Bethanechol Chloride

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

BOSTON & TAIPEI, Taiwan--(BUSINESS WIRE)-- Corium, LLC (“Corium”), a commercial-stage biopharmaceutical company leading the development and commercialization of novel neuroscience therapies, and Lotus Pharmaceutical (1795:TT; “Lotus”), a multinational pharmaceutical company, announced that the companies have entered into an exclusive Collaboration and License Agreement for ADLARITY® (donepezil transdermal system), an innovative Alzheimer’s dementia treatment, in ten markets across Asia. ADLARITY® is approved in the U.S. by the U.S. Food and Drug Administration as the first and only once-weekly patch for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type. The transdermal system not only offers continuous and sustained release of donepezil through the skin using proprietary CorplexTM technology, but it also bypasses the gastrointestinal tract, enabling a favorable overall gastrointestinal side effect profile. Donepezil, the active ingredient in the oral medication Aricept®, is the leading symptomatic treatment globally for Alzheimer's dementia within the acetylcholinesterase class of therapies. The companies expect to regulatory approval in some Asian markets later this year. "We are thrilled to be collaborating with the team at Lotus, who share our excitement about ADLARITY as a novel way to deliver donepezil,” said Perry Sternberg, President & Chief Executive Officer of Corium. “This partnership represents an important milestone for Corium in establishing ADLARITY® as a global brand and helps further our mission to create and deliver novel therapies that provide clinicians with important treatment options for patients, their families, and their caregivers." “Today’s announcement highlights our drive and focus on innovation to address unmet medical needs across Asia, and validates our strong pipeline of opportunities,” said Petar Vazharov, Chief Executive Officer of Lotus. “With ADLARITY®, we aim to provide a differentiated level of care that can significantly improve the lives of Alzheimer’s patients in our markets. This product is a strategic fit to our portfolio, affirming our strong capability and presence in CNS." Under the terms of the agreement, Lotus will have exclusive rights to commercialize ADLARITY® in the applicable territory and will be responsible for the regulatory approval process. The territory includes Taiwan, South Korea, Hong Kong, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Corium is responsible for supplying finished product to Lotus and will receive an upfront payment as well as regulatory and performance-based milestone payments based on net sales of the product. According to IQVIA data, the market size of donepezil in the 10 markets in the territory is USD 185 Million. By 2030, the number of patients with Alzheimer's dementia in these markets is expected to increase from 3 million in 2015 to 5.5 million1. 1 Alzheimer's disease international (2014). Dementia in the Asia Pacific Region. 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: Skin application-site reactions have occurred with ADLARITY. 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, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. Cardiovascular conditions: Cholinesterase inhibitors, including 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: Donepezil has been shown to produce diarrhea, nausea, and vomiting. Although in most cases these effects have been transient, some cases lasted 1 to 3 weeks. Patients should be observed closely during initiation and titration of ADLARITY. Peptic ulcer disease and gastrointestinal bleeding: Cholinesterase inhibitors, including ADLARITY, may increase gastric acid secretion. Patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of donepezil tablets in a dose of 5 mg/day to 10 mg/day have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Genitourinary conditions: Although not observed in clinical trials of ADLARITY, cholinomimetics, including ADLARITY, may cause bladder outflow obstruction. Seizures: Cholinomimetics, including ADLARITY, are believed to have some potential to cause generalized convulsions; however, seizure activity may also be a manifestation of Alzheimer’s disease. Pulmonary conditions: Cholinesterase inhibitors, including ADLARITY, should be prescribed with caution to patients with a history of asthma or obstructive pulmonary disease. Adverse reactions The most common side effects (>3%) of ADLARITY 10 mg/day TDS 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 ADLARITY, 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 Lotus Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with global presence, focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. The Company has a recognized best-in-class R&D and manufacturing platform in Asia and has established partnerships in nearly every global market including the U.S., Europe, Japan, China, and Brazil. Lotus runs over 100 strategically selected pharmaceutical projects in development and registrations across Asia and the US, with over 250 commercial products. The Company invests in diversified best portfolio consisting of high-barrier oncology, complex generics as well as 505(b)2 and NCE via internal R&D investment and licensing-in partnership, and also strengthens its portfolio competitiveness by adding biosimilar products with support from strategic partners. Its industry-leading infrastructure certified by most of the advanced regulatory authorities around the world, including US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. About Corium Corium, LLC, is a commercial-stage biopharmaceutical company that is leading the development and commercialization of novel neuroscience therapies that provide clinicians with important treatment options for patients, their families, and their caregivers. Corium is commercializing two U.S. FDA approved products, ADLARITY® and AZSTARYS®. For further information, please visit . Lotus Cautionary Note on Forward-Looking Statements Except for historical information contained herein, the matters set forth in this document are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are not based on historical facts but rather on management’s expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities. Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or achievements or other future events constitute forward-looking statements. Wherever possible, words such as “anticipate”, “believe”, “expect”, “may”, “could”, “will”, “potential”, “intend”, “estimate”, “should”, “plan”, “predict”, or the negative or other variations of statements reflect management’s current beliefs and assumptions and are based on the information currently available to our management. Investors are cautioned not to place undue reliance on these forward-looking statements, which are made as of the date of this document, and we assume no obligation to update or revise any forward-looking statements. View source version on businesswire.com: Contacts Lotus Contacts Investor and Media Relations Susan Liao, Head of Investor Relations +886 2 2700 5908 investor@lotuspharm.com Wen Peng, PR Senior Manager +886 2 2700 5908 investor@lotuspharm.com Corium Contacts H/Advisors Abernathy Emma Prenn-Vasilakis 917-763-6685 emma.prenn-vasilakis@h-advisors.global Source: Corium, LLC View this news release online at: