Teglutik (riluzole oral suspension) / Italfarmaco - LARVOL DELTA

A real-world study of riluzole oral suspension (Teglutik®) in patients with amyotrophic lateral sclerosis (ALS) (ChiCTR) - P4 | N=100 | Recruiting | Sponsor: Peking University Third Hospital; Peking University Third Hospital

New P4 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

Assessing the efficacy of amyotrophic lateral sclerosis drugs in slowing disease progression: A literature review. (PubMed, AIMS Neurosci) - "These FDA-sanctioned treatments are Qalsody, Relyvrio, Radicava, Rilutek, Tiglutik, Exservan, and Nuedexta...However, despite these advancements in pharmaceutical interventions, finding a definitive cure for ALS remains a significant challenge. Continuous investigation into ALS pathophysiology and therapeutic avenues remains imperative, necessitating further research collaborations and innovative approaches to unravel the complex mechanisms underlying this debilitating condition."

Journal • Review • Amyotrophic Lateral Sclerosis • CNS Disorders

Treatment continuity of amyotrophic lateral sclerosis with available riluzole formulations: state of the art and current challenges in a 'real-world' setting. (PubMed, Amyotroph Lateral Scler Frontotemporal Degener) - "Riluzole oral suspension (ROS) and oral film (ROF) allow riluzole intake in patients with dysphagia. ROF, the last approved formulation, requires low swallowing capacities and may contribute to maintain the efficacy of riluzole when tablets are inadequate according to patient's status and/or preferences. To optimize treatment continuity in newly diagnosed patients, the expected psychological impact of formulation switching that may be perceived as the sign of disease progression should be anticipated."

Clinical • Journal • Real-world • Real-world evidence • Review • Amyotrophic Lateral Sclerosis • CNS Disorders • Gastrointestinal Disorder • Respiratory Diseases

Tofersen (Qalsody) for ALS. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Amyotrophic Lateral Sclerosis • CNS Disorders

SK Chemicals releases Italfarmaco’s Lou Gehrig’s treatment (Korea Biomedical Review) - “SK Chemicals said it launched Italfarmaco's Teglutik Oral Suspension, a Lou Gehrig's disease treatment….Teglutic uses riluzole as an ingredient. SK Chemicals obtained item permission from the Ministry of Food and Drug Safety for the treatment's efficacy and effectiveness in prolonging the survival period of Lou Gehrig's patients...”

Launch non-US • Amyotrophic Lateral Sclerosis • CNS Disorders

Biological aspects of nitrogen heterocycles for amyotrophic lateral sclerosis. (PubMed, Appl Microbiol Biotechnol) - "Currently, the Food and Drug Administration (FDA) approved drugs such as Radicava, Rilutek, Tiglutik, Exservan, and Nuedexta to treat ALS. • Neurodegenerative diseases and their drawbacks are discussed in detail. • Recent survey of nitrogen heterocycles in treating ALS disease are highlighted."

Journal • Review • Amyotrophic Lateral Sclerosis • CNS Disorders

Administration of Riluzole Oral Suspension During the Different Stages of Amyotrophic Lateral Sclerosis. (PubMed, Front Neurol) - No abstract available

Journal • Amyotrophic Lateral Sclerosis • CNS Disorders • Gastrointestinal Disorder

Riluzole Oral Suspension: Bioavailability Following Percutaneous Gastrostomy Tube-modeled Administration Versus Direct Oral Administration. (PubMed, Clin Ther) - "In this study, riluzole oral suspension was bioequivalent when administered intragastrically and orally in healthy subjects under fasting conditions. Both administration methods were well tolerated. These results show that intragastric administration of riluzole oral suspension may provide an important formulation option in people with amyotrophic lateral sclerosis who have a percutaneous endoscopic gastrostomy tube. (Clin Ther. 2019;41:XXX-XXX)"

Journal • Amyotrophic Lateral Sclerosis • CNS Disorders • Complement-mediated Rare Disorders

ITF Pharma announces FDA approval of supplemental New Drug Application (sNDA) for Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS) with a percutaneous endoscopic gastronomy (PEG) feeding tube (PRNewswire) - "ITF Pharma...announced today that the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for TIGLUTIK® (riluzole) oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes for the treatment of amyotrophic lateral sclerosis (ALS). This supplemental new drug application (sNDA) approval expands the patient population who stand to benefit from TIGLUTIK to include individuals whose swallowing difficulty is complicated by alterations in nutritional status, necessitating the use of a PEG feeding tube."

sNDA

Motor neurons in familial ALS have mutation-specific alterations in glutamate signaling, study found (ALS News Today) - “‘In conclusion, our iPSC study showed mutation-specific alterations of glutamate receptor properties and calcium dynamics in ALS patient-derived MNs [motor neurons] that might contribute to the development of novel translational strategies with individual stratification of neuroprotective ALS therapies’…”

Biomarker • Clinical

Multidisciplinary care linked to increased survival, Spanish study shows (ALS News Today) - P=NA, N=334; “The analysis found that patients who were monitored by the multidisciplinary team were more likely to take Rilutek (88.7% vs 30.6%), as well as to initiate NIMV (47.8% vs 14.5%). They were also more likely to place a G-tube (32.9% vs 3.2%). A total 276 patients (30.7%) died during follow-up. Overall, median survival time of those treated under the multidisciplinary care model was 40 months, compared with 34 months in the group treated by a single neurologist.”

Retrospective data

Alabama Power Foundation funds research into new therapies for ALS (ALS News Today) - “Researchers doing early-stage investigation into potential new ways to halt neuron death seen in amyotrophic lateral sclerosis (ALS) have received a grant from the Alabama Power Foundation….Currently the U.S. Food and Drug Administration (FDA) has approved only three treatments to slow the progression of ALS. These are Rilutek (riluzole tablet), Tiglutik (riluzole suspension), and Radicava (edaravone).”

Financing