Namzaric (memantine ER/donepezil) / AbbVie, Supernus Pharma - LARVOL DELTA

Comparative evaluation of FDA-approved drugs for managing the symptoms of AD (AAIC 2023) - "Although there are disease modifying drugs target the amyloids such as Aducanumab and Lecanemab, high costs (around $30,000/year) and severe side effects make them unfavorable for many patients suffering from AD. MCDM methods can be used as a decision-aid system for evaluating AD drugs and this study can be extended including more criteria and new drugs as they become available."

FDA event • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Comparative evaluation of FDA-approved drugs for managing the symptoms of AD (AAIC 2023) - "Although there are disease modifying drugs target the amyloids such as Aducanumab and Lecanemab, high costs (around $30,000/year) and severe side effects make them unfavorable for many patients suffering from AD. MCDM methods can be used as a decision-aid system for evaluating AD drugs and this study can be extended including more criteria and new drugs as they become available."

FDA event • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Comparative evaluation of FDA-approved drugs for managing the symptoms of AD (AAIC 2023) - "Although there are disease modifying drugs target the amyloids such as Aducanumab and Lecanemab, high costs (around $30,000/year) and severe side effects make them unfavorable for many patients suffering from AD. MCDM methods can be used as a decision-aid system for evaluating AD drugs and this study can be extended including more criteria and new drugs as they become available."

FDA event • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Comparative evaluation of FDA-approved drugs for managing the symptoms of AD (AAIC 2023) - "Although there are disease modifying drugs target the amyloids such as Aducanumab and Lecanemab, high costs (around $30,000/year) and severe side effects make them unfavorable for many patients suffering from AD. MCDM methods can be used as a decision-aid system for evaluating AD drugs and this study can be extended including more criteria and new drugs as they become available."

FDA event • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

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

"NAMZARIC capsules: 14 mg memantine hydrochloride extended-release/10 mg donepezil hydrochloride capsules If you still can't find it, you may be able to find the 2 separate active ingredients and have the doctor change the script" (@Rx_Post)

SPiRiT: Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy (clinicaltrials.gov) - P3 | N=108 | Recruiting | Sponsor: Duke University | Trial completion date: Apr 2022 ➔ Apr 2024 | Trial primary completion date: Apr 2022 ➔ Apr 2024

HEOR • Trial completion date • Trial primary completion date • Brain Cancer • Immunology • Lung Cancer • Oncology • Solid Tumor

The Dose- and Duration-Dependent Association between Melatonin Treatment and Overall Cognition in Alzheimer's Dementia: A Network Meta-Analysis of Randomized Placebo-Controlled Trials. (PubMed, Curr Neuropharmacol) - "The current NMA provides evidence for the potential benefits of exogenous melatonin supplementation, especially medium-term low-dose melatonin, in participants with AD."

Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Mental Retardation • Psychiatry

SPiRiT: Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy (clinicaltrials.gov) - P3 | N=108 | Recruiting | Sponsor: Duke University | Not yet recruiting ➔ Recruiting

Enrollment open • HEOR • Brain Cancer • Immunology • Lung Cancer • Oncology • Solid Tumor

SPiRiT: Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy (clinicaltrials.gov) - P3; N=108; Not yet recruiting; Sponsor: Duke University; Initiation date: May 2021 ➔ Aug 2021

Clinical • HEOR • Trial initiation date • Brain Cancer • Immunology • Lung Cancer • Oncology • Solid Tumor

Adamas Reports Second Quarter 2021 Financial Results (Businesswire) - "Total revenues were $22.0 million for the second quarter of 2021, consisting of GOCOVRI product sales of $20.1 million, OSMOLEX ER product sales of $0.5 million and royalty revenue earned on net sales of NAMZARIC® (memantine hydrochloride extended release and donepezil hydrochloride) capsules of $1.4 million. GOCOVRI product sales were up 12% compared to $18.0 million in the same period in 2020....SG&A expenses for the second quarter of 2021 were $29.2 million, compared to $23.2 million for the same period in the prior year. SG&A expenses in the second quarter of 2021 were primarily attributable to sales force costs and external spend dedicated to GOCOVRI commercialization and the related administrative support as well as the integration and initial promotion of OSMOLEX ER."

Commercial • Sales • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

SPiRiT: Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy (clinicaltrials.gov) - P3; N=108; Not yet recruiting; Sponsor: Duke University; Initiation date: Jan 2021 ➔ May 2021

Clinical • HEOR • Trial initiation date • Brain Cancer • Immunology • Lung Cancer • Oncology • Solid Tumor

Adamas Reports Fourth Quarter and Full Year 2020 Financial Results (Businesswire) - "Total revenue was $21.0 million for the fourth quarter of 2020...royalty revenue earned on net sales of NAMZARIC (memantine hydrochloride extended release and donepezil hydrochloride) capsules of $1.2 million....Total revenue was $74.5 million for full year 2020...royalty revenue earned on net sales of NAMZARIC of $3.3 million."

Commercial • Alzheimer's Disease • CNS Disorders

Novel Variants in the CLCN1, RYR2, and DCTN1 Found in Elderly Japanese Dementia Patients: A Case Series. (PubMed, Geriatrics (Basel)) - "Patient 1 was treated with donepezil; Patient 2 was treated with donepezil and memantine; and Patient 6 was treated with donepezil, galantamine, and rivastigmine. Our report suggests that results of genetic tests in elderly patients with dementia need to be carefully interpreted. Further data accumulation of genotype-phenotype relationships and development of appropriate functional models are warranted."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Frontotemporal Lobar Degeneration • Immunology • Movement Disorders • Parkinson's Disease • DCTN1

Influence of Acetylcholine Esterase Inhibitors and Memantine, Clinically Approved for Alzheimer's Dementia Treatment, on Intestinal Properties of the Mouse. (PubMed, Int J Mol Sci) - "Three of these drugs-donepezil, rivastigmine, and galantamine-belong to the class of acetylcholine esterase inhibitors. Memantine, a NMDA receptor antagonist, represents the fourth and a combination of donepezil and memantine the fifth treatment option...Both, acetylcholine esterase inhibitors and memantine, had no effect on general viability and neurite outgrowth of enteric neurons. In sum, our findings indicate that all AD symptomatic drugs have the potential to affect distinct intestinal functions and with this-directly or indirectly-microbial commensals."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Gastrointestinal Disorder

Lawyer opposes Allergan’s bid for interlocutory appeal in FCA suit (Life Sciences Intellectual Property Review (LSIPR)) - "Allergan should not be permitted to immediately appeal against a recent ruling which requires it to face allegations that it monopolised the pricing of dementia drugs...Zachary Silbersher, founding partner of IP law firm Kroub, Silbersher & Kolmykov, filed his opposition brief...Silbersher accused Allergan of misleading the US Patent and Trademark Office into issuing invalid patents for Namenda XR (memantine hydrochloride) and Namzaric...In December 2020, the court rejected Allergan’s bid to dismiss the FCA lawsuit. Allergan asked the court to certify an interlocutory appeal order...Silbersher filed an opposition to Allergan’s motion....Currently, the matter can be ready for trial within 18 months, but an interlocutory appeal—which may take more than two years—would 'unnecessarily delay the case beyond the expected trial date', Silbersher said."

Patent • Alzheimer's Disease • CNS Disorders • Dementia

A Retrospective Study on the Benefits of Combined Citicoline, Memantine, and Acetylcholinesterase Inhibitor Treatments in Older Patients Affected with Alzheimer's Disease. (PubMed, J Alzheimers Dis) - "In older patients with AD, a triple therapy with citicoline, memantine, and AChEI was more effective than memantine and AChEI without citicoline in maintaining the MMSE total score after 12 months."

Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Mental Retardation

Crocus sativus L. (Saffron) in Alzheimer's disease treatment: bioactive effects on cognitive impairment. (PubMed, Curr Neuropharmacol) - "Only four clinical studies have indicated that the effects of saffron on cognitive impairment were not different from those produced by donepezil and memantine and that it had a better safety profile. Saffron and its compounds should be further investigated in order to consider them a safer alternative in AD treatment."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Pain

Adamas Provides Preliminary Fourth Quarter and Full Year 2020 Total Revenues and Key Business Drivers for 2021 (GlobeNewswire) - "Full year 2020 GOCOVRI product sales are anticipated to be $71.2 million compared to $54.6 million for full year 2019, an increase of 30%. Total paid prescriptions (TRx) of GOCOVRI were approximately 31,070 for 2020, a 21% increase over approximately 25,780 TRx for 2019...GOCOVRI product sales for the fourth quarter of 2020 are expected to be $19.8 million, an increase of 21% from $16.3 million in the fourth quarter of 2019...Royalty revenue on net sales of NAMZARIC is estimated to be $1.0 million in the fourth quarter of 2020 and $3.0 million for full year 2020...Key business drivers for 2021....Earn a full year of royalty revenue from sales of NAMZARIC."

Commercial • Sales • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

[VIRTUAL] TREATMENT OPTIONS FOR SLEEP-RELATED EPILEPTIC SPIKING IN EARLY ALZHEIMER’S DISEASE (ADPD 2021) - "We will test the standard ADdrugs donepezil and memantine, anti-epileptic drugs levetiracetam and lamotrigine, gamma-secretase inhibitor semagacestat and an anti-inflammatory tetracycline derivative minocycline at doses with no overt motor manifestations. Sleep-related epileptic spiking in AD is treatable with clinically approved drugs."

Alzheimer's Disease • CNS Disorders • Epilepsy • Immunology

The Psychopharmacology Algorithm Project at the Harvard South Shore Program: An update on management of behavioral and psychological symptoms in dementia. (PubMed, Psychiatry Res) - "We propose three algorithms: BPSD in an emergent, urgent, and non-urgent setting. In the emergent setting when intramuscular (IM) administration is necessary, the first-line recommendation is for olanzapine (since IM aripiprazole, previously favored, is no longer available) and haloperidol injection is the second choice, followed by possible consideration of an IM benzodiazepine. In the urgent setting, the first line would be oral second-generation antipsychotics (SGAs) aripiprazole and risperidone...Dosing strategies, discontinuation considerations, and side effects are discussed. In the non-emergent setting, medications are proposed for use in the following order: trazodone, donepezil and memantine, antidepressants such as escitalopram and sertraline, SGAs, prazosin, and carbamazepine. Other options with less support but potential future promise are discussed."

Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia • Epilepsy • Geriatric Disorders • Psychiatry

Allergan Must Face FCA Claims Over Dementia Drug Patents (Law360) - Subscription needed.

Patent • Alzheimer's Disease • CNS Disorders

Adamas Reports Third Quarter 2020 Financial Results (GlobeNewswire) - "GOCOVRI product sales were $19.0 million in the third quarter of 2020, an increase of 36% as compared to $13.9 million in the third quarter of 2019. Total paid prescriptions (TRx) of GOCOVRI were approximately 7,930 in the third quarter of 2020, a 19% increase over approximately 6,640 TRx in the third quarter of 2019....The U.S. Food and Drug Administration approved the supplemental new drug application to add AMSA S.p.A. as a secondary supplier of active pharmaceutical ingredients for GOCOVRI.The Company recognized $1.2 million of royalty revenue on net sales of NAMZARIC® in the third quarter of 2020."

Commercial • Sales • sNDA • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

SPiRiT: Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy (clinicaltrials.gov) - P3; N=108; Not yet recruiting; Sponsor: Duke University

Clinical • HEOR • New P3 trial • Brain Cancer • Lung Cancer • Oncology • Solid Tumor