Zolpidem Tartrate

A seasoned pharmaceutical industry executive with over 40 years at the forefront of innovation, including at Synthelabo (acquired by Sanofi-Aventis), Dr. Angel aims to propel MIRA Pharmaceuticals' mission to tackle unmet needs in neurologic and neuropsychiatric disorders MIAMI, March 21, 2024 /PRNewswire/ -- MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on the development of novel treatments for neurologic and neuropsychiatric disorders, proudly announces the appointment of distinguished pharmaceutical executive Dr. Itzchak Angel as its new Chief Scientific Advisor. Dr. Angel brings over 40 years of preclinical, clinical and regulatory acumen to MIRA. He has significantly contributed to the research, development and regulatory approval of groundbreaking medications over his remarkable career. Notably, at Synthelabo (later acquired by Sanofi-Aventis), Dr. Angel played a pivotal role in advancing several drugs, including Litoxetine for depression and Deriglidole for Type-II diabetes, from conception to Investigational New Drug (IND) applications and clinical trials. Additionally, his activities contributed to the development and marketing of Mizollen (mizolastine), Xatral (alfuzosin) and Ambien (zolpidem). Beyond his tenure at Synthelabo, Dr. Angel has made significant advancements in the pharmaceutical industry, including impactful work at several companies, such as Teva, where he was an external consultant in strategic drug development and innovation. He has also founded and served as an officer and director of several pharma start-ups. He was Vice President for Research and Development at D-Pharm Biopharmaceuticals, where he advanced DP-VPA into the human trials for epilepsy and bi-polar disorders (later licensed to Shire Pharmaceuticals) and the chelator DP-b99 for stroke (which advanced to phase-III clinical trials). Dr Angel also served as President and Chief Executive Officer of stem-cell company Accellta; Vice President for Research and Development at Proteologics Ltd and at Galmed Pharmaceuticals (where he advanced Aramchol through an IND to phase-II clinical trials); Head of Discovery and Research and Development Concenter Biopharma (where he advanced Zygosid-50 towards clinical trials) and others. His experience extends through various therapeutic areas and has led to the successful research and development of several drugs, highlighting his vast expertise and ability to bring critical treatments through the regulatory process and ultimately to market. Dr. Angel's extensive background in drug development, from preclinical research through clinical trials and market introduction, positions him well to contribute to MIRA's scientific endeavors. His leadership is expected to accelerate MIRA's research and development pipeline, particularly in advancing its flagship compounds, including the innovative Ketamir-2 for treatment-resistant depression. "We are truly honored to have Dr. Angel on our team," stated Erez Aminov, Chairman & CEO of MIRA. "His distinguished career across the pharmaceutical industry, from start-ups to big pharma, his exceptional scientific skills and his dedication to pharmaceutical innovation will help propel our promising pre-clinical drug candidates forward. His expertise will be invaluable as we move our product candidates towards INDs and through the clinical trial and regulatory approval process and also as we seek to expand our product candidate portfolio." Dr. Angel stated, "I am thrilled to contribute to MIRA's pioneering efforts in addressing the challenges in neurologic and neuropsychiatric disorders. I look forward to applying my experience and insights to help advance MIRA." About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. The Company's novel oral pharmaceutical marijuana, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. MIRA also holds the exclusive U.S., Canadian and Mexican rights for Ketamir-2, a novel, patent pending novel oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation and post-traumatic stress disorder. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Additional information about the Company is available at: . Cautionary Note Regarding Forward-Looking Statements This press release and the statements of the Company's management related thereto contains "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "Aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding Ketamir-2's potential in treating certain mental health conditions. Any forward-looking statements in this press release are based on the Company's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results (including the anticipated benefits Dr. Angel's services to the Company) to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in its registration statement on Form S-1 and other SEC filings, which are on file with the SEC at and the Company's website at . The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. SOURCE MIRA Pharmaceuticals, Inc.

Bedtime drug being developed by Tonix relieved pain by targeting fibromyalgia's characteristic "non-restorative sleep": Potential for FDA Approval in 2025 CHATHAM, NJ / ACCESSWIRE / February 26, 2024 / People who are suffering from fibromyalgia pain are closer to a new option for treatment that targets their characteristically poor sleep quality. Tonix Pharmaceuticals (TNXP) reported positive study results for its sleep-quality targeted therapy in late December. The drug reduced widespread pain in fibromyalgia reported by study volunteers, a sign it could be the first in a new class of painkiller to be approved for use in fibromyalgia. In the latest fibromyalgia phase 3 study, Tonix's product candidate Tonmya®* improved fibromyalgia pain with a highly statistically significant p-value of 0.00005 on the primary endpoint which was the improvement in daily pain relative to placebo. The results also showed favorable tolerability with no unexpected side effects. About 10 million Americans suffer from fibromyalgia and the majority are prescribed a medicine for the characteristic widespread pain. It is known that the brain creates the feeling of pain. Fibromyalgia results when the brain becomes overly sensitive. The fibromyalgia brain sounds the pain alarm in response to sensory experiences that most healthy people ignore. Brain imaging studies have revealed that the fibromyalgia pathology activates the same parts of the brain that pain normally activates in healthy people. Consequently, the pain that fibromyalgia patients experience is real to them. It is unknown how fibromyalgia turns up the volume on brain sensitivity. It is also unknown how good sleep is able to reset the fibromyalgia brain's over-sensitive perception. The experimental medicine targets the characteristic sleep disturbance of fibromyalgia, called "non-restorative sleep." People with fibromyalgia wake up feeling unrefreshed because their sleep fails to provide the restorative properties that healthy people enjoy. While targeting sleep is the novel mechanism of the new drug, it also provides a direct benefit because sleep disturbance is one of the core symptoms of fibromyalgia. In the study, Tonmya improved sleep quality relative to placebo by both the PROMIS sleep disturbance scale p = 0.0000001 and a daily sleep diary p = 0.0007. The role of poor sleep in causing, perpetuating or exacerbating fibromyalgia has been recognized for more than 50 years. In the 1970's, Professor Harvey Moldofsky at the University of Toronto deprived undergraduates of deep sleep and found that most of them developed symptoms of fibromyalgia. Developing drugs to target fibromyalgia's characteristic sleep problem has been challenging. Daily bedtime Ambien® (zolpidem) was studied and did not improve fibromyalgia. Intriguing results were achieved by treating fibromyalgia patients with the sleep drug Xyrem® (sodium oxybate). That drug induces a profoundly deep sleep and is approved for narcolepsy. It is hard to rouse people after taking Xyrem. While the results with Xyrem were scientifically interesting, an advisory committee to the U.S. Food and Drug Administration (FDA) voted against approval for fibromyalgia and the sponsor, Jazz Pharmaceuticals decided not to pursue approval. Because of the risk of diversion for date rape, Xyrem is burdened by a complex risk evaluation and mitigation strategy (REMS) program. This history with Ambien shows that the type of sleep drug and its particular effect on sleep are important in determining whether it will be therapeutic for fibromyalgia. Tonix's new drug candidate Tonmya™ improves sleep quality by blocking four receptors in the brain, each of which plays roles in disturbing sleep. The normal function of these four receptors is to increase alertness, vigilance or wakefulness or to sound the alarm to wake up. Consequently, when they fire during sleep, they can play pathological roles in fibromyalgia. During the time fibromyalgia patients want to sleep, these receptors can disrupt sleep quality. By blocking these receptors during sleep, Tonmya improves the quality of sleep and removes an obstacle to recovery. Tonix's drug, also known as TNX-102 SL, belongs to a new class of medicines for fibromyalgia. Tonmya's active ingredient has a chemical structure with three rings, so it is called a "tricyclic." The Tonix drug is a sublingual tablet to be taken at bedtime, designed to deliver the active ingredient into the brain during sleep and reduce its presence during wakefulness. This is the first program pursuing a drug to improve sleep quality in fibromyalgia since 2009 that is headed to the FDA for a decision on approval. Tonix says it intends to approval by submitting a New Drug Application (NDA) with the FDA in the second half of this year. The company expects a decision from the FDA in 2025. "If and when Tonmya is approved, it will offer a new first line treatment option for fibromyalgia patients," Tonix Chief Executive Officer Seth Lederman, M.D., said. "Ultimately, we believe Tonmya will also be an option for patients who need pain relief but can't tolerate or don't respond to the currently marketed drugs for fibromyalgia. Because Tonmya targets sleep quality, we believe it's a major step forward in both the treatment of fibromyalgia and in understanding the roles of non-restorative sleep in causing or exacerbating fibromyalgia." With the current FDA-approved drugs, fibromyalgia patients face tough choices: take Cymbala® (duloxetine) from Eli Lilly or Savella® (milnacipran) from Abbvie, Inc. and risk insomnia or take Lyrica® (pregabalin) from Pfizer, Inc. and risk increased fatigue. Tonmya demonstrated improved pain, sleep and fatigue in fibromyalgia patients in its confirmatory phase 3 study. New Jersey-based Tonix studied Tonmya in three late-stage, or phase 3, trials that enrolled more than 1,400 subjects with fibromyalgia. Tonix also studied TNX-102 SL in three phase 3, trials that enrolled more than 1,200 subjects with posttraumatic stress disorder (PTSD) which has a different sleep disturbance. Axsome plans to new drug application this quarter for esreboxetine for the management of fibromyalgia. Esreboxetine has a mechanism similar to Cymbalta and Savella but is more specific for norepinephrine reuptake. *Tomya is conditionally accepted by the U.S. Food and Drug Administration (FDA0 as the tradename for TN-102 SL for the management of fibromyalgia. Tonmya is an investigational new medicine and has not been accepted for any indication. Featured photo by Jonathan Borba on Unsplash. Click here for more information on Tonix Pharmaceuticals: Important notice, please read: Certain statements in this document are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the "SEC") in March 2023, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein. Contact Tonix Pharmaceuticals Holding Corp. Jessica Morris (corporate) investor.relations@tonixpharma.com SOURCE: Tonix Pharmaceuticals View the original press release on accesswire.com