Eszopiclone

'No questions are off limits' during the free Q&A session that is open to the public LOS ANGELES, Dec. 27, 2023 /PRNewswire/ -- Due to the media storm surrounding the recently announced cause of death for late actor Matthew Perry and his reported use of ketamine at the time of his death, leading mental health treatment center Ketamine Clinics Los Angeles (KCLA) announces a free, first-of-its-kind webinar that is open to the public Friday, January 5, 2024 at 1:00 pm PST. Hosted by KCLA Co-founders Dr. Steven L. Mandel and Sam Mandel, the webinar will address the facts and myths about ketamine, distinguishing between the therapeutic uses for mental health and illicit uses of the FDA-approved medication. The two experts will also clarify details reported about Matthew Perry's death and ketamine. Ketamine Clinics Los Angeles wishes to specify the company is speaking about Mr. Perry with no insider knowledge of his ketamine treatments or his personal life. Continue Reading Dr. Steven L. Mandel and Sam Mandel "First and foremost, our reaction to the initial news of Mr. Perry's passing was sadness. Mr. Perry shared publicly regarding his mental health struggles, and we send our deepest condolences to his family and friends," said CEO Sam Mandel. "Regarding the news of the toxicology report, we find it very frustrating and misleading that the spin doctors and media bias against ketamine have twisted this sad loss into another opportunity for ketamine bashing. Not only did Mr. Perry self-administer a sufficient dose to produce general anesthesia, more than ten times the amount given for depression, but he did so in combination with buprenorphine (an opioid) and a benzodiazepine (a sedative) while alone in a hot tub, and lost consciousness and drowned." Ketamine Clinics Los Angeles has pioneered an innovative mental health treatment known as Ketamine Infusion Therapy since 2014, and the Mandels are globally recognized as leading experts in the field. "When used responsibly as a therapeutic agent, ketamine is among the safest, most effective, fastest-acting mental health treatments available today," said Dr. Steven L. Mandel, a board-certified anesthesiologist. "This is not anecdotal. More than 200 clinical studies on ketamine for depression have been completed at leading scientific institutions, proving the safety and efficacy of ketamine for mental health. Dozens of them are peer-reviewed. Ketamine has also been proven as more effective than electroconvulsive therapy (ECT) and quetiapine in head-to-head studies." Ketamine Clinics Los Angeles (KCLA) provides hospital-grade monitoring of electrogram (ECG), blood pressure, pulse rate, oxygen saturation, and respiratory rate during ketamine infusion treatments. The company's clinical staff are all trained in basic life support (BLS), advanced cardiac life support (ACLS), and moderate sedation by the American Society of Anesthesiologists (ASA). KCLA is accredited by Quad A, the gold standard in outpatient facility certification. Every KCLA patient receives treatment in a private room where they are closely monitored under direct observation for safety and comfort by KCLA's care team of an anesthesiologist, psychiatrists, psychiatric mental health nurse practitioners (PMHNP), and registered nurses (RN). KCLA maintains all of the necessary supplies and equipment for emergencies. After more than 30,000 infusions provided over the last decade, none of their patients have needed it. Despite most patients arriving to the clinic with a "treatment-resistant" diagnosis, 83% benefit. "The breakthrough treatments we provide represent a significant step forward in the field of psychedelic medicine and the broader field of mental health care," said Sam Mandel. "Our mission is not only to provide meaningful, lasting relief to our patients but to create a paradigm shift in mental health care throughout the United States and the rest of the world. Ketamine Infusion Therapy is paving the way for other innovative modalities as the best option available today for most patients suffering from depression, PTSD, anxiety, and suicidal thinking." It is KCLA's hope that the webinar and Q&A session will help educate and dispel fears and myths surrounding ketamine therapy. "Two world-renowned experts will answer any and all of your questions about ketamine therapy. Nothing is off-limits," Dr. Steven L. Mandel said. To register for KCLA's free webinar and Q&A on Friday, January 5, 2024, at 1:00 pm PST, please visit About Ketamine Clinics Los Angeles Ketamine Clinics Los Angeles is a pioneering mental health treatment center and leading provider of Ketamine Infusion Therapy. Co-founded by Dr. Steven L. Mandel and CEO Sam Mandel in 2014, KCLA was one of the first ketamine clinics to open in the United States. KCLA is the first and only ketamine clinic accredited by Quad A, upholding the gold standard in safety, efficacy, and patient satisfaction. Services include Ketamine Therapy, Psychiatric Medication Management, and Transcranial Magnetic Stimulation (TMS), with plans for further advancements soon. KCLA has contracted with ten of California's largest health insurance plans to expand access to their services. The clinical team at KCLA comprises an exceptional group of highly skilled professionals regarded as leaders in their field. The team includes one anesthesiologist with a master's degree in psychology, psychiatrists, psychiatric mental health nurse practitioners, registered nurses, and administrative staff. All teammates collaborate in KCLA's state-of-the-art, 5,000-square-foot facility in Los Angeles, California. The company has one location at this time but plans for additional sites in the near future. For more information about Ketamine Clinics Los Angeles and the company's pioneering Ketamine Infusion therapy, please visit . Media Contact: Debby Fireman Fireworks [email protected] 610.547.2229 SOURCE Ketamine Clinics Los Angeles

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