Mexiletine

Mexiletine's Path to Treating Myotonic Dystrophy: A Comprehensive Drug Insight, 2023-2032

Retrieved on: 
Friday, July 28, 2023
Health, Pharmaceutical, EU4, Delayed onset muscle soreness, ODD, Contract management, B cell, Research, Movement, Disaster medicine, Mexiletine, US, SWOT, Myotonia, Patient, United Kingdom, FDA, Pharmaceutical industry, Myotonic dystrophy

This report offers a comprehensive overview of mexiletine's potential in treating Myotonic Dystrophy across the seven major markets.

Key Points: 
  • This report offers a comprehensive overview of mexiletine's potential in treating Myotonic Dystrophy across the seven major markets.
  • Notably, the US FDA has granted mexiletine Orphan Drug Designation (ODD) for the treatment of Myotonic Dystrophy.
  • The report offers comprehensive insights into mexiletine for Myotonic Dystrophy, encompassing a detailed product overview, its mechanism of action, dosage and administration, and ongoing research and development activities related to Myotonic Dystrophy.
  • Additionally, it offers a comprehensive overview of late-stage emerging therapies for Myotonic Dystrophy, along with a SWOT analysis featuring analyst views for mexiletine in Myotonic Dystrophy.

Lupin and Exeltis Announce Reimbursement Approval of NaMuscla® in Spain for the Symptomatic Treatment of Myotonia in Adults with non-dystrophic myotonic (NDM) Disorders

Retrieved on: 
Monday, January 9, 2023
Disease, News, Myotonia, NDM, Lupinus, Degenerative disease, National Health, Quality of life, Safety, Neuromuscular Disorders, Patient, Prevalence, Mexiletine, Investment, Health insurance, Pharmaceutical industry, Renewable energy, EU

NaMuscla® is the first and only licensed product for this indication in Europe and will be commercialized by Lupin’s partner Exeltis in Spain.

Key Points: 
  • NaMuscla® is the first and only licensed product for this indication in Europe and will be commercialized by Lupin’s partner Exeltis in Spain.
  • NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain1, and is characterized by the inability to relax muscles following voluntary contraction (myotonia).
  • NaMuscla® reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients2.
  • We are grateful to all stakeholders involved in the approval process, especially our partner Exeltis,” said Thierry Volle, President EMEA, Lupin.

Aquestive Therapeutics and Haisco Pharmaceutical Group Enter Licensing and Supply Agreement for Riluzole Oral Film for ALS Treatment in China

Retrieved on: 
Thursday, March 3, 2022
Purging disorder, Security (finance), Degenerative disease, Neutropenia, Urine, Enoxacin, U.S. Securities and Exchange Commission, Tongue, Hypertension, ALS, CYP1A2, News, FDA, Therapy, Drug development, Anaphylaxis, LinkedIn, Company, Development, Food, Caregiver, Jaundice, Water, Methoxsalen, Tablet, Vomiting, Fluvoxamine, Cough, Clobazam, Nausea, Fatigue, CNS, Fever, Mexiletine, Tiabendazole, Seizure, Riluzole, NASDAQ, Allergy, Lennox–Gastaut syndrome, Viscosity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, HIV disease progression rates, Liver, Central nervous system, Safety, Weakness, Abdominal pain, Vemurafenib, SZSE, Hepatotoxicity, Ciprofloxacin, GLOBE, Amyotrophic lateral sclerosis, Pharmaceutical industry

Around 85% of ALS patients suffer from a progressive loss of bulbar functionality.1 Swallowing food and liquids becomes more difficult over time.

Key Points: 
  • Around 85% of ALS patients suffer from a progressive loss of bulbar functionality.1 Swallowing food and liquids becomes more difficult over time.
  • This agreement with Haisco will allow ALS patients in China to access EXSERVAN, a riluzole oral film, which will provide a meaningful treatment option to those who have to discontinue their treatment because of difficulties swallowing a tablet.
  • Pursuant to the agreement, Haisco will lead the regulatory and commercialization activities for EXSERVAN in China.
  • EXSERVAN, an oral film formulation of riluzole, was developed by Aquestive using its PharmFilminnovative drug delivery technology.

Lupin Signs Distribution Agreement with Medis for Orphan Drug NaMuscla®

Retrieved on: 
Wednesday, February 9, 2022
Prevalence, Pain, Blinking, Lupinus, CEE, Awareness, Time, Research, Prescription, Company, CNS, API, Eating, Ion, Quality of life, EMEA, LATAM, Knowledge, Patient, Sodium, Diagnosis, Biotechnology, Central nervous system, CEO, Facial muscles, NDM, Cramp, Walking, APAC, Neuromuscular Disorders, Disease, Mexiletine, Pharmaceutical industry, Myotonia, Medis, EU

Mumbai, Zug, February 09, 2022: Global pharma major, Lupin Limited (Lupin) announced today that it has entered into a distribution agreement with Medis for Lupins orphan drug NaMuscla(mexiletine).

Key Points: 
  • Mumbai, Zug, February 09, 2022: Global pharma major, Lupin Limited (Lupin) announced today that it has entered into a distribution agreement with Medis for Lupins orphan drug NaMuscla(mexiletine).
  • Medis will commercialize NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in Central and Eastern European countries.
  • NaMuscla, which has been designated orphan drug status, received EU marketing authorization in December 20182.
  • The distribution agreement represents an important milestone for Lupin as we continue the roll out of NaMuscla across Europe.

Senores Pharmaceuticals, Inc. announces the launch of Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg and 250 mg with one of the top generic pharmaceutical companies in the U.S. market

Retrieved on: 
Thursday, January 27, 2022
Judgement, USP, Mexiletine, USFDA, Ventricular tachycardia, Arrhythmia, Generic drug, Pharmaceutical industry

ATLANTA, Jan. 27, 2022 /PRNewswire/ --Senores Pharmaceuticals, Inc.announced the launch of Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg and 250 mg, a therapeutic equivalent version of MEXITIL (Mexiletine Hydrochloride) with one of the top 5 generic pharmaceutical companies in the U.S. market.

Key Points: 
  • ATLANTA, Jan. 27, 2022 /PRNewswire/ --Senores Pharmaceuticals, Inc.announced the launch of Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg and 250 mg, a therapeutic equivalent version of MEXITIL (Mexiletine Hydrochloride) with one of the top 5 generic pharmaceutical companies in the U.S. market.
  • Mexiletine Hydrochloride Capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening.
  • "We are thrilled to announce the commercial launch of Mexiletine Hydrochloride Capsules in the U.S. market," stated Dhananjay Barot, Director, Senores Pharmaceuticals, Inc. "Our unwavering commitment towards the pharmaceutical industry makes us a prominent supplier for this product," stated Swapnil Shah, Managing Director, Senores Group.
  • Senores Pharmaceuticals, based in Atlanta, Georgia is one of the fastest-growing pharmaceutical companies in the U.S. market.

Lupin’s Namuscla® (mexiletine) is recommended by NICE for treatment of symptomatic myotonia in adults with non-dystrophic myotonic disorders (NDM)

Retrieved on: 
Thursday, November 4, 2021
Online, Safety, Mexiletine, Neurology, Lupinus, Weakness, Biotechnology, Diagnosis, Disease, Abdominal pain, Channelopathy, JAMA, CNS, Ioan Horga, NDM, EMA, Patient, Product, Myalgia, Ion, Relaxation, Cramp, Eating, Time, Vertigo, Prescription, Adult, Randomized controlled trial, Company, Fatigue, Pain, API, LATAM, Brain, Central nervous system, Neuromuscular Disorders, Sütterlin, Insomnia, Veni, vidi, vici, Sodium, Medical imaging, Fine chemical, Pharmaceutical industry, Legume

The major clinical manifestation of the non-dystrophic myotonias is muscle stiffness as a consequence of the myotonia-delayed muscle relaxation after voluntary contraction.

Key Points: 
  • The major clinical manifestation of the non-dystrophic myotonias is muscle stiffness as a consequence of the myotonia-delayed muscle relaxation after voluntary contraction.
  • Myotonia can severely affect different parts of the body, with pain, weakness and fatigue being the main symptoms, among others, that accompany the disease.
  • Although not life limiting, patients with non-dystrophic myotonia can experience significant lifetime morbidity due to stiffness and pain related to myotonia.
  • Patients may perceive that myotonia increases in severity over time, impacting daily life.

Scottish Medicines Consortium approves Lupin's NaMuscla® (mexiletine) to treat symptomatic myotonia in adults with non-dystrophic myotonic disorders (NDM)

Retrieved on: 
Tuesday, December 8, 2020
Organ systems, Rare diseases, Channelopathies, Clinical medicine, Medical specialties, Myotonia, Myotonia congenita, Mexiletine

The major clinical manifestation of the non-dystrophic myotonias is muscle stiffness as a consequence of the myotonia- delayed muscle relaxation after voluntary contraction.

Key Points: 
  • The major clinical manifestation of the non-dystrophic myotonias is muscle stiffness as a consequence of the myotonia- delayed muscle relaxation after voluntary contraction.
  • Although not life limiting, patients with non-dystrophic myotonia can experience significant lifetime morbidity due to stiffness and pain related to myotonia.
  • Patients may perceive that myotonia increases in severity over time, impacting daily life.
  • Mexiletine for symptoms and signs of myotonia in nondystrophic myotonia: a randomized controlled trial.

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.