Thomas Cruchter’s Post

Suzetrigine (VX-548): A Non-Addictive NaV1.8 Inhibitor with Ph. III Pain Efficacy Comparable to Vicodin | https://lnkd.in/gsadFyv9 -2023 Molecule of the Year Nominee (3//10)- Vertex Pharmaceuticals' suzetrigine (VX-548) is a potential first-in-class, exquisitely selective, oral NaV1.8 inhibitor that recently captured headlines for its positive Ph. III data. With nearly 51.6 million adults in the US experiencing chronic pain each year, coupled with the ongoing opioid epidemic throughout the US, there is an urgent unmet medical need for non-addictive pain medications as alternatives to opioids. Vertex Pharmaceuticals plans to file an NDA for VX-548 by mid-2024 for the treatment of moderate-to-severe acute pain which has further ignited industry interest in NaV1.8. This case study highlights what’s publicly known about Vertex’s journey in pain leading up to the Ph. III readout for VX-548, why this molecule is a big deal, and why it’s a 2023 Molecule of the Year Nominee. Full Article | https://lnkd.in/gsadFyv9

Targeted Drug Delivery (TDD) therapy isn't just about easing pain; it's a valuable therapy to help patients return to their everyday activities.¹ The Control Workflow™ approach to TDD uses low-dose therapy as a treatment option for chronic pain, offering a practical option to minimize systemic opioid use while maintaining effective pain relief.²,³ Incorporating this approach could assist in overcoming perceived obstacles to TDD therapy. Surgical, device, and drug complications can occur that may be life-threatening or fatal. See risk information here: https://bit.ly/3LrZt7m To learn more about Control Workflow™, check out our webpage for more info: https://lnkd.in/gNJ4Q8_n #MDTPainInterventions #TDD #ControlWorkflow #TDDSynchromedIII ¹ Hamza M, Doleys DM, Saleh IA, et al. A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain. Neuromodulation. 2015 Oct;18(7):636-48. ² Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10):1304-1313. ³ Grider JS, Etscheidt MA, Harned ME, et al. Trialing and maintenance dosing using a low-dose intrathecal opioid method for chronic nonmalignant pain: a prospective 36-month study. Neuromodulation: journal of the International Neuromodulation Society. 2016;19(2):206-219.

What are the benefits of targeted drug delivery (TDD) for patients with chronic pain? TDD has been proven to provide patient satisfaction (1,2) by delivering effective pain relief (3,4) along with improving the patient's ability to function and participate in day-to-day activities. (1) This patient's experience illustrates some of the potential benefits TDD can have for people dealing with chronic pain. Surgical, device, and drug complications can occur that may be life-threatening or fatal. See risk information here. https://shorturl.at/ouxG1 This information is based on one patient's experience. Results may vary. #MDTPainInterventions #TDD #ControlWorkflow #TDDSynchromedIII (1) Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic non-cancer pain. Eur J Pain. 2001;5(4):353-361 (2) Schultz DM, Abd-Elsayed A, Calodney A, et al. Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry. Neuromod. 2021;24(7):1167-1175. (3) Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10): 1304-1313 (4) Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5(1):6 13

We know there are a lot of questions that come with a new FDA approved medication! We hope to answer a few that may be top of mind about Rezdiffra™ (resmetirom). 1. What is Rezdiffra? A new drug called Rezdiffra, an oral thyroid hormone receptor beta- selective agonist, shows promising results in treating Nonalcoholic Steatohepatitis (NASH), now known as metabolic dysfunction-associated steatohepatitis (MASH). 2. What's the big deal? The availability of the first NASH drug,  Rezdiffra, marks a significant advancement in the treatment landscape for NASH, offering hope for improved liver health and overall outcomes. 3. Who can take Rezdiffra?  Rezdiffra is for patients with noncirrhotic Nonalcoholic Steatohepatitis (NASH) with moderate to advanced liver fibrosis. 4. Are there side effects? Like all medicines, Rezdiffra can have some side effects. Some people experienced nausea or diarrhea more often than those who took a placebo (a pill with no medicine in it). However, serious side effects were rare, which is reassuring. 5. Who can I call to talk to about Rezdiffra? The team at Arizona Liver Health is well-equipped to answer any questions about Rezdiffra, and to help determine if Rezdiffra is the right choice for your patients. Check out our website www.azliver.com or give us a call for patient referrals. #Rezdiffra #newmedication #arizonaliverhealth Naim Alkhouri Anita Kohli Richard Manch Ann Moore Yessica Sachdeva David Rios, MD Reichard R. Tessa Janovsky Mazen Noureddin, MD, MHSc Julio Gutierrez MD Meena Bansal Raj Vuppalanchi Elliot Tapper Fatty Liver Alliance Madrigal Pharmaceuticals Summit Clinical Research Michelle Jones Nick Engelke Kelly Black Anne Payne Desirae Trotter John Raslavsky

Important- research all potential side effects to determine if the positive benefits outweighs the negative. Diet & lifestyle have to be part of the treatment, as well as prevention. 

What do you mean, you've still got stomach pain? Did you REALLY take your medication? - In a number of population groups, 20% (or more) of individuals carry the CYP2C19*17 allele variation. This means that they are classed as rapid or ultrarapid metabolisers and will likely fail to respond to treatment with proton pump inhibitors (PPIs) at usual doses as they will be unable to sustain therapeutic drug plasma concentrations. This can have serious consequences in patients being treated for H. pylori, but is also quite miserable for patients with reflux. CPIC guidelines recommend using an increased starting dose: 50% in rapid metabolisers, 100% in ultrarapid metabolisers. For ultrarapid metabolisers with the *17/*17 genotype, DPWG guidelines go as far as recommending a 3- to 5-fold dose increase, depending on the drug selected: omeprazole, pantoprazole or lansoprazole. (For those with just one *17 allele, no dosage adjustment is required under these guidelines.) Pharmacogenomic testing should be considered in PPI treatment failure. Your patients will thank you. ----- Kia ora. 👋 I'm Claire. I’m a pharmacist on a mission to empower patients with personalised medication based on their unique genetic makeup. I partner with healthcare providers to provide prescribing guidance that is relevant and actionable for personalised medication management. Click my name + visit my website🎯 #precisionmedicine #pharmacogenetics #pharmacogenomics #pharmacist

Very exciting update on ATAI Life Sciences AG's and Beckley Psytech's Phase 1/2a trial of ELE-101 for Major Depressive Disorder (MDD). ELE-101 is a patent-protected, intravenous formulation of psilocin, which is the active moiety in the body when psilocybin is administered orally. As such, I view ELE-101 as a relatively de-risked asset for its stage of development, as it leverages the robust proof-of-concept data that has been established with psilocybin across multiple trials. Especially, it has the potential to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter (!) treatment paradigm of less than 2 hours. So much larger TAM/business upside. #psychedelics #investing #future

"A low-dose triple single-pill combination was effective at lowering blood pressure (BP) in two trials presented in a Hot Line session today at ESC Congress 2024. "Globally, most people treated for high BP do not achieve adequate control, primarily due to continued use of low-efficacy regimens including monotherapy. Single-pill combinations of different low-dose drugs hold promise for improving hypertension management by virtue of additive benefits, rapid action and a low risk of adverse events. "We developed a triple single-pill combination, GMRx2, and tested this in a placebo-controlled trial to assess the product as a whole, and in a trial against three different dual therapies, to assess each component one by one. We are encouraged by the clinically meaningful BP improvements observed," explained Principal Investigator, Professor Anthony Rodgers of the George Institute for Global Health, University of New South Wales, Australia." #bloodpressure #clinictrial

This week, a selection of expanded #pharmacotherapy topics w/ #PMT #JPharmTechnol - novel treatments of crizanlizumab for #sicklecelldisease (Stevens et al https://lnkd.in/eAg33zxa ) + lasmiditan for acute #migraine (Beauchene & Levien https://lnkd.in/esBCGHWA) #pharmacists #womenshealth #diseasemanagement #monoclonalantibodies

Improvements in formulations may contribute to #competitive advantage. For instance, in neurodegenerative disease treatments updates, Amneal Pharmaceuticals scores the approval for its updated carb/levodopa formulation, Crexont, for use in Parkinsons Disease, which intends to work fast and last. 🧠 "Crexont demonstrated a statistically significant improvement of 0.5 hours of additional “Good On” time per day — defined as minimum Parkinson’s symptoms without troublesome dyskinesia — with an average of thrice-daily dosing, versus five times a day dosing for the IR formulation." #NeurodegenerativeDisease #ParkinsonsDisease #Crexont #Regulatory #Pharma #Healthcare https://lnkd.in/enHD6b2n