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Yahoo
15 minutes ago
- Yahoo
Praxis' Epilepsy Treatment Shows Promise With Decreased Seizures
Praxis Precision Medicines, Inc. (NASDAQ:PRAX) stock experienced a volatile trading session on Monday, after the company announced positive topline results from its Phase 2 RADIANT study evaluating vormatrigine in patients with focal onset seizures and generalized epilepsy. The stock initially surged on the news, but then reversed course and is currently trading down approximately 9%. The central nervous system (CNS) disorders-focused company said the topline results from the Phase 2 RADIANT study included data from 37 patients.'These findings build on our earlier clinical data showing a differentiated profile for vormatrigine as a fast-acting, no-titration, once-daily oral drug with no requirement to be taken with food, and a favorable DDI profile, all of which are unseen in ASMs currently in the market or in development,' said Marcio Souza, president and CEO of Praxis. In an investor presentation on the company website, Praxis noted that the trial showed a median seizure reduction of around 56.3%, with 60% of the patients achieving at least a 50% reduction in seizures. This positive outcome has encouraged the company to move forward with a Phase 2/3 trial, even though 23% of patients discontinued the study. 54% of patients achieved at least a 50% seizure reduction threshold in Week 1 and 67% in Week 8. In the last month of the dataset, 22% of the patients experienced a 100% reduction in seizure frequency. The company added that most adverse events were mild to moderate and transient. All severe and serious adverse events (AEs) were recovered and resolved. The investor presentation noted that the investigators had the option to reduce the dose of the background medication to manage AEs; when done (6 patients), no discontinuation was observed. The company said it is on track to complete the pivotal, 12-week POWER1 study in the fourth quarter of 2025 and, based on the results from RADIANT, it expects to initiate the POWER2 study shortly. On Monday, the company reported cash and investments of approximately $447 million and maintains a cash runway into 2028. In July, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Praxis Precision's relutrigine, a sodium channel functional state modulator for pediatric use for SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). The EMBOLD cohort 2 pivotal trial is on track for topline results in the first half of 2026, with NDA filing to follow. Praxis has recently initiated the EMERALD study investigating relutrigine broadly in DEEs. Price Action: PRAX stock is trading lower by 9.51% to $48.95 at last check Monday. Read Next:Photo via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Praxis' Epilepsy Treatment Shows Promise With Decreased Seizures originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Medscape
17 minutes ago
- Medscape
Ethics of Artificial Hydration and Nutrition In Dementia
This transcript has been edited for clarity. Hi. I'm Art Caplan. I'm at the Division of Medical Ethics at the NYU Grossman School of Medicine. I had a difficult case brought to me recently by someone who was trying to decide what to do with a patient with very bad dementia in terms of feeding. It's not the first time I've had this kind of case brought to me by physicians, and it probably won't be the last, but it remains a thorny, tough ethics quandary. I think everybody understands that there is a right — and we've had this affirmed since cases like Terri Schiavo or Nancy Cruzan — to not force artificial feeding (meaning by tube, in the nose, or in the stomach) or artificial hydration upon someone who doesn't want it. If you have the right to refuse treatment, it's been established — certainly in American law, and I would say by standards of care within the medical profession — that hydration and feeding, when they're done by mechanical means, tubes, or using artificial substances to supply nutrition, are medicine. As a medical intervention or a medical therapy, just like other interventions, such as dialysis or even refusing an amputation for a diabetic patient, the patient ultimately, if they're competent, has the right to refuse it. The challenge comes in the case that was presented to me. A woman, let's call her Mary Taylor, some years ago knew that she was at risk of getting Alzheimer's disease. She filled out her living will and discussed with her family that when she became demented, if she was unable to care for herself, if she couldn't recognize her family and friends, she did not want any medical interventions, including specifically hydration and nutrition. Sadly, she went through the course of declining and ended up at a nursing home. At the nursing home, the doctor who was treating her noticed that nurses were offering Mary food on a spoon and liquid on a spoon, that she was opening her mouth when the spoon was presented, and she was, if you will, eating and drinking. The physician, knowing that the family remembered this advance directive living will and knowing that they were the designated decision-makers, basically said stop the spoon-feeding. The nurses did not want to do it. They said it's ordinary care. It's not medical. It's just what you do as part of what one human being deserves from another human being — to offer them ordinary ways to drink water or to eat something. The case basically raises two tough ethics questions. Is feeding by spoon the same as medical intervention with artificial forms of hydration and nutrition? I believe it is. I believe that when you say 'no more food and nutrition,' it isn't just the equipment. I'll put it simply: It's who's on the end of the spoon. If nurses or doctors are feeding, it's medical. It's professional care, and you should be able to say no to that. Secondly, I do think if someone says 'I don't want to eat or drink anymore,' their intent and their values are clear. You could certainly rediscuss it with the family and say she seems to be accepting food and swallowing, and ask if that changes their mind or makes them think she might have decided differently. However, I think the wishes of the competent person, when they made the living will, are what should drive care if the person loses competency. They thought about it, they knew where they were headed, and I do think that's the value that ought to dominate thinking about whether we have to continue to try food and water for nutrition. Does that mean that you can't offer ice, lip balm, or other comfort means if someone is suffering because they're getting dehydrated and so on? Absolutely not. That isn't the same as feeding them. Here are some lessons to consider. It's important to pay attention when someone says they don't want food and water. Are nurses or anyone in a hospital or a nursing home trying to feed them anyway because they don't think of spoon-feeding as an artificial or medical intervention? I think they need education about that, and I think it's important to make sure that does not happen if that's what they said in their advance directives. I also believe advance directives and conversations with people, when they're competent or facing the potential loss of competency, should include discussions about whether they really mean everything, such as spoon-feeding or somebody offering you a glass of water. Is that included in what you are saying you do not want? We have to be thorough and comprehensive in making sure that we're clear so there really aren't disputes of what people did say no to and might say yes to if they no longer are able to tell us directly. I'm Art Caplan, at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thank you for watching.
Medscape
17 minutes ago
- Medscape
Three FDA-Approved Obesity Drugs That Aren't GLP-1s
This transcript has been edited for clarity. There are currently three FDA-approved oral medications for the long-term treatment of obesity that are not GLP-1 based. Alli or Xenical (generic name orlistat) was approved by the FDA in 1999. It works by inhibiting intestinal lipase and it reduces absorption of dietary fat by up to 30%. Common side effects are gastrointestinal and include fatty or oily stool, fecal urgency, and incontinence. The average placebo-subtracted weight loss is about 3.8%. Alli is the only FDA-approved medication available over the counter. Qsymia is a combination of phentermine and topiramate and was approved by the FDA in 2012. Phentermine is a sympathomimetic, and topiramate is a neurostabilizer that enhances GABA activity. Clinically, the combination pill enhances satiety, decreases appetite, and reduces binge eating behaviors. Common side effects are paresthesias, altered taste, tachycardia, irritability, hypertension, insomnia, and dry mouth. It is currently one of the most effective oral medications, with an average placebo-subtracted weight loss of 8.6%. Contrave is a combination pill of bupropion and naltrexone and was approved by the FDA in 2014. Bupropion is a norepinephrine and dopamine reuptake inhibitor, and naltrexone is a mu opioid receptor antagonist. Clinically, it decreases appetite and cravings. The common side effects are nausea, vomiting, insomnia, constipation, dry mouth, diarrhea, and dizziness. The average placebo-subtracted weight loss is 4.8%.
