The FDA accepts the nasal drug methyl sulfonate dehydroquinolamine (DHE) INP104

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 acute treatment of migraines.
the drug was developed using Impel's proprietary Precision Olfactory Delivery (POD) technology and delivered directly to the blood vessel-rich upper nasal cavity, potentially providing convenience and clinical benefits for 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.
FDA has set a target date of September 6, 2021 for the Prescription Drug User Charges Act (PDUFA), reflecting the standard 10-month review period and in keeping with the 505(b) (2) NDA review schedule.
If approved, INP104 will be sold under the trade name Trudhesa and will be the first and only treatment using POD technology, a new drug administration system specifically designed for blood vessel-rich upper nasal cavity.
although several treatments have been approved in recent years to treat 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 POD technology to deliver DHE to the blood vessel-rich upper nasal cavity.
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 best 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, tetanoids, and other nonstopic acute migraine drugs.
Adrian Adams, Chairman and CEO of Impel NeuroPharma, said, "The FDA's acceptance of our Trudhesa application marks another important step in our journey to bring an important new treatment option to a group of patients who, despite the latest treatment advances, still need rapid, effective, and reliable treatment options."
our proprietary POD technology has the potential to unlock the therapeutic feasibility of previously untapped therapeutic pathways (blood vessel-rich upper nasal cavity).
look forward to working closely with the FDA at the time of the review and hope that migraine patients who are still seeking non-oral and on-demand acute treatment will be able to access this option later this year.
" INP 104 regulatory application is based on the results of key open label Phase 3 study STOP301.
is one of the largest DHE longitudinal studies to date.
study, 360 adult migraine patients 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.
results reported results from
exploratory patients showed that within 2 hours of the first drug being given INP104, 66.3 percent of patients had reduced pain, 38 percent reported the disappearance of headaches, and 52 percent reported the disappearance of the most annoying migraine symptoms (MBS).
85 percent of migraine episodes reported, patients did not use rescue drugs.
16.3% of patients begin pain relief as early as 15 minutes and continue to improve over time.
, about 84% of patients reported that INP104 was easy to use and preferred to use INP104 compared to current treatments.
, most 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.
original source: Impel NeuroPharma Announces U.S. Food and Drug Administration Acceptance Of New Drug Application For INP104 For Acute Treatment Of Migraine