memantine ER / Generic mfg. - LARVOL DELTA

Memantine for Enhanced Stroke Recovery (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: University of Utah | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

Amneal Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules… (Businesswire) - "Amneal Pharmaceuticals, Inc...today announced that the U.S. Food and Drug Administration (FDA) has approved memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules, which references Abbvie’s NAMZARIC...Memantine/donepezil extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. The product has launched with 180-day exclusivity."

ANDA • Alzheimer's Disease • Dementia

Memantine for Enhanced Stroke Recovery (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: University of Utah | Trial completion date: Dec 2023 ➔ May 2025 | Trial primary completion date: Dec 2023 ➔ May 2025

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

NTS-WBRT in Brain Metastases (clinicaltrials.gov) - P2 | N=41 | Recruiting | Sponsor: Massachusetts General Hospital | Phase classification: P=N/A ➔ P2

Phase classification • Oncology • Solid Tumor

NTS-WBRT in Brain Metastases (clinicaltrials.gov) - P=N/A | N=41 | Recruiting | Sponsor: Massachusetts General Hospital | Phase classification: P2 ➔ P=N/A | N=100 ➔ 41

Enrollment change • Phase classification • Oncology • Solid Tumor

Memantine for Enhanced Stroke Recovery (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: University of Utah | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

"He needs his namenda XR cheaper" (@Raddinero)

"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)

NTS-WBRT VS HA-WBRT in Brain Metastases (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Memantine XR and Pregabalin for Chemotherapy-Induced Peripheral Neuropathy (clinicaltrials.gov) - P=N/A | N=20 | Completed | Sponsor: Saint John's Cancer Institute | Trial completion date: Aug 2019 ➔ Apr 2021 | Trial primary completion date: Aug 2017 ➔ Apr 2021

Combination therapy • Trial completion date • Trial primary completion date • Pain

Memantine XR and Pregabalin for Chemotherapy-Induced Peripheral Neuropathy (clinicaltrials.gov) - P=N/A | N=20 | Completed | Sponsor: John Wayne Cancer Institute | Recruiting ➔ Completed

Combination therapy • Trial completion • Pain

Memantine for Enhanced Stroke Recovery (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: University of Utah | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (uPRDR) Technique (clinicaltrials.gov) - P2; N=53; Not yet recruiting; Sponsor: Medical College of Wisconsin

New P2 trial • Oncology • Solid Tumor

NTS-WBRT VS HA-WBRT in Brain Metastases (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Massachusetts General Hospital

Clinical • New P2 trial • Oncology • Solid Tumor • MRI

Memantine for Enhanced Stroke Recovery (clinicaltrials.gov) - P1; N=20; Active, not recruiting; Sponsor: University of Utah; Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Ischemic stroke • MRI

Drugs for Parkinson's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Depression • Movement Disorders • Parkinson's Disease • Psychiatry

Memantine for Enhanced Stroke Recovery (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: University of Utah; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Jul 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

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

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

Patent • Alzheimer's Disease • CNS Disorders

Seven Lundbeck drugs banned in Ukraine [Google translation] (KP.UA News) - "The State Service of Ukraine for Medicines (State Medicines Service) has banned the use and sale of six drugs produced by H. Lundbeck A / S (Denmark). All of them were not officially imported into our country, so the manufacturer withdrew the medicine. Antipsychotics and antidepressants BRINTELLIX - 28 tablets, 10 mg each; SERDOLECT - tablets 4 mg, 12 mg and 16 mg; Fluanxol Depot, 20 mg ampoule, 10x1 ml; EBIXA - 10 mg Tablets CLOPIXOL ACUPHASE, 1 ampoule intramuscularly 50 mg 1 ml..."

Commercial • CNS Disorders • Depression • Schizophrenia

Memantine XR and Pregabalin for Chemotherapy-Induced Peripheral Neuropathy (clinicaltrials.gov) - P=N/A; N=20; Recruiting; Sponsor: John Wayne Cancer Institute; Trial completion date: Dec 2019 ➔ Dec 2022; Trial primary completion date: Dec 2019 ➔ Dec 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Pain

Bioequivalence study of two formulations of memantine hydrochloride tablets in healthy male Chinese subjects under fasting and fed conditions. (PubMed, Int J Clin Pharmacol Ther) - "The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state. That is to say, the test formulation of memantine 10-mg tablet is bioequivalent to the reference formulation (Ebixa 10-mg tablet)."

Clinical • Journal • Alzheimer's Disease • CNS Disorders

The use of Akatinol Memantine in the treatment of gait disturbances in Parkinson's disease (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "The improvement in gait achieved during the study confirms that the treatment of cortical gait disturbances in patients with PD using memantine hydrochloride is a promising area of therapy."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies. (PubMed, Autism) - "Three phase 2 trials were conducted to assess the efficacy and long-term safety of weight-based memantine extended release (ER) treatment in children with autism spectrum disorder...No new safety concerns were evident. While the a priori-defined efficacy results of the double-blind trial were not achieved, the considerable improvements in mean Social Responsiveness Scale scores from baseline in the open-label trials were presumed to be clinically important."

Clinical • Journal • P2 data • Developmental Disorders • Genetic Disorders • Psychiatry

[VIRTUAL] Masupirdine in Combination with Donepezil and Memantine in Patients with Moderate Alzheimer's Disease: Subgroup Analyses of Memantine Regimen, Plasma Concentrations and Duration of Treatment (AAIC 2020) - "All patients were treated with donepezil 10 mg + memantine 10 mg BID or Namenda XR 28 mg QD; or Namzaric (donepezil 10 mg + 28 mg Namenda XR). Subgroup analyses of the masupirdine Phase 2 POC study to assess potential effects of memantine regimen, memantine plasma concentrations and duration of treatment on primary and secondary study outcomes revealed several potential signals for differential effects favoring masupirdine treatment. These observations merit better understanding and further possible investigations of masupirdine as a potential treatment for AD dementia."

Clinical • Combination therapy • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia