We've submitted today, a request to the US Food and Drug Administration (FDA) for orphan drug designation for the use of NTI164 in children and adults diagnosed with Rett Syndrome. If granted, ODD could provide several incentives, including tax credits, exemption from user fees, and seven years of market exclusivity upon approval. Rett Syndrome is a rare neurological disorder affecting approximately 15,000 girls and women in the US and 350,000 globally, with the global market estimated at over $2 billion annually. A response from the FDA Office of Orphan Products Development is anticipated within 90 days of filing. Read the full ASX Announcement here: https://lnkd.in/gNThDbGC #NTI #Neurotech #biotech #RettsSyndrome #NTI164 Ontario Rett Syndrome Association
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Yesterday, Neurotech International Ltd reported positive results from their ongoing Phase I/II #clinicaltrial in Australia of NTI164, a broad-spectrum cannabinoid drug therapy for the treatment of #Rettsyndrome. After 12 weeks with no SAEs, the company reported that 93% of participants showed improvement based on the CGI-I scale and that the mean improvement from week 4 to 12 on the RSBQ was 205% in symptoms including communication, hand behaviors, anxiety/mood, and quality of life. More results: https://lnkd.in/gse8kkgm Rett syndrome is a complex disorder that requires multiple approaches. IRSF won’t stop until we find solutions for ALL. For more about all Rett syndrome programs in the pipeline and the research we fund, visit our website: https://lnkd.in/gQYpibc
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Healthcare Professional, Business Development, Mental Health Advocate, Specialty Sales • I enjoy cross-functional teamwork and focus on Consultative Selling
Opioid Misuse as an Attachment Disorder with Michael Roeske, PsyD The origins of the opioid epidemic are often attributed to an unscrupulous pharmaceutical company. But a more useful approach to viewing opioid use disorders and their treatment is through two discrete yet interconnected lenses: the larger ecological system, including sociohistorical changes in the United States; and attachment theory, which sees connection-seeking behaviors as primary to survival. This presentation will explore aspects of both lenses, posit a causal link to the increase in opioid misuse, and present considerations for the field. Registration Link: https://lnkd.in/g9HMKu9r
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Board chairman & CEO of PharmGo Ltd.,Co, Board member of directors of International Society of Pharmaceutical Engineering (ISPE) China, Chairman of ISPE China Gene & Cell Committee
The information and tools that C-Path provides may support your innovative drug development.
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Nurse Practitioner | Ph.D. in Nursing Science | MBA/MS Candidate | KOL in Diabetes Care | Healthcare & Community Leader | Nonprofit Board Member | Dedicated to Patient-Centered Care & Health System Innovation | Mentor
💊Polypharmacy in T2D on the Rise! 📈 Managing comorbidities and curbing CVD is vital, but so is being aware of the risks. 🚨 Drug interactions, adverse effects, and the challenges of over/underprescribing are crucial to address. Stay informed and stay safe! 💊✨ #Healthcare #Diabetes #T2D #Polypharmacy #CVD #MedicalAwareness
Increasing Medication Use and Polypharmacy in Type 2 Diabetes: The Danish Experience From 2000 to 2020
diabetesjournals.org
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Happy Independence Day! 4 of July is a time for Americans to remember and reflect on the principles of freedom and democracy that their country was founded upon. Today we honor the brave men and women who fought for their independence and remember the sacrifices that were made to secure the nation's freedom. https://lnkd.in/eM7UtE-8 #IndependenceDay #USA #GCT #GlobalClinicalTrials #CRO #clinicalresearch #drugdevelopment #medicine #pharma #clinicaltrials #clinicaltrial #gctrials #research
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The rising rate of unintentional pediatric cannabis ingestions in the U.S. has become a public health concern. Unfortunately, diagnosis of THC ingestion can often be delayed, as urine drug screens often take over an hour to return a result. And in states like Wisconsin where THC is illegal, pediatric patients are more likely to need imaging and other resources. Read how AHW seed grant funding will help Medical College of Wisconsin researchers validate rapid urine THC testing with high sensitivity and faster turnaround time, with an overall goal of reducing investing testing for THC ingestion in children. 🔽 https://lnkd.in/gzAci_PN #AHWEndowment #WisconsinHealth #DrugTesting
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A 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. Toronto Research Chemicals provides a wide range of chemical tools that support #DrugDiscovery and research into #MentalDisorders and #neurodegenerative diseases. Explore more at https://okt.to/AkOjKh #ScienceForASaferWorld
FDA Grants Breakthrough Therapy Status To LSD Drug To Treat Anxiety
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FDA Approves Cobenfy: 1st New Schizophrenia Drug in 30 Years With World Mental Health around the corner, Cobenfy, made by Bristol Myers Squibb, is now approved. What’s unique? ✅ Combines two drugs (xanomeline + trospium chloride). ✅ Targets acetylcholine, a new approach after decades of focusing on dopamine. Why it matters: ➡️ Reduces hallucinations, delusions, and disorganized thinking. ➡️ Fewer side effects - only 6% stopped due to side effects (vs. 20-30% with older meds). ➡️ Offers hope for patients who haven’t responded to existing treatments. With schizophrenia affecting 24 million worldwide, this approval brings new possibilities for treatment and care. Doctors could start prescribing Cobenfy by the end of October #mentalhealth #pharma #biotech #FDA #CRO
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When we talk about types of clinical studies, the first thing to clarify is the purpose, and the basic difference is to divide them between intervention studies and observational studies. In intervention studies, as the name implies, the researcher measures the effect of one or more interventions comparatively with another intervention or a placebo; while in observational studies, only observation and collection of information in real-life situations occur, without intervening in the course of events. That is, participants do not undergo any treatment. The Food and Drug Administration (FDA) provides a more detailed description of the types of clinical studies. Below, we detail them. #clinicaltrial #clinicaresearch #cro #latamcro #BOPALcro
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MindMed, a biotech company specializing in psychedelic-inspired medicines, has revealed promising results from its MM-120 drug candidate in the treatment of Generalized Anxiety Disorder (GAD). The results from a recent clinical trial showed that the MM-120 — a hallucinogen better known as LSD — could become a potential new treatment for GAD, a condition that affects millions of people worldwide. The trial highlight that the drug candidate, particularly at the 100 µg dose, demonstrated effectiveness, significantly reducing anxiety symptoms. Learn more right here: https://lnkd.in/g2pZJ-Wr Never miss an opportunity to learn and subscribe to our email list: https://lnkd.in/g3Ps94t ————————————————————— #diversityinclinicalresearch #clinicaltrial #diversityinmedicine #diversitymatters #diversity #diversidad
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