Paranoid Schizophrenia

AUCKLAND, New Zealand, Jan. 26, 2023 /PRNewswire/ -- Douglas Pharmaceuticals, a New Zealand Pharmaceutical company focused on specialty generic and repurposed drug development, today announced the formation of a clinical advisory board to support its lead program R-107, an oral extended-release dose of racemic ketamine being developed as add-on or monotherapy for treatment resistant depression (TRD). "We are very excited to bring together a group of world-class experts in the field of psychiatry, to help guide our late-stage development of R-107," said Peter Surman, Chief Scientific Officer. "We believe their deep knowledge in the field, insights and contributions will be instrumental in charting an efficient course through pivotal clinical studies in TRD." The members of the clinical advisory board include: Prof. Paul Glue, MB, ChB (Otago), MD (Bristol), FRCPsych – Dr. Paul Glue is the Hazel Buckland Professor of Psychiatry at the University of Otago, New Zealand and Chair of Douglas' R-107 Trial Steering Committee. He joins in the role of Board Chair with extensive experience in psychiatric research in ketamine, including early development of R-107. His areas of interest include the pharmacology of drug treatments in psychiatry and the investigation of disease mechanisms in neurological and psychiatric disorders. He has published extensively in the fields above, with more than 250 papers and book chapters to his name. Prof. Alan F. Schatzberg, MD – Dr. Alan F. Schatzberg is the Kenneth T. Norris, Jr. Professor of Psychiatry & Behavioural Sciences at Stanford University, US. From 1991-2010, he was the Chair of the Department at Stanford. He is also the Director of the Stanford Mood Disorders Center and Emeritus Editor for Journal of Psychiatric Research. Dr. Schatzberg's current research interests include the biological bases of depressive disorders, glucocorticoid/dopamine interactions in delusional depression and pharmacologic treatment of depressive disorders, with more than 400 publications to date. Dr. Schatzberg has been extensively involved as investigator in several trials in depressive disorders. He was elected the 136th President of the American Psychiatric Association and is a member of the National Academy of Medicine. Prof. Sanjay J. Mathew, MD – Dr. Sanjay J. Mathew is a Professor of Psychiatry and Behavioural Sciences, Vice Chair for Research and Director of Mood and Anxiety Disorders Program at Baylor College of Medicine, Texas, USA. His clinical expertise is in the psychopharmacological management of adult patients with difficult-to-treat depressive and anxiety disorders. He has been the recipient of several grants related to his research in the neurobiology treatment of depressive disorders and authored over 150 manuscripts. Prof. Allan Young, MB, ChB, MPhil, PhD, FRCP (Edin.), FRCPC, FRCPsych – Dr. Allan Young is Professor of Mood Disorders and is the Director of the Centre for Affective Disorders in the Department of Psychological Medicine in the Institute of Psychiatry, Psychology and Neuroscience as well as Head of School and Vice-Dean for Academic Psychiatry at King's College London, UK. Dr. Young is the National Institute for Health Research (NIHR) Mental Health Biomedical Research Centre (BRC) Cluster and Theme lead in the Translational Therapeutics Cluster. He is the clinical academic lead in the Psychological Medicine and Integrated Care Clinical Academic Group in the South London and Maudsley NHS Trust where he is also a Consultant Psychiatrist and the head of the National Affective Disorders Tertiary Clinic. Dr. Young's research interests focus on the cause and treatments for severe psychiatric illnesses, particularly mood disorders. He is ranked as one of the world's leading scientific minds according to the Thomson Reuters Highly Cited Researchers list, ranking among the top 1% most cited for their subject field and year of publication, a mark of exceptional impact. Prof. Wiesław J. Cubała, MD, PhD – Dr. Wiesław J. Cubała is the Head of the Department of Psychiatry at the Medical University of Gdansk, Poland. His research interests focus on the psychopharmacology of mood disorders with a particular interest in ketamine/esketamine/arketamine use in major depression and bipolar disorder as well as clozapine use in treatment-resistant bipolar depression with a focus on suicidality and its rapid-cycling course. Dr. Cubała is engaged in the development of the national treatment guidelines for mood and anxiety disorders. He is also the author of over 160 publications in depressive disorders and was an editorial board member of BJPsych Open and European Neuropsychopharmacology: the journal of the European College of Neuropsychopharmacology in 2021. Dr. Cubała has been extensively involved as investigator in several trials in mood disorders including 14 trials with Rapid-Acting Antidepressants to date. Prof. Colleen Loo, MBBS (Hons), FRANZCP, MD –Dr. Colleen Loo is Professor of Psychiatry at the University of New South Wales, Sydney and Professor and leader of the Neurostimulation and Interventional Psychiatry program at the Black Dog Institute, Sydney, Australia. Her research interests focus on improving treatments for treatment-resistant depression, including electroconvulsive therapy (ECT), Transcranial Magnetic Stimulation (TMS), transcranial Direct Current Stimulation (tDCS) and ketamine. She was president of the International Society for ECT and Neurostimulation from 2018-2020. From 2011, she conducted a series of studies on ketamine treatment of depression, examining different routes of administration, dosing approaches and developing a system for safety monitoring. She has published over 300 peer reviewed papers and contributed to national and international guidelines. For further information, please contact: Stephen Waterman Managing Director PharmaVentures Ltd [email protected] +44-7931144097 About Douglas Pharmaceuticals Douglas Pharmaceuticals is New Zealand's largest privately owned pharmaceutical and healthcare company. It was founded in 1967 by pharmacist Sir Graeme Douglas and today employs over 700 people and exports to over 40 countries around the world. The Douglas mission is to 'Improve Lives' by providing innovative, competitive, and high-quality healthcare solutions. Douglas' core business is producing prescription drugs for areas including oncology, dermatology, the central nervous system, and immunology. Douglas develops, manufactures, and distributes novel and generic products, with a preference for those where there is a strong intellectual property position as well as technical complexity in areas of high unmet need. Furthermore, as of Sep 2022 a state-of-the-art research and development facility has opened in West Auckland, which aims to use world class medical research to find solutions for a range of serious illnesses. The $50MM Douglas Innovation centre is part of the long-established Douglas campus in Auckland. The three story, 4,500sq metre building was 18 months in construction. It employs 100 people and includes laboratory, pilot scale product development suites, commercial manufacturing rooms which can handle highly potent and cytotoxic products, and office space. Manufacturing capabilities include soft gelatine encapsulation, liquids, creams, and modified release oral dosage forms. For more information, please visit: R-107 R-107, an oral extended-release dose of racemic ketamine being developed as add-on or monotherapy for treatment resistant depression (TRD). Phase 2 results demonstrated a significant antidepressant effect within 8 days, dose-dependent sustained mood improvement, with maintenance of response at 3 months, high compliance at-home dosing regimen. R-107's robust safety profile is enabled by a proprietary oral extended-release tablet, which has been formulated with abuse-deterrent features. R-107 has potential for expedited regulatory pathway in the US and EU, with potential market entry as early as 2026 and a strong IP protection in place through to at least 2037 excluding potential extensions. Douglas has also collected positive responses to the R-107 Target Product Profile from Key Opinion Leaders and payers in US & EU. SOURCE Douglas Pharmaceuticals

Improvement in sleep domain scores was statistically significant and observed throughout the twelve-month study BOSTON, Sept. 21, 2022 /PRNewswire/ -- Corium, Inc., a fully integrated biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced publication of a poster, "Serdexmethylphenidate/Dexmethylphenidate Effects on Sleep in Children With Attention-Deficit Hyperactivity Disorder," at the Psych Congress 2022 in New Orleans. The poster presented an analysis of the twelve-month open label safety study in children ages 6-12 using AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), which is indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients six and older. The data showed that the children, after one month of taking AZSTARYS, had statistically significant improvement in their sleep as assessed by the Children's Sleep Habits Questionnaire (CSHQ). The improvement in sleep was sustained through 12 months of treatment with AZSTARYS. Continue Reading AZSTARYS, a central nervous system (CNS) stimulant designated a Schedule II controlled substance, is the first and only medicine for ADHD symptoms containing SDX, the prodrug of d-MPH, along with immediate-release d-MPH. SDX is designed specifically to be pharmacologically inactive until reaching a patient's lower gastrointestinal (GI) tract, where, by design, the prodrug gradually converts to d-MPH throughout the day. This formulation provides control of ADHD symptoms rapidly with the immediate-release d-MPH and for an extended duration with SDX. Once-daily AZSTARYS is available in the U.S. in three SDX/d-MPH dose strengths of 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg. The SDX component of AZSTARYS is designated a Schedule IV controlled substance. After one month of taking AZSTARYS, children with ADHD had statistically significant improvement in their sleep Tweet this "Sleep-related problems are common in children with ADHD, which some stimulant medications can negatively impact. The positive study data reported provide important and relevant information to healthcare professionals considering AZSTARYS," said Greg W. Mattingly, lead author of the poster, associate clinical professor of psychiatry at Washington University School of Medicine, and president elect of the American Professional Society for ADHD and Related Disorders. "These data show how existing sleep problems in children with ADHD improved when treated with AZSTARYS during the study," said Charles Oh, MD, Chief Medical Officer of Corium. "Presenting these AZSTARYS findings at Psych Congress 2022 is another milestone in Corium's ongoing activities to lead in the CNS therapeutic space." About the Open Label Safety Trial This one-year dose-optimized open-label study (NCT03460652) enrolled 282 children aged 6 to 12 years at 19 locations in the U.S. The participants included 70 children who participated within the previous 45 days in a prior double-blind AZSTARYS classroom study (NCT03292952) and 212 new children. After a 30-day screening phase and a three-week dose-optimization phase for new participants, the children received treatment with AZSTARYS for one year. Optimized AZSTARYS doses included 26.1/5.2 milligrams (mg), 39.2/7.8 mg, or 52.3/10.4 mg of SDX/d-MPH daily, which delivered 20-, 30-, and 40-mg molar equivalent doses of total d-MPH HCl. The Children's Sleep Habits Questionnaire (CSHQ) was a pre-specified secondary endpoint that evaluated sleep parameters. The sleep assessment included data from 238 children. After one month of AZSTARYS treatment in the open-label classroom study, the children's total average sleep disturbance score on the CSHQ significantly decreased, indicating overall improvements in their sleep behavior. Specifically, their scores decreased from 53.4 (±5.9 standard deviation [SD]) at the study start to 50.5 (±5.4) at one month, a least-squares mean change from baseline of −2.9 points (95% CI: −3.5 to −2.4; P < .0001). Moreover, their total mean CSHQ scores remained in a range of 48.9 to 50.1 points for up to 12 months, indicating sustained overall sleep improvement from baseline. About ADHD Attention-deficit hyperactivity disorder (ADHD) is a common neurodevelopment disorder marked by an ongoing pattern of inability to pay attention or hyperactivity with impulsive behaviors or both, which interferes with functioning or development. ADHD usually is diagnosed during childhood but often continues into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active. In the United States, an estimated 6.1 million children have received an ADHD diagnosis, including 2.4 million aged 6 to 11 years. Indication and Important Safety Information for AZSTARYS (serdexmethylphenidate and dexmethylphenidate) INDICATION AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Known hypersensitivity to serdexmethylphenidate, methylphenidate, or other product components. Bronchospasm, rash, and pruritus have occurred with AZSTARYS. Hypersensitivity reactions such as angioedema and anaphylactic reactions have occurred with other methylphenidate products. Concomitant treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days, because of the risk of hypertensive crisis. WARNINGS AND PRECAUTIONS Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported at recommended doses. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, coronary artery disease, or other serious heart problems. CNS stimulants cause an increase in blood pressure and heart rate. Monitor all patients for hypertension and tachycardia. Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a history of psychotic illness or mania. Discontinue if symptoms occur. Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed. CNS stimulants, including AZSTARYS, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Carefully observe patients during treatment for digital changes. Further evaluation may be required, including referral. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor height and weight at appropriate intervals in pediatric patients. Treatment may need to be interrupted in children not growing or gaining weight as expected. ADVERSE REACTIONS Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased. DRUG INTERACTIONS Adjust dosage of antihypertensive drug as needed. Monitor blood pressure. Avoid use of AZSTARYS on the day of surgery if halogenated anesthetics will be used. For additional safety information, click here for Prescribing Information and Medication Guide, including BOXED WARNING. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. About Corium Corium, Inc., is a fully integrated biopharmaceutical company that is leading the development and commercialization of CNS therapies that provide physicians with innovative treatment options for patients, their families, and their caregivers. Corium is commercializing two FDA approved products, ADLARITY and AZSTARYS. For further information, please visit . About Gurnet Point Capital Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, GPC is able to deliver differentiated results for its investors and partners. For more, go to . Reference Kollins SH, Braeckman R, Guenther S, et al. A Randomized, Controlled Laboratory Classroom Study of Serdexmethylphenidate and d-Methylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021;31(9):597-609. doi:10.1089/cap.2021.0077 Contact: Corium, Inc. [email protected] or 202-413-4226 SOURCE Corium, Inc.

Debut of sleep effects, disorder severity reduction and real-world analysis data on AZSTARYS, first and only ADHD medication with novel prodrug of dexmethylphenidate Report of comparison with oral donepezil and skin effects data on ADLARITY, first and only once-weekly patch for patients with mild, moderate, or severe dementia of the Alzheimer's type BOSTON, Sept. 13, 2022 /PRNewswire/ -- Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announces the debut of positive data on September 18, 2022, at the upcoming Psych Congress 2022 in New Orleans about its two FDA-approved medicines, AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) for patients six and older with ADHD, and ADLARITY (donepezil transdermal system) for patients with mild, moderate, or severe dementia of the Alzheimer's type. The five poster presentations affirm Corium's progress in developing transformative medicines that improve the health of patients with CNS disorders. Among the three posters reporting new AZSTARYS findings are the debut of analysis of the medicine's effects on children's sleep, disorder severity reduction, and real-world usage. The two ADLARITY posters will report bioequivalence and safety comparisons with oral donepezil and new skin tolerability results of the transdermal formulation. "The positive data from Corium that will be featured at Psych Congress 2022 deliver meaningful knowledge about our two CNS treatments, AZSTARYS for ADHD and ADLARITY for dementia due to Alzheimer's disease," said Charles Oh, M.D., Chief Medical Officer of Corium. "Our broad participation at Psych Congress is also a significant milestone highlighting Corium's ongoing commitment and leadership in the CNS therapeutic space." Corium's Psych Congress 2022 posters will be presented on Sunday, September 18, and Monday, September 19, from 1:30 to 3:00 pm CDT (2:30 to 4:00 pm EDT) in Hall D of the New Orleans Convention Center: About AZSTARYS AZSTARYS, approved for patients aged 6 years and older, is the first and only once daily treatment for ADHD symptoms containing SDX, the prodrug of d-MPH. SDX is designed specifically to be pharmacologically inactive until reaching a patient's lower gastrointestinal (GI) tract, where, by design, the prodrug gradually converts to d-MPH throughout the day. This formulation provides control of ADHD symptoms both rapidly with the immediate-release d-MPH and for an extended duration with SDX. Once-daily AZSTARYS is available in the U.S. in three SDX/d-MPH dose strengths of 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg. About ADLARITY ADLARITY is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of the adverse GI side effects and fluctuations in drug concentrations associated with oral donepezil. Donepezil is the most prescribed medication in a class of Alzheimer's drugs known as acetylcholinesterase inhibitors and is the active ingredient in the oral medication Aricept®. ADLARITY is the first approved prescription drug product using Corium's proprietary CORPLEXTM transdermal technology, which has been used for years in consumer products. About ADHD ADHD is a common neurodevelopment disorder marked by an ongoing pattern of inability to pay attention or hyperactivity with impulsive behaviors, or both, which interferes with functioning or development. ADHD usually is diagnosed during childhood but often continues into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active. In the United States, an estimated 6.1 million children have received an ADHD diagnosis, including 2.4 million aged 6 to 11 years. 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. The related behavioral changes include the loss of independence in activities of daily living and self-care. Dementia ranges in severity from mild, when it is just beginning to affect a person's functioning, to severe, when the person must depend on others for the basic activities of day-to-day life. An estimated 6.2 million Americans were living with Alzheimer's disease in 2021, with a possible rise to 13.8 million by 2060. Globally, more than 55 million people have dementia, and Alzheimer's disease may account for 60 to 70 percent of patients with dementia, according to the World Health Organization. The U.S. Centers for Disease Control and Prevention estimates that in 2020, more than 11 million Americans provided an estimated 15.3 billion hours of unpaid care for patients with Alzheimer's disease. Indication and Important Safety Information for AZSTARYS (serdexmethylphenidate and dexmethylphenidate) INDICATION AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Known hypersensitivity to serdexmethylphenidate, methylphenidate, or other product components. Bronchospasm, rash, and pruritus have occurred with AZSTARYS. Hypersensitivity reactions such as angioedema and anaphylactic reactions have occurred with other methylphenidate products. Concomitant treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days, because of the risk of hypertensive crisis. WARNINGS AND PRECAUTIONS Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported at recommended doses. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, coronary artery disease, or other serious heart problems. CNS stimulants cause an increase in blood pressure and heart rate. Monitor all patients for hypertension and tachycardia. Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a history of psychotic illness or mania. Discontinue if symptoms occur. Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed. CNS stimulants, including AZSTARYS, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Carefully observe patients during treatment for digital changes. Further evaluation may be required, including referral. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor height and weight at appropriate intervals in pediatric patients. Treatment may need to be interrupted in children not growing or gaining weight as expected. ADVERSE REACTIONS Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased. DRUG INTERACTIONS Adjust dosage of antihypertensive drug as needed. Monitor blood pressure. Avoid use of AZSTARYS on the day of surgery if halogenated anesthetics will be used. For additional safety information, click here for Prescribing Information and Medication Guide, including BOXED WARNING. 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 Corium Corium, Inc., is a commercial-stage biopharmaceutical company that is leading the development and commercialization of CNS therapies that provide clinicians with important new treatment options for patients, their families, and their caregivers. Corium is commercializing two U.S. FDA approved products, ADLARITY and AZSTARYS. Corium has a robust development pipeline focused on addressing unmet needs in the treatment of patients with CNS conditions. In November 2018, all of Corium's outstanding stock was acquired by an affiliate of Gurnet Point Capital. For further information, please visit . About Gurnet Point Capital Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, GPC is able to deliver differentiated results for its investors and partners. For more, go to . Contact: Corium, Inc. Gartmanpr@gmail.com 202-413-4226