Eszopiclone

RADNOR, Pa., April 4, 2023 /PRNewswire/ -- Yesterday, a Citizen Petition (CP) was filed on behalf of Idorsia Pharmaceuticals (SIX: IDIA), urging the Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data. The CP to de-schedule the DORA class outlines scientific and medical evidence demonstrating that the DORA class has a negligible abuse pro potential for abuse, lacks non-medical use in the community, lacks physical and psychological dependence, and therefore, should not be a scheduled class under the Controlled Substances Act.1 Chronic insomnia is a sleep disorder when a person has trouble falling or staying asleep. Insomnia impacts approximately 25 million American adults.2 Among the most commonly prescribed medicines that are approved to treat insomnia are benzodiazepines and Z-drugs (including zopiclone, eszopiclone, zaleplon and zolpidem).3 These drugs are only recommended for short-term use with frequent re-evaluation and due to the risk of dependance and misuse and abuse, are scheduled as Schedule IV under the Controlled Substances Act.4 The Schedule IV classification of the DORA class puts them in the same classification as benzodiazepines and Z-drugs; however, the DORA class works differently, blocking signals in the brain that stimulate wakefulness addressing chronic insomnia without creating dependence and with a negligible potential of abuse. 1 "Given the rising cases of substance abuse disorder with certain prescription medications in the United States, I'm pleased to see data from the DORA class, which shows the negligible abuse potential of DORAs when treating insomnia," said Vaughn McCall, MD, Professor and Case Distinguished Chair of the Department of Psychiatry and Health Behavior at Augusta University. "I am hopeful that the DEA will consider de-scheduling the DORA class as it is critical in preventing the overuse of other medications, which may be abused or misused, to treat insomnia." The CP requests that the DEA Administrator initiate a rulemaking proceeding to remove the DORA class medications from scheduling under the Controlled Substances Act (CSA) based on the following three points: Eight years of post-marketing surveillance data suggests that the DORA class has an insignificant risk of abuse pro potential for abuse, lack of non-medical use in the community; and similar lack of physical or psychological dependence1. Based on major federal surveillance systems including FDA's Adverse Events Reporting System (FAERS) the rates of abuse and dependence-related reports, serious adverse events (AEs), and AEs requiring hospitalization associated with the DORA class are extremely low in incidence and substantially lower than rates for Schedule IV benzodiazepines and related drugs, including those sometimes referred to as "Z-drugs" (namely zopiclone, eszopiclone, zaleplon and zolpidem)1. A re-analysis of the Eight Factors of the Controlled Substances Act (a required step in the scheduling process) supports removal of the DORA class from scheduling under the CSA1. "Idorsia is asking the DEA to de-schedule the DORA class as part of our continued commitment to treating insomnia." said Jean-Paul Clozel, MD, Chief Executive Officer of Idorsia. "As there is significantly more data and evidence on the DORA class today than when these drugs were first approved in 2014, we believe that the DEA should reconsider its decision to schedule these drugs, considering they have negligible abuse profiles and potential for abuse. Access to the DORA class of medicines for insomnia should not be limited by the constraints put in place to manage and restrict the use of scheduled drugs or controlled substances." DORAs block the activity of orexin, they "turn down" overactive wakefulness pathways, in contrast to insomnia treatments which act via general CNS sedation. DORAs specifically target the orexin system by competitively binding and antagonizing both orexin receptors, thereby reversibly blocking the activity of orexin. Blocking orexin receptors reduces the downstream activity of the wake-promoting neurotransmitters that are overactive in insomnia. As a result, orexin receptor antagonism targets the fundamental mechanism of insomnia and does not activate dopamine neurons, thus representing much lower risks of abuse, dependence, and overdose than conventional Schedule IV drugs used to treat insomnia. A Citizen Petition can be filed to ask that a governing agency, like the DEA or US Food and Drug Administration, take or refrain from taking a particular action. Any person may Citizen Petition, and any person may comment on a petition that has been Idorsia cannot predict when or if the DEA will respond to or otherwise take any action concerning the Citizen Petition To view the petition, click here. Notes to the editor About Insomnia According to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5®), insomnia is defined as a combination of difficulty obtaining sufficient sleep and dissatisfaction with sleep combined with a significant negative impact on daytime functioning. Chronic insomnia is defined as difficulty initiating and/or maintaining sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep. Insomnia is a condition of overactive brain activity during sleep, and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. Insomnia is the most common sleep disorder, affecting more than 25 million adults in the US.2 Poor quality or insufficient sleep can affect many aspects of the daily lives of people with trouble sleeping including the ability to concentrate, mood and energy levels.4 In the long-term, insomnia is associated with numerous serious health conditions, such as psychiatric disorders, cardiovascular disease, type 2 diabetes, substance abuse and dementia.7,8,9 References EXHIBIT B (statement of grounds) - Petition to Reschedule QUVIVIQ (daridorexant) REVISED DRAFT 3.25.23 Bhaskar S, Hemavathy D, Prasad S. Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. J Family Med Prim Care. 2016;5(4):780-784. doi:10.4103/2249-4863.201153 Bertisch, S. M., Herzig, S. J., Winkelman, J. W., & Buettner, C. (2014). National use of prescription medications for insomnia: NHANES 1999-2010. Sleep, 37(2), 343–349. Sateia, M. J., Buysse, D., Krystal, A. D., Neubauer, D. N., & Heald, J. L. (2017). 0395 clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: An American Academy of Sleep Medicine Clinical Practice guideline. Sleep, 40(suppl_1). U.S. Department of Health and Human Services. (2023, March 8). Drug overdose death rates. National Institutes of Health. Retrieved March 15, 2023, from Drug Overdose Death Rates | National Institute on Drug Abuse (NIDA) (nih.gov) Ustinov Y, Lichstein KL, Wal GS, Taylor DJ, Riedel BW, Bush AJ. Association between report of insomnia and daytime functioning. Sleep Med. 2010 Jan;11(1):65-8. doi: 10.1016/j.sleep.2009.07.009. Epub 2009 Sep 23. 4. Olfson M, Wall M, Liu SM, Morin CM, Blanco C. Insomnia and Impaired Quality of Life in the United States. J Clin Psychiatry. 2018 Sep 11;79(5):17m12020. doi: 10.4088/JCP.17m12020. 5. Doghramji K. The epidemiology and diagnosis of insomnia. Am J Manag Care. 2006 May;12(8 Suppl): S214-20. PMID: 16686591. 6. de Almondes KM, Costa MV, Malloy-Diniz LF, Diniz BS. Insomnia and risk of dementia in older adults: Systematic review and meta-analysis. J Psychiatr Res. 2016 Jun;77:109-15. doi: 10.1016/j.jpsychires.2016.02.021. Epub 2016 Mar 8. PMID: 27017287. About Idorsia US Idorsia US, an affiliate of Idorsia, is reaching out for more – we have more ideas, we see more opportunities, and we want to help more patients. To achieve this, we will help develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. With commercial operations based outside of Philadelphia, PA, one of densest communities of life sciences talent in the world, we are helping to realize the company's ambition of bringing innovative medicines from bench to bedside. Our goal is to build a commercial footprint that will deliver Idorsia's deep pipeline of products from its R&D engine to the US market – with the potential to change the lives of many patients. About Idorsia Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1'000 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contact US Media Christopher Clark Senior Director, US Head of Communications Idorsia Pharmaceuticals US, 100 Matsonford Road, Radnor, PA 19087 +1 (215) 421 4887 christopher.clark@idorsia.com Global Investors & Media Andrew C. Weiss Senior Vice President, Head of Investor Relations & Corporate Communications Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.relations@idorsia.com media.relations@idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Company Codes: Swiss:IDIA

LEXINGTON, Mass.--(BUSINESS WIRE)-- Cognesy Therapeutics, a recently established company developing a platform for the discovery of neuroplasticity-inducing drugs to treat a wide range of neuropsychiatric disorders, announced appointments of its senior leadership team, the company said today. This press release features multimedia. View the full release here: Thomas C. Wessel, MD, PhD, CEO, Cognesy Therapeutics (Photo: Business Wire) The company seeks to address the worldwide medical need for novel therapeutics to treat central nervous system diseases, such as depression, anxiety, schizophrenia and dementia, as well as acquired brain disorders, such as stroke and traumatic brain injury. Collectively, these conditions affect one in eight people worldwide, and many of these patients are not adequately treated with current drugs. Cognesy’s initial investor is Gordian Ventures, an incubation fund investing in and building global life science companies. A growing body of evidence points to neuroplasticity as a shared neurobiological response underlying the clinical efficacy of different compounds, including ketamine and esketamine as well as various psychedelic agents such as psilocybin, for treating depression, post-traumatic stress disorder, and other conditions. Although these compounds have significant activity and act rapidly, their consciousness-altering, hallucinatory and other side effects present significant challenges to broader clinical use. “Our neuroplasticity-first approach has immense potential to rapidly generate compounds with promise across a broad range of psychiatric and cognitive disorders, stroke and traumatic brain disorders, substance abuse conditions and pain,” commented Tom Wessel, CEO at Cognesy Therapeutics. “Cognesy has established an outstanding team with deep experience in CNS drug discovery and development.” CSO Pete Distefano added: “Our team is building a cutting-edge neuroplasticity drug discovery platform that integrates advanced medicinal chemistry, proprietary screens for neuroplasticity, and in vivo models to assess efficacy and safety of novel compounds. We believe this approach will lead to new insights and important new agents to trigger neuroplasticity in different clinical settings.” The senior leadership team at Cognesy Therapeutics includes: Thomas C. Wessel, MD, PhD, Chief Executive Officer, is a board-certified neurologist with more than 25 years of drug development experience, including as medical lead for three CNS products approved in the United States: Razadyne® (galantamine), Lunesta® (eszopiclone) and Ampyra® (dalfampridine). Previously, Dr. Wessel served in research leadership roles at Relmada Therapeutics, Asceneuron, Flex Pharma, Acorda Therapeutics, Sepracor and Janssen Pharmaceuticals. Peter S. DiStefano, PhD, Co-founder and Chief Scientific Officer, who has more than 35 years’ drug discovery and development experience in the pharmaceutical and biotech industries. Dr. DiStefano joined Cognesy from Zebra Biologics, where he was Chief Scientific Officer. Prior to that he served as Senior Vice President of Research and Development at Second Genome, as Chief Scientific Officer, and Senior Vice President of Research and Development at Elixir Pharmaceuticals, Earlier in his career, Dr. DiStefano served in research leadership and research positions in neurology and neurobiology at Millennium Pharmaceuticals, Regeneron and Abbott Laboratories. Danny Talati, PharmD, MBA, Senior Vice President, Corporate Strategy, has spent more than 20 years in the pharmaceutical industry in a variety of roles, including sales, medical and business development. Prior to joining Cognesy, Dr. Talati was Head of Business Development at atai Life Sciences. Previously, he held roles at a number of companies, including ten years at Eli Lilly, primarily in the Neuroscience Medical division. Neuroplasticity is the process by which the brain changes through nerve cell growth, reorganization and communication to alter its function. The process is fundamental to growth, from infancy to adulthood, to learning and memory, and to recovery from brain injury. Neuroplasticity involves changes at the molecular level (e.g., expression of brain growth factors), cellular level (e.g., increases in synapses between neurons), and system levels (e.g., increased synaptic connectivity among brain regions). Cognesy’s platform is focused on the discovery of first-in-class neuroplasticity-inducing drugs with potential to treat multiple neuropsychiatric disorders. The company’s goal is to design compounds with improved therapeutic profiles – enhanced activity without side effect liabilities of existing drugs. The company’s platform integrates advanced medicinal chemistry with screens for neuroplastic activity, including neurite outgrowth and synaptogenesis, as well as assays to determine a compound’s mechanism of action and the pathway in which it acts. These assays are coupled with in vivo disease models as well as predictive models for human hallucinogenic potential. About Gordian Ventures Gordian is a global life science venture fund focused on the incubation of companies with high technical barriers to entry. Gordian’s team is comprised of successful entrepreneurs who focus on being a co-founder to each of the ventures it incubates. Gordian has offices in Lexington, Massachusetts and Shanghai, China. Learn more at . About Cognesy Therapeutics Cognesy Therapeutics is building a best-in-class platform technology to discovery of novel drugs that induce neuroplasticity for the treatment of neuropsychiatric diseases. Learn more at: .