Succinylcholine Chloride

The Second Oral Therapy Approved This Decade, ZUNVEYL’s Dual MOA Was Designed to Eliminate Drug Absorption in the Gastrointestinal (GI) Tract, Potentially Addressing Certain Tolerability Issues with Leading Alzheimer’s Disease (AD) Medications, Combined with a Long-Term Efficacy Profile ZUNVEYL’s Innovative Approach Targets AD Symptoms Directly, Designed to Provide Patients with Significant Benefits to Cognitive and Global Function and the Ability to Perform Daily Living Activities Alzheimer’s Disease, the Most Common Form of Dementia, Affects Nearly 7 Million People in the United States, including 70% of All Nursing Home Residents and is the Leading Cause of Nursing Home Admissions and Deaths VANCOUVER, Canada & DALLAS. TX, USA I July 29, 2024 I Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF)(Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, announces that the U.S. Food and Drug Administration (FDA) has granted approval for ZUNVEYL® (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer’s disease. Alzheimer’s disease (AD) is a progressive brain disorder that slowly destroys memory, thinking skills, and eventually the ability to do simple tasks, like carry on a conversation.AD is the most common form of dementia affecting nearly 7 million people, and is the leading cause of nursing home admissions and deaths, with 70% of all nursing home residents suffering with AD. A novel oral therapy, ZUNVEYL has a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentiallyaddressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine. Tolerability affects therapy adherence, with data showing that 55% of AD patients discontinue their medication after one year, mainly due to GI side effects and insomnia. Medication discontinuation can cause risk to patients themselves, and dissatisfaction and burden among nursing home staff, physicians, and caregivers. ZUNVEYL, a prodrug of AD treatment galantamine and an acetylcholinesterase inhibitor (AChEI), is postulated to exert its therapeutic effect by preventing the breakdown of acetylcholine, the important brain neurotransmitter involved in memory, motivation, and attention functions. It is also an allosteric potentiator of α-7 nicotinic acetylcholine and α4β2 receptors. This action facilitates the release of acetylcholine from the presynaptic neurons, giving clinical significance to its dual mode of action. ZUNVEYL targets AD symptoms, to provide patients with long-lasting benefits to cognitive and global function and the ability to perform daily activities that are impaired by AD. Galantamine, FDA-approved since 2001, has extensive and positive data related to long-term outcomes, demonstrating activity among multiple brain receptors, anti-inflammatory effects, and is associated with improved memory, attention, and a significantly lower risk of death. It also has the strongest effect on cognitive decline in the AChEI class of medications and demonstrated significant risk reduction of developing severe dementia. Due to its prodrug properties, ZUNVEYL is effectively converted into the active moiety of galantamine after it passes through the GI tract, therefore achieving the same therapeutic effects of galantamine. It was also uniquely designedto eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues and has a CNS safety profile that includes no incidence of insomnia. Information about ZUNVEYL’s pivotal clinical studies are included further in this press release, and in the ZUNVEYL prescribing information. “I am very excited about the approval of ZUNVEYL, which we believe offers better tolerability for patients with Alzheimer’s disease. We have always believed in the efficacy of galantamine but have been limited in its use due to tolerability issues. To now have an agent with the efficacy of galantamine, but that also offers the hope of better tolerability, will provide physicians a great option to treat patients,” said Elaine Peskind, MD, the Friends of Alzheimer’s Research Professor of Psychiatry at the University of Washington School of Medicine. “This advancement marks a meaningful step forward in improving the quality of life for those living with Alzheimer’s and their families. As a geriatric psychiatrist specializing in Alzheimer’s disease, I am eager to incorporate this new treatment into our practice and see the positive difference it will make.” “The approval of ZUNVEYL is a pivotal moment in the fight against Alzheimer’s disease as it is only the second oral AD treatment to be approved in more than a decade. ZUNVEYL was designed to addresses a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes,” stated Alpha Cognition Chief Executive Officer Michael McFadden. “We are delighted, as this represents a major breakthrough in Alzheimer’s treatment, providing hope to millions of patients, families, and caregivers affected by this devastating disease.” About the Pivotal ZUNVEYL Clinical Studies ZUNVEYL’s approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of ZUNVEYL compared to galantamine immediate-release tablets and galantamine extended-release capsules. Importantly, there were minimal adverse events reported in these trials. Availability ZUNVEYL will be available by prescription in pharmacies nationwide in Q1 2025. Alpha Cognition is committed to ensuring broad access to this innovative treatment and will work closely with healthcare providers, insurers, and patient advocacy groups to support its distribution. “We are excited to launch ZUNVEYL and bring this much-needed treatment option to patients suffering from Alzheimer’s disease,” said Lauren D’Angelo, Alpha Cognition’s Chief Operating Officer. “Over the coming months, our team will work diligently to prepare for this launch, ensuring that healthcare providers have the information and patients have the resources and support they need. ZUNVEYL offers dual-action benefits with the established efficacy of galantamine and no insomnia. It was uniquely designed to bypass the gut with the potential of minimizing GI side effects. We believe that ZUNVEYL’s unique combination of these attributes will make a meaningful difference in the lives of those affected by this debilitating disease. We look forward to collaborating with our partners to ensure a successful rollout and broad accessibility.” About Alpha Cognition Inc. Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options. ZUNVEYL, previously ALPHA-1062, is a novel patented oral Alzheimer’s disease therapy with a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine. As a new generation acetylcholinesterase inhibitor, it was developed to demonstrate a potentially improved GI side effect profile and has a CNS safety profile that includes no incidence of insomnia. While precise mechanism of action is not known, it is believed that ZUNVEYL works through two distinct pathways to enhance neurotransmitter activity and protect neuronal health, leading to improved cognitive and functional outcomes. Separately, ZUNVEYL is also being developed in combination with memantine to treat moderate-to-severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. For more information about ZUNVEYL, please visit www.zunveyl.com or contact info@alphacognition.com and connect with us on Twitter and LinkedIn . INDICATION ZUNVEYL (benzgalantamine) is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION INDICATION ZUNVEYL® (benzgalantamine) is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION Contraindications ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or any inactive ingredients in ZUNVEYL. Warnings and Precautions Adverse Reactions The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Drug Interactions Cholinesterase inhibitors, including galantamine, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information . SOURCE: Alpha Cognition

ADLARITY is FDA approved for patients with Alzheimer's Dementia Data reinforce favorable skin tolerability and adhesion of first ever once-weekly transdermal system offering continuous delivery of Alzheimer's dementia drug donepezil BOSTON, Sept. 12, 2023 /PRNewswire/ -- Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel neuroscience therapies, announced today the publication of data reinforcing that ADLARITY (donepezil transdermal system) demonstrated favorable skin tolerability and adhesion in a placebo-controlled trial with healthy volunteers. ADLARITY, developed by Corium, is the first and only U.S. FDA approved once-weekly, donepezil transdermal system for patients with mild, moderate and severe dementia of the Alzheimer's type. The data appear in the October-December 2023 issue of the peer-reviewed Alzheimer's Disease and Associated Disorders journal. Continue Reading ADLARITY continuously delivers consistent doses of donepezil through the skin, enabling a generally favorable overall gastrointestinal (GI) side effect profile. Donepezil, an acetylcholinesterase inhibitor and the active ingredient in the oral medication Aricept®, is the most prescribed Alzheimer's dementia medication in the United States. ADLARITY (donepezil transdermal system) demonstrated favorable skin tolerability and adhesion in a placebo-controlled trial with healthy volunteers. Tweet this In the double-blind Phase 1 study (NCT03397862), 256 healthy adults received ADLARITY on one side of their back and a placebo patch on the other side. For three weeks, the investigators placed the patches once weekly on the same location—a condition in the study exaggerating real world use by placing the patches in the same place for three weeks successively. In contrast, during routine patient use, ADLARITY's instructions for use advise patients not to place the patch in the same location for at least two weeks (14 days) after removal from that location. After three weeks, the tested ADLARITY patches caused none-to-minimal skin irritation in most subjects. "These important data show that the once-weekly ADLARITY skin patch had good adhesion and overall mild to no skin irritation despite the exaggerated conditions used during testing," said lead author Marwan N. Sabbagh, MD, Professor of Neurology. "The results grow our understanding of ADLARITY's safety profile and provide additional information that should be helpful to clinicians when considering the only weekly skin patch formulation of donepezil for their Alzheimer's patients." "The skin irritation results showed a trend of better skin tolerability in study participants aged 65 or greater compared to those under 65, which is clinically relevant for the indicated patient population," said Charles Oh, MD, Chief Medical Officer of Corium. "ADLARITY is an example of the value and commitment Corium brings to developing treatment options that address unmet needs of people with neurological conditions." Study examines skin irritation, sensitization, and adherence Investigators measured any skin irritation at study days eight, 15 and 22 using a combined skin irritation score (CSIS) from the Dermal Response Scale and an Other Effects Scale, as recommended by the FDA. After three weeks, the tested ADLARITY patches caused none-to-minimal skin irritation in most subjects, scoring an average 0.55 points (±0.78) of a possible maximum of 7 points using a calculation of the mean CSIS scores across the three weekly measures. The placebo patches scored 0.19 (±0.35), indicating no skin irritation. Of the 198 participants who completed the study, four had potential sensitization to ADLARITY, and none to the placebo patches. In general, on a weekly basis, the patches had good adhesion and essentially no lift from the skin. During the study 12 patches, seven of 735 ADLARITY and five of 736 placebo, detached. The study did not identify any safety concerns of either a local or systemic nature. Treatment emergent adverse events (TEAEs) occurred in more than 10 percent of the patients including application-site pruritis (40.2 percent), headache (18.4 percent), nausea (18.0 percent), abnormal dreams (18.0 percent), muscle spasms (16.8 percent), and insomnia (10.2 percent). Of the 256 participants, 11 participants (4.3 percent) discontinued the study because of TEAEs. One participant discontinued because of application-site reactions [discharge, erythema (red skin), and edema (swelling)] and 10 discontinued because of increased blood pressure (>140 mmHg systolic) considered mild in severity. Physicians interested in receiving more information or resources can request field representative support via . Corium also is supporting patient access to ADLARITY under CoriumCares™, a patient access and support program offering information about access and copay assistance for eligible commercially-insured patients. More information is available at or (800) 433-4893. Marwan N. Sabbagh, MD, Philip Mathew, PhD, and Alan Blau, PhD. A Randomized Double-blind Study to Assess the Skin Irritation and Sensitization Potential of a Once-weekly Donepezil Transdermal Delivery System in Healthy Volunteers. Alzheimer Disease & Associated Disorders ():10.1097/WAD.0000000000000587, September 11, 2023. | DOI: 10.1097/WAD.0000000000000578. Available at . About Alzheimer's Disease Alzheimer's disease is a progressive and irreversible brain disorder. It involves changes in brain tissue including abnormal buildup of proteins as well as loss of neuron function. The resulting damage leads to the loss of remembering, reasoning, and thinking abilities. Dementia ranges in severity from mild, when it is just beginning to affect a person's functioning, to moderate, to severe, when the person must depend on others for the basic activities of day-to-day life. Patients with Alzheimer's disease also develop changing to their swallowing during early to mid-stage disease that can progress to dysphagia, or swallowing impairment, in later stages. Dysphagia increases their risk of dehydration, dehydration, or aspiration, which frequently leads to aspiration pneumonia, a common cause of death among these patients. The related behavioral changes also include the loss of independence in activities of daily living and self-care. An estimated 6.5 million Americans older than 65 were living with Alzheimer's disease in 2022, with a possible rise to 14 million by 2060. Globally, more than 55 million people have dementia, and Alzheimer's disease may account for 60 to 70 percent of patients, according to the World Health Organization. The U.S. Centers for Disease Control and Prevention estimates that in 2021 more than 11 million Americans provided an estimated 16 billion hours of unpaid care for patients with Alzheimer's disease. Indication and Important Safety Information for ADLARITY (donepezil transdermal system) INDICATION ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS ADLARITY is contraindicated in patients with known hypersensitivity to donepezil or to piperidine derivatives or with a history of allergic contact dermatitis with use of ADLARITY. WARNINGS AND PRECAUTIONS Application site skin reactions: ADLARITY may cause skin application-site reactions. These reactions are not necessarily indicative of sensitization; however, allergic contact dermatitis may occur and should be suspected if application-site reactions spread beyond the size of the transdermal system, there is evidence of a more intense local reaction, and symptoms do not significantly improve within 48 hours of transdermal system removal. Anesthesia: ADLARITY is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. Cardiovascular conditions: ADLARITY may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil. Nausea and vomiting: ADLARITY may cause diarrhea, nausea, and vomiting. Although in most cases these effects have been transient, some cases lasted 1 to 3 weeks. Patients should be monitored closely during initiation and titration of ADLARITY. Peptic ulcer disease and gastrointestinal bleeding: ADLARITY may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Genitourinary conditions: Although not observed in clinical trials of ADLARITY, bladder outflow obstruction may occur. Seizures: ADLARITY is believed to have some potential to cause generalized convulsions; however, seizure activity may also be a manifestation of Alzheimer's disease. Pulmonary conditions: ADLARITY should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. ADVERSE REACTIONS The most common side effects of ADLARITY (>3%) were headache (15%), application site pruritus (9%), muscle spasms (9%), insomnia (7%), abdominal pain (6%), application site dermatitis (6%), constipation (6%), diarrhea (4%), application site pain (4%), dizziness (4%), abnormal dreams (4%) and skin laceration (4%). DRUG INTERACTIONS Cholinesterase inhibitors, including donepezil, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol. For additional safety information, click here for the Prescribing Information and Patient Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. About Corium Corium, LLC, is a biopharmaceutical company that is leading the development and commercialization of neuroscience therapies that provide physicians with innovative treatment options for patients, their families, and their caregivers. Corium is commercializing two U.S. FDA approved products, ADLARITY and AZSTARYS, in the U.S., and has licensed each for development and commercialization in certain territories outside the U.S. For further information, please visit . Contact: Corium, LLC Gartman PR [email protected] 202-413-4226 SOURCE Corium, LLC