Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump's goal of dramatically shrinking the federal government. This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines. The CDC's outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign. The FDA approved Novavax's COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness. Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC. While Moderna's shots, as well as Pfizer-BioNTech's Comirnaty, are mRNA-based, Novavax's vaccine is protein-based and takes longer to manufacture. Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.
Express Tribune
28-05-2025
- Express Tribune
RFK Jr. halts routine COVID-19 vaccines for pregnant women, children
Vials labelled "VACCINE Coronavirus COVID-19" and a syringe are seen in front of a displayed U.S. flag in this illustration taken December 11, 2021. PHOTO:REUTERS Listen to article The US has stopped recommending routine COVID-19 vaccinations for pregnant women and healthy children, Health Secretary Robert F. Kennedy Jr announced in a social media post on Tuesday, circumventing the CDC's traditional recommendation process. Kennedy, FDA commissioner Marty Makary and National Institutes of Health director Jay Bhattacharya said in a video that the shots have been removed from the Centres for Disease Control and Prevention's recommended immunization schedule. The changes come a week after they unveiled tighter requirements for COVID shots, effectively limiting them to older adults and those at risk of developing severe illness. ‼️🇺🇸 BREAKING: Robert Kennedy Jr announces C0V1D VACC1NE for healthy CHILDREN and healthy PREGNANT WOMEN has been REMOVED from the CDC web page recommended IMMUNIZATION SCHEDULE. 😎 This is a BIG WIN for our children! 🇺🇸 — Diligent Denizen 🇺🇸 (@DiligentDenizen) May 27, 2025 Traditionally, the CDC's Advisory Committee for Immunization Practices would meet and vote on changes to the immunization schedule or recommendations on who should get vaccines before the director of the CDC made a final call. READ: Asia sees fresh spike in Covid-19 cases The committee has not voted on these changes. Kennedy, a long-time vaccine skeptic whose department oversees the CDC, has been remaking the US health system to align with President Donald Trump's goal of dramatically shrinking the federal government. Turned upsidedown "The recommendation is coming down from the secretary, so the process has just been turned upside down," said William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center and a consultant to the ACIP. Schaffner said the CDC's panel was to vote on these issues at a June meeting, where he had expected them to favor more targeted shots instead of a universal vaccine recommendation. "But this seems to be a bit preemptory," he said. Dorit Reiss, professor of law at UC Law San Francisco, said in a Facebook post that going around the advisory committee might hurt the agency in the case of potential litigation. READ MORE: WHO adopts pandemic accord without US as RFK Jr. confirms Washington's withdrawal Studies with hundreds of thousands of people around the world show that COVID-19 vaccination before and during pregnancy is safe, effective, and beneficial to both the pregnant woman and the baby, according to the CDC's website. But Makary said in the video that there was no evidence that healthy children need routine COVID shots. Most countries have stopped recommending it for children, he added. COVID vaccine makers Moderna and Pfizer did not respond to requests for comment. Dr. Cody Meissner, professor of pediatrics at Dartmouth, who co-wrote an editorial with Makary during the COVID pandemic against masks for children, said he agreed with the decision. He said he felt the US had been overemphasizing the importance of the COVID vaccine for young children and pregnant women, and that previous recommendations were based on politics, adding that the severity of the illness generated by the virus seems to have lessened over time in young children.
