Adlarity (donepezil transdermal system) / Corium, Alvogen Korea - LARVOL DELTA

The donepezil transdermal system for the treatment of patients with mild, moderate, or severe Alzheimer's disease: a critical review. (PubMed, Expert Rev Neurother) - "Cholinesterase inhibitors, along with memantine, are the mainstay of symptomatic treatment for AD (Alzheimer's disease); however, these medications are typically administered orally, which can be difficult for people with AD and their caregivers...The authors also compare the patch to the only other transdermal cholinesterase inhibitor on the market, rivastigmine, and highlight the potential advantages and disadvantages between these two treatments...In addition, there is no high dose (e.g. 23 mg) equivalent. Nevertheless, transdermal donepezil will be useful for people with AD and their caregivers, given its effectiveness and potential convenience."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

A Randomized Double-blind Study to Assess the Skin Irritation and Sensitization Potential of a Once-weekly Donepezil Transdermal Delivery System in Healthy Volunteers. (PubMed, Alzheimer Dis Assoc Disord) - "Once-weekly 5-mg/d donepezil TDS demonstrated minimal skin irritation under conditions of use of 3 consecutive weekly patch applications to the same skin site and minimal sensitization potential."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Dementia

Corium Announces Publication of Favorable ADLARITY (donepezil transdermal system) Skin Irritation Clinical Trial Data (PRNewswire) - P1 | N=256 | NCT03397862 | Sponsor: Corium, Inc. | "Corium, LLC...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....The data appear in the October-December 2023 issue of the peer-reviewed Alzheimer's Disease and Associated Disorders journal.... 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."

P1 data • Alzheimer's Disease • CNS Disorders

A study of once-a-week donepezil transdermal system's bioequivalence to oral donepezil in healthy volunteers: a plain language summary. (PubMed, Neurodegener Dis Manag) - "Donepezil TDS also had fewer instances of nervous system side effects (like dizziness and sleepiness) than the oral donepezil pill. These findings support using donepezil TDS to treat patients with Alzheimer's disease."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Constipation • Dementia • Gastroenterology • Gastrointestinal Disorder • Pain

Your Guide to FDA-Approved Alzheimer's Drugs (Being Patient) - "As Dr. Andrew Budson...told Being Patient: 'One way to think about Alzheimer's disease is as a clock that is ticking down until you run out of time, and your memory and other cognitive functions are gone. By blocking the metabolism of acetylcholine, the cholinesterase inhibitors drugs galantamine, donepezil, and rivastigmine can boost up memory equivalent to turning back the clock on Alzheimer's disease by six to 12 months.'"

Media quote

Corium and Lotus Pharmaceutical Enter into Exclusive License Agreement for Innovative Alzheimer's Disease Treatment ADLARITY in Multiple Markets Across Asia (Businesswire) - "Corium...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....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."

Licensing / partnership • Alzheimer's Disease • CNS Disorders • Dementia

A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Donepezil Transdermal Delivery System (AGS-AM 2023) - "Once-weekly 5-mg/d donepezil TDS demonstrated minimal skin irritation under use conditions of 3 consecutive weekly patch applications to the same skin site and minimal sensitization potential."

A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Donepezil Transdermal Delivery System (AAN 2023) - P1 | "Of 198 participants, 4 (2.0%) were considered potentially sensitized to donepezil TDS, and 0 were potentially sensitized to placebo TDS. Conclusions Once-weekly 5-mg/d donepezil TDS demonstrated acceptable skin tolerability, with minimal skin irritation under conditions of use of 3 consecutive weekly patch applications to the same skin site and minimal sensitization potential, supporting its use as treatment for dementia of the Alzheimer type."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia

Corium's New Once-Weekly Transdermal Alzheimer's Dementia Therapy ADLARITY (donepezil transdermal system) Provides Drug Delivery Equivalent to Oral Donepezil With Favorable GI Side Effect Profile (PRNewswire) - "'The doses of the once-weekly donepezil transdermal system were equivalent to oral donepezil on a milligram-per-day basis, and the safety profile of the transdermal system formulation, including the lower overall incidence of GI side effects, support its use in treating patients with dementia of the Alzheimer's type,' said Pierre N. Tariot, MD..."

Media quote

A RANDOMIZED DOUBLE-BLIND STUDY TO ASSESS THE SKIN IRRITATION AND SENSITIZATION POTENTIAL OF ONCE-WEEKLY DONEPEZIL TRANSDERMAL DELIVERY SYSTEM. (CTAD 2022) - P1 | "Once-weekly 5-mg donepezil TDS demonstrated acceptable skin tolerability, with minimal skin irritation under conditions of use of 3 consecutive weekly patch applications to the same skin site and minimal sensitization potential, supporting its use as treatment for dementia of the Alzheimer’s type."

Clinical • Allergy • Alzheimer's Disease • CNS Disorders • Dementia • Dermatology • Immunology

Bioequivalence and safety comparison of once-weekly donepezil transdermal system with oral donepezil: results of a phase 1 pharmacokinetic study in healthy volunteers (AAIC 2022) - No abstract available

Clinical • P1 data • PK/PD data

Bioequivalence and Safety Comparison of Once Weekly Donepezil Transdermal System with Once-Daily Oral Donepezil: Results of a Phase 1 Trial in Healthy Volunteers (ANA 2022) - P1 | "Both donepezil TDS strengths were bioequiv alent to oral donepezil on a mg/d basis. The safety profile of donepezil TDS supports its use in treating dementia of the Alzheimer type."

Clinical • P1 data • Alzheimer's Disease • CNS Disorders • Dementia • Pain

Evaluation of Skin Adhesion and Local Skin Tolerability of Once-Weekly Donepezil Transdermal System: Results of a Phase 1 Trial in Healthy Volunteers (ANA 2022) - P1 | "Once-weekly 5-mg/d and 10-mg/d donepezil TDSs demonstrated acceptable skin adhesion and skin tolera bility, supporting their use as treatment for dementia of the Alzheimer type."

Clinical • P1 data • Alzheimer's Disease • CNS Disorders • Dementia

Corium Launches ADLARITY (donepezil transdermal system) for Patients with Alzheimer's Dementia (PRNewswire) - “Corium, Inc…announced today that ADLARITY (donepezil transdermal system) is now available for prescription in the U.S. for the treatment of patients with mild, moderate, or severe dementia of the Alzheimer's type….ADLARITY became available through wholesalers as of September 19, 2022, and has received first-line formulary coverage for patients with some commercial insurances, with more expected as the year progresses. Corium is working with the U.S. Centers for Medicare and Medicaid Services toward greater patient accessibility through government-sponsored programs, including Medicare Part D, with coverage expected to begin in 2023. Corium is taking a phased approach to launching ADLARITY. As Medicare becomes available, Corium will broaden launch efforts, with a nationwide launch planned for 2023.”

Launch US • Reimbursement • Alzheimer's Disease • CNS Disorders

Comparison of Steady-State Pharmacokinetics of Donepezil Transdermal Delivery System with Oral Donepezil. (PubMed, J Alzheimers Dis) - P1 | "Donepezil TDSs are bioequivalent to oral donepezil at steady state and have a safety profile that supports their use in treating dementia of the Alzheimer type."

Journal • PK/PD data • Alzheimer's Disease • CNS Disorders • Dementia • Gastrointestinal Disorder

Corium Announces Publication of ADLARITY (donepezil transdermal system) Clinical Trial Data: Drug Exposure Equivalent to Oral Donepezil With Favorable GI Side Effect Profile (PRNewswire) - P1 | N=60 | NCT04617782 | Sponsor: Corium, Inc. | "Corium, Inc...announced publication of its phase 1 healthy volunteer study results for ADLARITY (donepezil transdermal system) in the peer-reviewed Journal of Alzheimer's Disease....The article is currently available online and expected to be published in the hardcopy of the Journal of Alzheimer's Disease, Volume 90, Issue 1, on October 25, 2022....Per FDA guidance, two pharmaceutical products are bioequivalent if the 90% confidence interval of the geometric mean ratio (GMR) for AUC and Cmax is within 80–125%. The study concluded that the GMR for AUC and Cmax were within the bioequivalence range when comparing the 10 mg/day ADLARITY transdermal system to 10 mg/day oral donepezil."

P1 data • Alzheimer's Disease • CNS Disorders

Corium to Present Positive Data on ADHD Medication AZSTARYS (serdexmethylphenidate and dexmethylphenidate) and Alzheimer's Disease Medication ADLARITY (donepezil transdermal system) at Psych Congress 2022 (Yahoo Finance) - "Corium, Inc...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."

P1 data • Alzheimer's Disease • CNS Disorders

Comparison table: Drugs for Alzheimer's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders

Drugs for cognitive loss and dementia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders • Dementia

A donepezil patch (Adlarity) for Alzheimer's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders

Corium's New Once-Weekly Transdermal Alzheimer's Dementia Therapy ADLARITY (donepezil transdermal system) Provides Drug Delivery Equivalent to Oral Donepezil With Favorable GI Side Effect Profile (PRNewswire) - P1 | N=60 | NCT04617782 | Sponsor: Corium, Inc. | "Corium, Inc…announced today that both strengths of its new once-weekly ADLARITY (donepezil transdermal system) maintain equivalent daily exposure of donepezil when compared to oral formulations of donepezil, along with a favorable overall gastrointestinal (GI) side effect profile….In the study, fewer overall gastrointestinal AEs occurred with administration of 10-mg/day ADLARITY than 10 mg/day oral donepezil: 14.5% vs. 53.6%, respectively….ADLARITY Launch: Corium will begin its initial launch of ADLARITY in early fall 2022...In 2023, Corium will begin the national phase of the launch and further build out its commercial team in conjunction with ADLARITY becoming covered by Medicare Part D. In the interim, Corium will continue to expand coverage for and access to ADLARITY with other health insurers and engage in medical education activities."

Launch • P1 data • Reimbursement • Alzheimer's Disease • CNS Disorders

KemPharm Earns $1.975 Million Fee from Corium Following FDA Approval of the Corium Product ADLARITY (donepezil transdermal system) (GlobeNewswire) - “KemPharm, Inc…announced that the Company has earned a $1.975 million fee from Corium, Inc., (Corium), a portfolio company of Gurnet Point Capital, following the approval of Corium’s product ADLARITY® (donepezil transdermal system) by the U.S. Food and Drug Administration (FDA) on March 11, 2022. ADLARITY is an innovative new treatment option for patients with mild, moderate, or severe dementia of the Alzheimer's type.”

Commercial • Alzheimer's Disease • CNS Disorders

Corium Receives FDA Approval of ADLARITY (donepezil transdermal system) for Treatment of Patients with Alzheimer's Disease (PRNewswire) - “Corium, Inc…announced today the U.S. Food and Drug Administration (FDA) has approved Corium's ADLARITY (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of the Alzheimer's type. 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 adverse gastrointestinal (GI) side effects associated with oral donepezil. ADLARITY is the first approved prescription drug product using Corium's proprietary CORPLEX transdermal technology, which has been used for years in consumer products.”

NDA • Alzheimer's Disease • CNS Disorders

Corium Receives March 11, 2022 PDUFA Date for New Drug Application for ADLARITY Patch (donepezil transdermal system) for Treatment of Patients with Alzheimer's Disease (PRNewswire) - 'Corium, Inc...announced today the U.S. Food and Drug Administration (FDA) set a Prescription Drug User Fee (PDUFA) target action date of March 11, 2022 for Corium's new drug application (NDA) for once-weekly ADLARITY (donepezil transdermal system), its lead investigational product and a patch formulation of donepezil for the treatment of patients with dementia due to mild, moderate, or severe Alzheimer's disease. If approved, ADLARITY would be Corium's second CNS product approved for the U.S. market in 12 months.'

PDUFA date • Alzheimer's Disease • CNS Disorders

Crossover Pharmacokinetic (PK) Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: Corium, Inc.; Not yet recruiting ➔ Completed

Clinical • Trial completion