Early Prediction of Response to INP104 for the Acute Treatment of Migraine

Presented at the PAINWEEK Conference, September 6-9, 2022

Authors: Sara Sacco, MD, FAHS; Robert Vann, PhD; Sutapa Ray, PhD; Stephen B. Shrewsbury, MBChB; Sheena K. Aurora, MD

Introduction: Some patients may cycle through many acute therapies for migraine before achieving adequate relief. Understanding the early prediction of response to acute therapies may help patients and clinicians optimize the acute management of migraine. INP104 is a drug-device combination product that delivers dihydroergotamine mesylate to the upper nasal space using Precision Olfactory Delivery technology. 

Objective: This post hoc analysis of data from the Phase 3, STOP 301 study of INP104 for the acute treatment to migraine aimed to determine if early treatment response to INP104 could predict response over subsequent migraine attacks (MAs).

Design/Methods: STOP 301 was a Phase 3, open-label study that assessed the safety, tolerability, and exploratory efficacy of INP104. Patients used their best usual care during a 28-day screening period and eligible patients continued into a 24-week treatment period with INP104 (1.45 mg). This analysis included patients with ≥4 INP104-treated MAs and summarized patients who were ≥75% responders (i.e mild or no pain at 2 hours for ≥75% of their INP104-treated MAs) during Weeks 1-24 by the maximum pain (i.e. none, mild, moderate, or severe) self-reported for their first, first 2 and first 3 INP104-treated MAs during Weeks 1-4.

Results: Maximum pain 2 hours post-INP104 was none in 72.9% (51/70), 87.2% (34/39), and 94.4% (17/18) or mild in 69.2% (45/65), 75.4% (52/69), and 89.1% (41/46) of patients for the first, first 2, and first 3 INP104-treated MAs during Weeks 1-4, respectively. Maximum pain was moderate (35.0% [14/40], 32.6% [14/43], 33.3% [17/51]) or severe (8.3% [1/12], 15.0% [3/20], 27.8% [5/18]) in these patients for the first, first 2, and first 3 INP104-treated MAs, respectively.

Conclusions: Patients who self-report mild or no pain at 2 hours for their first 3 INP104-treated MAs are extremely likely (>89%) to be a ≥75% responder and those with no or mild pain for their first 2 INP104 treated MAs are likely (>75%) to be a ≥75% responder.