Sodium channel blockers

DGAP-News: Newron Pharmaceuticals provides clinical and business update

Retrieved on: 
Tuesday, August 11, 2020
Health, Medical research, Sodium channel blockers, Antipsychotics, Evenamide, Phenethylamines, Clinical research, Pharmaceutical industry, Clinical trial

All evenamide pre-clinical studies requested by FDA completed and first clinical safety study initiated; on track to initiate evenamide Phase III program in 2021

Key Points: 
  • All evenamide pre-clinical studies requested by FDA completed and first clinical safety study initiated; on track to initiate evenamide Phase III program in 2021
    Milan, Italy and Morristown, NJ, USA, August 11, 2020 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today provided a clinical and business update.
  • Newron has now initiated the first clinical safety study (008)."
  • Newron intends to recruit approximately 120 patients into the study at study centers in the United States and India.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Cenobamate Designated Promising Innovative Medicine (PIM) by the UK’s MHRA for Treatment of Drug-Resistant Focal-Onset Seizures in Adults

Retrieved on: 
Tuesday, August 11, 2020
RTT, Clinical medicine, Organ systems, Epileptic seizure, Health, Epilepsy, Anticonvulsants, Sodium channel blockers, GABAA receptor positive allosteric modulators

Commenting on the announcement, Stuart Mulheron, General Manager UK & Ireland, Arvelle Therapeutics said: The MHRA PIM designation marks an important milestone for Arvelle.

Key Points: 
  • Commenting on the announcement, Stuart Mulheron, General Manager UK & Ireland, Arvelle Therapeutics said: The MHRA PIM designation marks an important milestone for Arvelle.
  • To date, cenobamate has been approved by the US Food and Drug Administration (FDA) for the treatment of partial-onset (focal) seizures in adults, and is commercially available in the U.S.
  • In March 2020, Arvelle announced the European Medicines Agencys (EMA) acceptance of the marketing authorization application (MAA) for cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy.
  • Cenobamate was discovered by SK Biopharmaceuticals and SK life science and is a new FDA-approved anti-seizure medication (ASM) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures).

Eton Pharmaceuticals Submits New Drug Application to the FDA for Zonisamide Oral Suspension (ET-104)

Retrieved on: 
Thursday, July 30, 2020
Anticonvulsants, RTT, Sodium channel blockers, Organ systems, Carbonic anhydrase inhibitors, Drugs, Chemical compounds, GABAA receptor positive allosteric modulators, Lamotrigine, Topiramate, Zonisamide, Epilepsy in animals

Zonisamide is widely used as a capsule to treat partial seizures, but the molecule is not FDA approved in liquid form.

Key Points: 
  • Zonisamide is widely used as a capsule to treat partial seizures, but the molecule is not FDA approved in liquid form.
  • Based on IQVIA data, more than 150,000 prescriptions of zonisamide are written annually for the treatment of epilepsy.
  • ET-104 is one of Etons three neurology-focused liquid product candidates, along with ET-105 (lamotrigine oral suspension) and ET-101 (topiramate oral solution).
  • The companys lead pediatric product is the orphan drug Alkindi Sprinkle, which is currently under review with the FDA.

Clearside Biomedical Announces Multiple Presentations at the ASRS 2020 Virtual Annual Meeting

Retrieved on: 
Monday, July 27, 2020
Drugs, Psychoactive drugs, Neurochemistry, RTT, Sodium channel blockers, Medicinal chemistry, Pharmacodynamics, Pharmacy, Vascular endothelial growth factor, Ketamine

This year, ASRS held a successful annual meeting with a virtual format that allowed for easy access to presentations and interactions with treating physicians.

Key Points: 
  • This year, ASRS held a successful annual meeting with a virtual format that allowed for easy access to presentations and interactions with treating physicians.
  • CLS-AX demonstrated intrinsic high potency, pan-VEGF inhibition through receptor blockade, prolonged duration observed in pharmacokinetic studies, and a pharmacodynamic effect in multiple animal models.
  • Copies of these presentations will be available on Clearsides website under the Publications & Presentations page here: https://www.clearsidebio.com/publications.htm .
  • Preclinical results from Clearside and independent investigators have showed pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage.

Cardiff Oncology Data Continues to Demonstrate Efficacy, Durability and Safety of Onvansertib in Patients with Difficult-to-Treat Relapsed/Refractory AML

Retrieved on: 
Monday, June 15, 2020
Drugs, Psychoactive drugs, Neurochemistry, Chloroarenes, Sodium channel blockers, Ketamine, RTT

The presentation highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data.

Key Points: 
  • The presentation highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data.
  • Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window.
  • Patients will receive onvansertib, administered orally, on days 1 through 5 of each 21-28-day cycle in combination with decitabine.
  • The primary efficacy endpoint of objective response (CR + CRi) will be assessed in patients who complete at least 1 cycle of treatment.

US FDA Grants Mexiletine Orphan Drug Designation

Retrieved on: 
Monday, June 8, 2020
Health, Articles, Organ systems, Antiarrhythmic agents, Local anesthetics, Sodium channel blockers, Analgesics, Mexiletine, Orphan drug, Food and Drug Administration, Myotonia

Zug, Switzerland, 8 June 2019: Lupin is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to mexiletine hydrochloride for the treatment of myotonic disorders.

Key Points: 
  • Zug, Switzerland, 8 June 2019: Lupin is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to mexiletine hydrochloride for the treatment of myotonic disorders.
  • Mexiletine reduces myotonia symptoms, resulting in a significant improvement in patient quality-of-life and other functional outcomes1.
  • The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
  • The decision by the US FDA to grant orphan drug designation to mexiletine brings us closer to providing a licensed treatment option for patients in the US, and we are pleased to have this opportunity to further our commitment to these patients.

Newron Pharmaceuticals to Present at the Jefferies Virtual Healthcare Conference

Retrieved on: 
Friday, May 29, 2020
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Life sciences, Articles, Biotechnology, Sodium channel blockers, Antipsychotics, Evenamide, Phenethylamines, Xetra, Xetra, Biopharmaceutical

Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that Stefan Weber, CEO, will present at the upcoming Jefferies Virtual Healthcare Conference on Tuesday, June 2nd, 2020 at 9:30 a.m. EDT.

Key Points: 
  • Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that Stefan Weber, CEO, will present at the upcoming Jefferies Virtual Healthcare Conference on Tuesday, June 2nd, 2020 at 9:30 a.m. EDT.
  • Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system.
  • Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories.
  • Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Arvelle Therapeutics: SK Life Science, Inc. Announces US Availability of XCOPRI® (cenobamate tablets) for the Treatment of Partial (Focal) Onset Seizures in Adults with Epilepsy

Retrieved on: 
Tuesday, May 12, 2020
Epilepsy, RTT, Medicine, Organ systems, Clinical medicine, Anticonvulsants, Epileptic seizure, GABAA receptor positive allosteric modulators, Sodium channel blockers, Responsive neurostimulation device, Epilepsy syndromes

XCOPRI was recently approved by the US Food and Drug Administration (FDA) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures).

Key Points: 
  • XCOPRI was recently approved by the US Food and Drug Administration (FDA) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures).
  • Approximately 40% of adult patients with epilepsy have inadequate control of seizures after treatment with two antiseizure medication regimens1,2, making access to XCOPRI a significant treatment option for patients.
  • To help US based patients commence and continue their treatment program on XCOPRI, SK life science has developed an extensive new patient access program called SK life science navigator.
  • Cenobamate was discovered by SK Biopharmaceuticals and SK life science and is a new FDA-approved antiseizure medication (ASM) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures).

DGAP-News: Newron AGM Result and Clinical and Business Update

Retrieved on: 
Tuesday, March 31, 2020
Sodium channel blockers, Antipsychotics, Evenamide, Phenethylamines, Schizophrenia, Caregiver, Drugs, Human behavior, Humans

Newron today also provides an update on its clinical, business and operational activities, in light of the recent COVID-19 pandemic.

Key Points: 
  • Newron today also provides an update on its clinical, business and operational activities, in light of the recent COVID-19 pandemic.
  • The health and safety of patients, caregivers and our employees is paramount and Newron has proactively taken measures in response to the COVID-19 situation to protect all stakeholders and ensure business continuity.
  • Newron will update the market with any material developments, as appropriate.
  • Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5 mL Due to Possible Underdosing or Overdosing

Retrieved on: 
Thursday, February 20, 2020
Pharmaceutical, Health, Other Health, Drugs, Psychoactive drugs, RTT, Sodium channel blockers, Anticonvulsants, GABAA receptor positive allosteric modulators, Phenytoin, Teratogens, Pharmacy, Medical prescription, Medroxyprogesterone acetate, Ketamine

Each bottle is labeled to indicate the name of the product, Phenytoin Oral Suspension USP, 125 mg/5 mL and the NDC #51672-4069-1 (see image of container label below).

Key Points: 
  • Each bottle is labeled to indicate the name of the product, Phenytoin Oral Suspension USP, 125 mg/5 mL and the NDC #51672-4069-1 (see image of container label below).
  • Lot 327876 was distributed to wholesale distributors, long-term care providers and mail order customers in the U.S. market between July 1 and August 21, 2019.
  • These customers may have further distributed these lots to retail pharmacies for prescription dispensing to patients who were prescribed Phenytoin Oral Suspension.
  • Further updates will be detailed from time to time in the Companys SEC reports, including its Annual Reports on Form 20-F.