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October 11, 2020 // -- Impel NeuroPharma is a late-stage clinical biopharmaceutical company focused on developing and commercializing transformative therapies for patients with central nervous system (CNS) diseases with unsolved medical needs.
recently, the company announced the results of a patient report on STOP301 in the critical open label Phase 3 study of the drug INP104 at the Migraine Trust Virtual Symposium (MTIS).
INP104 is a nasal drug given to methyl sulfonate dihydroquine (DHE), which is rapidly absorbed through the upper nasal cavity and is currently being developed for the treatment of acute migraines.
the drug was developed using Impel's proprietary Precision Olfactory Delivery (POD) technology and has the potential to provide convenience and clinical benefits to patients with acute migraines.
, 66.3 percent of patients experienced pain relief within 2 hours of being given the drug, and some received pain relief within 15 minutes, according to clinical data.
inP104 is an innovative and innovative treatment for acute migraines.
INP104 is designed to optimize DHE to quickly and lastingly relieve migraines, regardless of when they are used without injection.
importantly, INP104 is designed to be dosed at a lower dose of NASal administration DHE than FDA-approved and under development research products.
this may allow patients to benefit from the established therapeutic effects of DHE without adverse side effects of lower nasal drug use.
INP104 uses Imple's propulsion POD technology to easily and consistently deliver the optimal dose of DHE to the blood vessel-rich upper nasal cavity, which is an ideal target for effective administration, especially for most migraine patients, nausea and/or vomiting during seizures, which limits the use of oral therapies, including quentin, calcitonin gene-related peptides (CGRP) inhibitors, tetanus, and other nonstopic acute migraine drugs.
three-part study, published at the Conference, 360 adult migraine sufferers were screened for 28 days, during which time they received "best routine care."
24 weeks of the study, patients were allowed to self-dosage three doses of INP104 nasal preparations (1.45 mg) per week.
, 4,515 migraines were reported in patients.
2 hours after the first insinped inP104, 38 percent of patients reported no migraines, 52 percent did not have the most annoying migraine symptoms (MBS), and 66.3 percent reported pain relief.
about 84% of patients reported that INP104 was easy to use and was more likely to use INP104 than their current treatment.
, the majority of patients (98.4%) reported no pain for 24 hours after 24 weeks of use of INP104.
the most common adverse reactions (TEAEs) during treatment were nasal congestion (15.0%), nausea (6.8%), nasal discomfort and unpleasant smells (5.1%) each, and less than 3% of all other TAAE-reported patients.
not reported serious adverse events, heart attacks or deaths related to treatment.
Stephen Shrewsbury, Chief Medical Officer, Empup NeuroPharma, M.D., said: "Although several treatments have been approved in recent years for acute migraines, there is still a need to be able to provide early and sustained remission, easy-to-use and well-to-bear acute treatments.
INP104 is the first and only product that uses our proprietary POD technology to deliver DHE to the blood vessel-rich upper nasal cavity.
the response between the safety and efficacy results from the STOP-301 study and the patient's reported results of tolerance, acceptability and exploratory efficacy is encouraging and further demonstrates that INP104 will provide a very promising treatment option for acute migraine treatment.
Origin: Impel NeuroPharma Presents Data From Pivotal Phase 3 Registration Study Of INP104 For The Treatment Of Acute Migraine At 2020 Migra Trust Virtual Symposium.