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New peripheral neuropathy drug gets FDA advance
FDA has just accepted Vertex’s New Drug Application related to suzetrigine for priority review in late January, 2025. The drug appears likely to be approved. Here us an excerpt from a Vertex communication:
Suzetrigine (formerly VX-548) is an investigational oral, selective NaV1.8 pain signal inhibitor that is highly selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). NaV1.8 is a genetically validated target for the treatment of pain, and suzetrigine has demonstrated a favorable benefit/risk profile in three Phase 3 studies and two Phase 2 studies in patients with moderate-to-severe acute pain. Suzetrigine also demonstrated positive results and a well-tolerated profile in a Phase 2 study in patients with pain associated with diabetic peripheral neuropathy, a type of chronic peripheral neuropathic pain. Vertex’s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of pain signal inhibitors that have the potential to provide effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.
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I want to let everyone know that Winsantor is continuing in its efforts to bring its first-of-a-kind disease modifying drug to market as well as implementing its FDA-sanctioned compassionate use program utilizing the drug while pending approval. It needs more people to sign up for this program before it can start the program. I received this communication from Winsantor today:
Phase 3 Trials: Progress and Next Steps In parallel, we have been working tirelessly to secure funding for our Phase 3 trials, which will involve approximately 700 patients globally. We are finalizing negotiations with several funding sources and expect to have the necessary resources soon. Once secured, we aim to launch both the Phase 3 trials and the Compassionate Use Program in the U.S. and other countries.
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12 ReactionsIs there a link to get more information and/or to sign up for the trial?
Google gave me this: https://winsantor.com/join-us-for-news-and-upcoming-trials/#subscription-form
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3 ReactionsI am also interested in signing up for the new drug trial. How do we do this? Who do we contact?
Tks
Debbie
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1 ReactionIt's a medication for diabetic peripheral neuropathy, not non diabetic for those interested.
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1 ReactionGo to winsantor.com
The clinical trial are being done on diabetic person because they are a good control group but the drug will be available for all types.
I’ve had PN for years now and I have no pain, just weakness and tingling in my feet. I also have balance issues. I take zero meds for my PN. Why do soooo many people have pain issues and I don’t? I had to retire early as I didn’t have the strength to get the left brake pedal down hard enough and when you’re landing on a 6000 ft runway at 120kts. You have to get it stopped. There’ll never be a cure for this crap.
I had to quit driving when I could no longer feel the brake pedal after PN from chemo. I don't have pain, just numbness. I do use gabapentin. My problem has gone on for 4 years.
My balance also suffered a lot. Recently, I started using one of the under- the desk- elliptical's and my balance is a lot better, plus I no longer get cramps in my legs in bed. It only cost me $109 on Amazon. I'm 83. I've started doing more again and am planning a trip to Cancun with my kids. Last month I took a sleeper home from Portland. OR to California on the train by myself. Try one!
Sounds like you are doing well. I like the under the desk elliptical idea and will look into it. I have tried various TENS and EMS devices without much success but believe a vibration plate device (Amazon has several) has been helpful and I use it most days. Despite considerable PN in both feet, legs, face, arms I travel internationally several months each year and try to walk several miles or swim daily.