Incannex Healthcare Inc releases groundbreaking results from psilocybin trial to treat anxiety, moves to Phase 2b FDA trials.
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#MAPSPublicBenefit Corporation on Tuesday announced it has filed a New Drug Application with the United States Food and Drug Administration (FDA) for MDMA-assisted therapy in patients with post-traumatic stress disorder (PTSD) which, if approved, would mark the first psychedelic-assisted therapy. With the FDA granting #MDMA Breakthrough Therapy designation in 2017, the company has requested a priority Review of the NDA. According to MAPS PBC, the FDA has 60 days to determine if the NDA will be accepted for review and if its review will be priority or standard, taking six months or 10 months respectively. Should the NDA be approved, the Drug Enforcement Agency would need to reschedule MDMA to make it available for prescription medical use. The NDA follows numerous studies including two late-stage studies evaluating the efficacy and safety of MDMA-assisted therapy. More at #Proactive #ProactiveInvestors http://ow.ly/yvkE1055rli
MAPS PBC submits first-ever NDA for MDMA-assisted PTSD therapy
proactiveinvestors.com
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🧠 Amid a shortage of mental health providers, millions of adult patients are suffering from major depressive disorder (MDD), yet few evidence-based solutions without side effects exist. 💊 Click Therapeutics, Inc. is charting a new course by setting standards for bringing innovative software products to market as prescription medical treatments. 💡 Recognizing the urgent need for evidence-based solutions to address the shortage of mental health providers and the prevalence of MDD, Click Therapeutics developed Rejoyn, a groundbreaking digital therapeutic for the treatment of MDD symptoms. 🔬 But Click didn't just settle for a traditional approach. They took a bold step by engaging with the FDA to understand the rigorous evidence requirements necessary for demonstrating Rejoyn's safety and clinical performance – similar to the standards set for pharmaceutical drugs. ⚒️ Using this non-traditional approach, Click identified the specific requirements and specifications tailored to Rejoyn's unique capabilities in MDD for the 510(k) regulatory pathway. This case study showcases the FDA's nimbleness in regulating innovative treatments and Click's dedication to evidence rigor and market innovation! 🔗 Explore the full case study and discover how Click Therapeutics is changing lives through targeted digital interventions: https://bit.ly/3Kp3NUl
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Umbereen S. Nehal, MD, MPH: "...The topic of deprescribing is relevant to adults of any age who have been refilling the same prescription for years. 'This should be a question we ask with virtually every chronic condition we take care of,' University of Colorado neurologist John Corboy, MD, MA, noted in an interview." https://lnkd.in/gTAv6Vrx #medicine #pharmaceuticals #healthcarefuture
Why Physicians Don’t Deprescribe Medicines
jamanetwork.com
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A “truly remarkable” form of #LSD has reportedly been granted ‘breakthrough therapy’ status by the US FDA after showing promise against Generalised Anxiety Disorder #GAD in phase 2b clinical trials. > The move comes after a single dose of the lysergide d-tartrate treatment - known as MM120 - achieved a “clinically and statistically significant” reduction in anxiety after a single oral dose. > According to biopharma company MindMed, which is developing the drug and conducted the trials, improvement in GAD symptoms was noted within two days of patients taking the drug. > The data – which also showed a 65% clinical response rate and 48% clinical remission rate after 12 weeks – persuaded the FDA to work closely with MindMed to assess MM120 in larger phase 3 trials. #ScienceForASaferWorld #MentalDisorders #neurodegenerativediseases
FDA Grants Breakthrough Therapy Status To LSD Drug To Treat Anxiety
social-www.forbes.com
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Subcutaneous Ocrelizumab Provides New Administration Opportunities for Multiple Sclerosis: Subcutaneous ocrelizumab can be delivered in approximately 10 minutes and deliver comparable clinical benefit and safety to the IV formulation. #finance #pharmacy #lifesciences
Subcutaneous Ocrelizumab Provides New Administration Opportunities for Multiple Sclerosis
pharmacytimes.com
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Deputy Director at Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Based on recent statistics, up to 14% of women experience chronic pelvic pain, which can be disabling and associated with other chronic health conditions. Only a third of those women seek medical care. We need progress in this area, pain does not need to be normal. NICHD is grateful for partnership with FDA in this area. Join this upcoming workshop to learn more! #NICHDImpact #Womenshealth #pelvicpain #endometriosis #adenomyosis #painresearch
Join NICHD on June 13 at 1 p.m. ET for the Gynecologic Pain Research Virtual Meeting. Established and new investigators in the field of gynecologic pain research will share recent research findings and discuss progress, challenges, and potential future directions. Staff from the U.S. Food and Drug Administration (FDA) will also provide an overview of the FDA review of gynecological devices and investigational new drug (IND) processes. Register today at https://go.nih.gov/YV3sBOX. #ReproductiveHealth #WomensHealthNICHD
Third Annual Gynecologic Pain Research Virtual Meeting
nichd.nih.gov
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Comparative Analysis of #Opioids and #Cannabis for Chronic Non-Cancer #Pain Let’s start from the conclusion: “Cannabis for medical use may be similarly effective and result in fewer discontinuations than opioids for chronic non-cancer pain”. This is the conclusion of a recent systematic review and network meta-analysis which delves into the comparative #benefits and #harms of opioids and cannabis for medical use in managing chronic non-cancer pain. Spanning 90 trials with 22,028 patients, the findings offer important insights. · Opioids show moderate-certainty evidence of providing slight improvements in pain, physical functioning, and sleep quality compared to placebo. · Cannabis for medical use exhibits low to moderate-certainty evidence, suggesting similar effects to opioids against a placebo. · Neither opioids nor cannabis demonstrate superiority to placebo for role, social, or emotional functioning (high to moderate certainty). · Moderate-certainty evidence indicates little difference between cannabis and opioids in terms of physical functioning. · Cannabis users experience fewer discontinuations due to adverse events compared to opioid users. · Low-certainty evidence suggests minimal difference between cannabis and opioids in pain relief and sleep quality. This analysis indicates that cannabis for medical use might offer comparable effectiveness to opioids for chronic non-cancer pain, with the added benefit of fewer discontinuations due to adverse events. For those interested in the role of Medical Cannabis in chronic pain management and beyond, our #handbook, "Principles of Clinical Cannabinology," awaits an exploration. Comprehensive and insightful, it encapsulates everything you need to deepen your understanding: https://lnkd.in/debSUPpQ Yours in Science, Cannabiscientia SA
Cannabis for medical use versus opioids for chronic non-cancer pain: a systematic review and network meta-analysis of randomised clinical trials
bmjopen.bmj.com
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📢 Exciting News for CIDP Patients! I'm happy to hear the news that offers a new treatment option for those living with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Working with PTCE, I've learned so much about CIDP by collaborating with expert clinicians, understanding medication challenges from pharmacists and nurses, and even had the privilege of talking to a couple fantastic patient advocates. Their stories highlight the need for effective treatments. On Friday, argenx announced the FDA approval of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), a neonatal Fc receptor (FcRn) blocker. This is the first new treatment mechanism in over 30 years, offering hope and a new option for patients. Efgartigimod alfa and hyaluronidase-qvfc showed significant improvements in mobility, function, and strength in clinical trials. Let's celebrate this monumental step forward in CIDP treatment! #CIDP #PatientCare #NewTreatment #FDAApproval #efgartigimod #argenx #HealthcareInnovation #PTCE
FDA Approves Efgartigimod Alfa and Hyaluronidase for CIDP
ajmc.com
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Slow-Release, Oral Ketamine Tablet May Reduces Severity of Treatment-Resistant Depression: The authors note that the oral, at-home treatment can a better alternative for patients by reducing inconveniences that come with the injectable and nasal administration methods. #finance #pharmacy #lifesciences
Slow-Release, Oral Ketamine Tablet May Reduces Severity of Treatment-Resistant Depression
pharmacytimes.com
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"The respective trajectories of two medications – one that helps obese people lose weight, the other highly effective at preventing heart attacks and strokes – illustrate the forces driving biomedical innovation in the United States... GLP-1 drugs are here to stay. Unfortunately, their high cost and popularity have put state health plans in a bind. An estimated two million Americans have turned to compounding pharmacies for inexpensive versions of semaglutide and tirzepatide, the active ingredients in Novo Nordisk and Eli Lilly’s drugs. This is legal under FDA guidelines when a brand-name drug is in shortage. As for the polypill, perhaps the rising toll of cardiovascular disease in the U.S. and globally will prompt reconsideration of its potential. In a Washington Post op-ed earlier this year, former CDC Director Tom Frieden wrote, 'Hypertension, the ‘silent killer,’ is the deadliest but most neglected and widespread pandemic of our time, killing more than 10 million people a year worldwide' In August, an American College of Cardiology report noted 'persistent and tragic inequities' in cardiovascular care among Black Americans...the report’s senior author observed that 'Black Americans, because of their higher cardiovascular mortality rates compared with white Americans, have suffered almost 800,000 excess deaths, which translates to about 24 million additional years of life lost between 2000 and 2022. This staggering figure highlights the critical need for systemic changes in addressing cardiovascular inequities.' The polypill could play a key role in solving these challenges." #Innovation #GLP1" #Polypill https://lnkd.in/egnqVzJx
What Two Drugs Tell Us About Medical Product Innovation In The U.S.
social-www.forbes.com
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