# Development of an intranasal, direct to nerve treatment for headache disorders

> **NIH NIH R43** · OLFAX, LLC · 2022 · $336,946

## Abstract

PROJECT SUMMARY
According to the US Centers for Disease Control, 14.2% of US adults report experiencing migraine symptoms within any
given 3-month period, making it the second most disabling illness in the world. Diagnosed migraine is typically categorized
as either episodic (2 – 14 days per month) or chronic (15 or more days per month), with each attack accompanied by a
combination of debilitating pain and symptoms that persist between 4 - 72 hours. There is no absolute cure for migraine,
and the overall financial burden associated with these disorders is more than $72B annually in the US and Europe. For
individuals affected, however, the personal “costs” go well beyond financial and physical pain and are reflected in
decreased relationship satisfaction, increased dependency on caregivers, and loss of work and social productivity. Despite
increased recognition of parasympathetic activation of the trigeminovascular system through the SPG, the majority of
acute migraine therapies target downstream effects of trigeminovascular activation, including CGRP receptors and 5-HT
receptors. Nonspecific pain medications used in migraine (acetaminophen, NSAIDs, opioids) may have a more direct anti-
nociceptive effect on the trigeminovascular system, but they either lack adequate potency for severe migraine symptoms
or cause significant adverse effects. Sphenopalatine ganglion (SPG) block procedures directly target the trigeminal nerve
and have been identified as an effective, in-clinic method for reducing migraine symptoms that can be administered as
often as needed without the potential for severe or addictive side effects. To date, these procedures have not been
considered a strong alternative to front-line medications due to their 1) Necessity for administration by a trained
healthcare professional, 2) Difficult and uncomfortable route of administration, and 3) High supply and procedural costs
compared to single-dose medication. In response to the increasing clinical need for alternative migraine therapies, our
team comprised of migraine care specialists, device and drug developers, and clinical research specialists has created a
technology for accurately delivering medication to the upper-posterior nasal cavity, enabling development of a self-
administered SPG block combination product that provides rapid pain relief without the harsh and addictive side effects
of existing medications. The Principal Objectives of this Phase I SBIR, separated into two distinct Aims, are to establish
technical efficacy and evaluate commercial design feasibility for self-administration – a critical component for treatment
efficacy. In the first aim, components affecting nasal spray characteristics will be designed and prototyped. Benchtop and
in vitro performance testing will be conducted using a surrogate nasal cast and laser diffraction techniques to measure
and optimize droplet size, distribution patterns, drug substance delivery rate, total drug substance delivered, and...

## Key facts

- **NIH application ID:** 10382876
- **Project number:** 1R43NS125643-01
- **Recipient organization:** OLFAX, LLC
- **Principal Investigator:** Jonathan G Beckwith
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $336,946
- **Award type:** 1
- **Project period:** 2022-08-19 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10382876

## Citation

> US National Institutes of Health, RePORTER application 10382876, Development of an intranasal, direct to nerve treatment for headache disorders (1R43NS125643-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10382876. Licensed CC0.

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