Development of a Rapid, Non-Addictive, Intranasal Treatment for Headache Disorders
Abstract
The primary objective of the proposed research is to accelerate development and commercialization of Relaspen, a self-administered, intranasal nerve block that provides rapid acute migraine symptom relief without the harsh and addictive side effects of existing therapeutics. The proposed development project directly addresses the Fiscal Year 2022 Peer Reviewed Medical Research Program Neuroscience Topic Area of Non-Opioid Therapy for Pain Management and is responsive to the Strategic Goal: Develop and evaluate novel treatments, including research to repurpose existing drugs, for associated neurological diseases and psychological conditions. According to the U.S. Centers for Disease Control and Prevention, 14.2% of U.S. adults report experiencing migraine symptoms within any given 3-month period, making it the second most disabling illness in the world. The prevalence of migraine in active-duty U.S. Armed Forces members has steadily increased year over year, and the Department of Veterans Affairs has reported that Veterans are more likely to experience migraine and headaches than the general U.S. population. There is strong evidence that the increased prevalence for military personnel is likely a direct result of their service. In addition to increased exposure to stressful combat situations, Service Members have higher rates of traumatic brain injury (TBI), concussion, and neck trauma, which are often followed by post-traumatic headache symptomology. For these individuals, migraine can take an immense toll on physical and emotional health, lead to missed or suboptimal training, and can reduce their return to duty rates. For Veterans, the debilitating physiological symptoms can have a broad-sweeping impact on quality of life, due to restrictions placed upon physical, emotional, occupational, academic, social, leisure, and family systems. There is no absolute cure for migraine, and 53% of active-duty Army Soldiers with migraine are prescribed last-line-of-defense butalbital and opioids within 1 year post-deployment. Relaspen technology combines a hand-held, Posterior Nasal Cavity delivery system with silicon plate spray nozzle technology to accurately deposit a novel formulation of aerosolized liquid anesthetic directly into the upper-posterior nasal cavity – without the use of propellants – to efficiently block parasympathetic signals from the sphenopalatine ganglion (SPG) associated with headache disorders. The novel combination product is the commercial translation of an SPG block procedure, which has been used in primary, specialty, and ambulatory care settings to effectively abort symptoms of severe or intractable migraines for decades. Strong clinical evidence obtained through care of patients with diagnosed headache disorders supports Relaspen’s potential for high levels of efficacy (up to 26% more effective at eliminating pain than leading prescription medications), rapid symptom relief (81% pain relief in less than 20 minutes), and feasibility of self-administration verified by end users with proof-of-concept atomizer prototypes. A complete pre-production development plan for Relaspen has been created based on industry standards (USP 601, ICH M3(R2)), regulatory guidance (21 CFR 320.1), and from our multidisciplinary development team’s clinical and industry-specific expertise. Specifically, Relaspen delivery device designs (single-button actuation, enclosure design, device positioning, storage, and safety features) will be developed through formative human factors evaluations that will bring together diverse groups of military personnel with migraine, clinical care professionals, and key opinion leaders to obtain invaluable feedback on the Relaspen concept, prototype hardware, and their expectations for ease of use in an at-home environment. Prototypes will be manufactured, optimized, and validated through benchtop and in vitro performance testing (laser diffraction and surrogate nasal cast) to ensure localiz
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310280
Entities
People
- Jonathan Beckwith
Organizations
- United States Army