medicinal-cannabis
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The NSW Government has committed $3.5 million to fund clinical trials exploring the use of cannabis products to provide relief for children with severe drug-resistant epilepsy. Researchers at Sydney Children's Hospitals Network will lead trials of CBDV and Epidiolex, drugs manufactured by GW Pharmaceuticals that have shown promising anti-seizure effects. The first trial will evaluate CBDV for children with epilepsy, while a compassionate access scheme may also allow children to access Epidiolex. The goal is to develop a better understanding of how these cannabis-derived drugs can help reduce seizures.
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The document outlines an innovative approach to drug development using cannabinoid prodrugs to treat various serious medical conditions, including inflammatory bowel disease and opiate dependence. It emphasizes the unique use of glycosylation technology for targeted delivery, highlighting the lack of existing drug companies capable of obtaining necessary approvals. Additionally, it details the company's development pipeline and intellectual property strategy, including patents for over 20 novel cannabinoid glycoside prodrugs.2019 A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine f...
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This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of pseudoephedrine hydrochloride 30-mg tablets for temporary relief of nasal congestion in children aged 6 to 11 years with the common cold. Pseudoephedrine was found to be superior to placebo in reducing nasal congestion severity over the first 8 hours after dosing on day 1. Somnolence was reported more frequently in children taking pseudoephedrine compared to placebo, while similar percentages reported insomnia and nervousness. Multiple doses of pseudoephedrine for up to 7 days was generally safe and provided temporary relief of nasal congestion symptoms in children with the common cold.Canadas Orphan Drug Regulatory Framework & panCanadian Access to Rare Diseas...
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Dr. Greenberg CORD Mar 23-24, 2022 Rare Drug Strategy WebinarDay
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Ad
medicinal-cannabis
- 1. www.health.nsw.gov.au MEDICINAL CANNABIS CLINICAL TRIALS FOR CHILDREN WITH SEVERE EPILEPSY These trials are part of the NSW Governments commitment to develop a better understanding of how cannabis products can provide relief to children with severe drug-resistant epilepsy. NSW researchers at the Sydney Childrens Hospitals Network, Dr John Lawson and Dr Deepak Gill, will lead the development and conduct of these trials using cannabis-derived products that are manufactured and supplied by GW Pharmaceuticals. GW Pharmaceuticals GW Pharmaceuticals is a world leader in the development of prescription cannabinoid medicines. The company has a pipeline of cannabinoid products, including Epidiolex速 which is in Phase 3 clinical trial studies for the treatment of certain types of severe childhood epilepsy syndromes. A world first partnership A NSW partnership has now been established with GW Pharmaceuticals to hold the worlds first medicinal cannabis trial for children with severe drug-resistant epilepsy using a new cannabis-derived drug, CBDV (cannabidivarin). The new partnership with GW may also allow eligible children to be part of additional further clinical trials using Epidiolex速. This drug is a cannabidiol-based medicine currently used in international clinical trials. The new partnership facilitates four key outcomes for NSW: a world first phase 2 clinical trial for a novel product, cannabidivarin (CBDV) a compassionate access scheme for Epidiolex速 provision for NSW to host future clinical trials of GW products. a phase 4 clinical trial of Epidiolex速 (based on success of phase 3 studies) About Epidiolex速 Epidiolex速 is a product developed by GW, which contains the non-psychoactive cannabinoid, CBD (cannabidiol). Epidiolex速 is taken in the form of an oral liquid and is currently in Phase 3 trials internationally. Epidiolex速 has shown positive results in a compassionate use scheme in the United States. Epidiolex速 contains CBD. This drug is being investigated overseas for the treatment of various rare childhood epilepsy syndromes. About CBDV CBDV is a molecule in the cannabis plant that has shown promising results as an anti- convulsant, and for which GW Pharmaceuticals already has phase 1 clinical trial results in adults. CBDV does not produce the psychoactive (mind-altering) effects associated with herbal cannabis containing high levels of THC. The NSW Government has committed $3.5 million to explore the use of cannabis products in providing relief for children with severe drug-resistant epilepsy.
- 2. About the trials Each trial will have a specific number of participants. This number will be carefully calculated to ensure the study can achieve the most accurate scientific result in the shortest possible time. All trials will be conducted in accordance with good practice for clinical trials and be subject to regulatory approval including review and approval by an appropriate Human Research Ethics Committee. Researchers will be designing the first of the trials over the coming months and are expected to advertise for participants in 2016. Participating in the trials The first trial is expected to commence in 2016 following ethics approval. At that stage researchers will advertise for interested participants and publish information on: who can participate in the trial (eligibility criteria) reasons why some children would not be able to participate (exclusion criteria) how researchers will measure the outcomes (eg: by tests or seizure diaries). Once advertising for participants occurs it is best to meet with your childs doctor to discuss their condition and whether they might be suitable for participation in the trial. This is a NSW based trial. Residents from other states and territories in Australia will need to await further information on potential study hospital sites and local involvement. It is best to talk to your local specialist doctor about whether your child may be able to participate. Further information will be available as the trials program is developed. Compassionate access scheme for Epidiolex速 From 2016 the new partnership with GW Pharmaceuticals allows compassionate access for a small number of children to Epidiolex速. This scheme would be for a small number of children who are not able to participate in a clinical trial due to the unrelenting nature of their epilepsy which has not responded to proven treatments. Details on this scheme will be publicised as soon as available. General information For more information: call the Cannabis Trials Help Line on 1800 217 257 write to Cannabis Trials, NSW Ministry of Health, Locked Mail Bag 961, North Sydney, NSW 2059 email the NSW Ministry of Health on cannabistrial@doh.health.nsw.gov.au Information about Epilepsy Services in NSW: Paediatric Epilepsy Network - http://www.pennsw.com.au/ www.health.nsw.gov.au