FDA Grants Psilocybin Second Breakthrough Therapy Designation for Resistant Depression Megan Brooks Medscape Medical News © 2019 November 25, 2019 The US Food and Drug Administration (FDA) has granted the Usona Institute breakthrough therapy designation for psilocybin for the treatment of major depressive disorder (MDD). This marks the second time the FDA has granted breakthrough designation for psilocybin, the psychoactive ingredient in "magic mushrooms." In October 2018, Compass Pathways received the designation to test the safety and efficacy of psilocybin-assisted therapy for treatment-resistant depression, as reported by Medscape Medical News. "The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is [...]
Lire la suiteFDA Okays New Indication for Esketamine Nasal Spray Megan Brooks Medscape - Aug 03, 2020. The US Food and Drug Administration (FDA) has approved the supplemental new drug application for esketamine nasal spray (Spravato, Janssen Pharmaceuticals) to treat depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior. The FDA approved esketamine nasal spray for treatment-resistant depression in March 2019, as reported by Medscape Medical News. The new indication is based on data from two identical phase 3 trials — ASPIRE I and ASPIRE II — which evaluated the efficacy and safety of the nasal spray in addition to a comprehensive standard of care [...]
Lire la suiteCannabis Misconceptions Still Common Among MS Clinicians Nancy Melville June 05, 2020 https://www.medscape.com/viewarticle/931872?nlid=135873_425&src=WNL_mdplsfeat_200609_mscpedit_psyc&uac=292598PZ&spon=12&impID=2413707&faf=1 Despite the ever-increasing acceptance of medical cannabis and its notably common use in patients with multiple sclerosis (MS), clinicians treating those patients still may be poorly informed about risks, benefits, regulations, and proper uses, experts say. "There is evidence of a 'clinical void,' with clinicians on one side and people with MS and other conditions on the other that doesn't usually exist regarding therapies that people with MS are using," said Allen C. Bowling, MD, PhD, director of the NeuroHealth Institute and clinical professor of neurology at the University of Colorado, in Aurora. His [...]
Lire la suiteEtats-Unis : l’Epidiolex n’est plus une substance contrôlée Aurélien BERNARD Newsweed.fr, 8 avril 2020 https://www.newsweed.fr/etats-unis-lepidiolex-nest-plus-une-substance-controlee/ GW Pharmaceuticals a annoncé lundi que l’Epidiolex, un médicament à base de cannabidiol (CBD) utilisé dans le traitement de l’épilepsie, avait été retiré de l’annexe V de la Loi américaine sur les substances contrôlées par la Drug Enforcement Administration (DEA). Les personnes qui pourraient en bénéficier pourront dorénavant en obtenir plus facilement. GW a déclaré dans son communiqué qu’il « entamera maintenant le processus de mise en œuvre de ces changements au niveau de l’État et via le réseau de distribution EPIDIOLEX ». Comme pour de nombreux médicaments non-contrôlés, les malades ou leurs [...]
Lire la suiteAre Your Patients Taking CBD? - Medscape - January 15, 2020 https://www.medscape.com/viewarticle/923801 Cannabidiol (CBD) is having its moment in the sun. A Gallup poll from last August found that 1 in 7 Americans use CBD, that 11% of users are 50 to 64 years of age, and that 8% are at least 65 years of age. Pain relief, anxiety, insomnia, and arthritis are the top reasons for use. Nearly 4 in 10 Americans think CBD oils should be legally available for adults to buy over the counter. Although the 2018 Farm Bill removed hemp (cannabis and cannabis derivatives such as CBD that contain less than 0.3% THC) [...]
Lire la suiteFDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD October 22, 2019 https://www.fda.gov/news-events/press-announcements/fda-ftc-warn-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-teething Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, [...]
Lire la suite