Zopiclone

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

DUBLIN--( BUSINESS WIRE )--The "Sleep Disorder Treatment Drugs Markets in China" report has been added to ResearchAndMarkets.com's offering. China's demand for Sleep Disorder Treatment Drugs has grown at a fast pace in the past decade. In the next decade, both production and demand will continue to grow. The Chinese economy maintains a high speed growth which has been stimulated by the consecutive increases of industrial output, import & export, consumer consumption and capital investment for over two decades. This new study examines China's economic trends, investment environment, industry development, supply and demand, industry capacity, industry structure, marketing channels and major industry participants. Historical data (2012, 2017 and 2022) and long-term forecasts through 2027 and 2032 are presented. Major producers in China are profiled. The primary and secondary research is done in China in order to access up-to-date government regulations, market information and industry data. Data were collected from the Chinese government publications, Chinese language newspapers and magazines, industry associations, local governments' industry bureaus, industry publications, and our in-house databases. Interviews are conducted with Chinese industry experts, university professors, and producers in China. Economic models and quantitative methods are applied in this report to project market demand and industry trends. Metric system is used and values are presented in either Yuan (RMB, current price) and/or US dollars. Our market research reports provide hard-to-find market data and analyses. Today, China has the largest market in the world. Tremendous fast-growing markets for imports and business opportunities for companies around the world. If you want to expand your business or sell your products in China, our research reports provide the insights and projections into Chinese markets necessary for you to do so. Key Topics Covered: I. INTRODUCTION Report Scope and Methodology Executive Summary II. BUSINESS ENVIRONMENT Economic Outlook Key Economic Indicators Industrial Output Population and Labor Foreign Investment Foreign Trade Financial and Tax Regulations Banking System and Regulations Foreign Exchange Taxes, Tariff and Custom Duties III. SLEEP DISORDER TREATMENT DRUGS INDUSTRY ASSESSMENTS Sleep Disorder Treatment Drugs Industry Structure Market Size Market Growth Driver Sleep Disorder Treatment Drugs Sales Volume Major Producer Facility Locations and Sales Volume Market Share of Key Producers Labor Cost Potential Entrants Major Distributors Major Foreign Investments Technology Development IV. SLEEP DISORDER TREATMENT DRUGS PRODUCTION AND DEMAND Overview Sales Volume of Sleep Disorder Treatment Drugs by Region Sleep Disorder Treatment Drugs Sales Volume Western Sleep Disorder Treatment Drugs Sales Volume Barbiturates Phenobarbital Secobarbital Amobarbital Benzodiazepines Midazolam Estazolam Triazolam Others Non-benzodiazepines Zolpidem Zopiclone Zaleplon Others Chinese Traditional Sleep Disorder Treatment Drugs Sales Volume Acanthopanacis Senticosi Gastrodin Chinese Patent Medicines Sleep Disorder Treatment Drugs Imports and Exports Pricing Trends V. SLEEP DISORDER TREATMENT DRUGS MARKET OUTLOOK Sleep Disorder Treatment Drugs Markets Outlook Government Regulations Health Care Insurance Industry Overview Consumer Spending Trends Northeast North Southeast Central Southwest Northwest Demographic Trends Health Care Industry Trends Hospitals and Hospital Beds VI. MARKETING STRATEGIES China Market Entry Overview China's Distribution System Sleep Disorder Treatment Drugs Distribution Channels Transportation and Freight Infrastructure Communications China's Market Entry Export to China Indirect export Direct Export License and Contract Manufacture Assembling in China Contract Manufacturing Trade Permit Investment Equity Joint Venture Contractual Joint Venture Wholly Foreign-Owned Enterprise VII. SLEEP DISORDER TREATMENT DRUGS PRODUCER DIRECTORY Sleep Disorder Treatment Drugs Producer Profiles and Directory A selection of companies mentioned in this report includes Wusuli River Pharmaceutical Group Wandashan Pharmaceutical Factory For more information about this report visit https://www.researchandmarkets.com/r/irmoip About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.