Early prediction of response to INP104 for the acute treatment of migraine

Presented at the AHS Annual Scientific Meeting, June 9–12, 2022

Authors: Sacco, S.; Vann, R.; Lieu, T.; Ray, S.; Shrewsbury, S.B.; Aurora, S.K.

One sentence summary: Patients who self-reported mild or no pain at 2 hours for their first 2 and first 3 INP104-treated migraine attacks were likely (>75%) and extremely likely (>89%) to be ≥75% responders over Weeks 1–24, respectively.

Background: To determine if early treatment response to INP104, dihydroergotamine mesylate (DHE) delivered nasally by Precision Olfactory Delivery (POD®) technology for the acute treatment of migraine, could predict response over consecutive migraine attacks.

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 post hoc analysis included patients with ≥4 INP104-treated migraine attacks and summarized patients who were ≥75% responders (i.e., mild or no pain at 2 hours for ≥75% of their INP104-treated migraine attacks) 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 migraine attacks during Weeks 1–4.

Results: The ≥75% response rates for Weeks 1–24 were 72.9% (51/70), 87.2% (34/39), and 94.4% (17/18) for patients with a maximum pain of none at 2 hours post-INP104 for the first, first 2, and first 3 INP104-treated migraine attacks during Weeks 1–4, respectively. The ≥75% response rates for Weeks 1–24 were 69.2% (45/65), 75.4% (52/69), and 89.1% (41/46) for patients with a maximum pain of mild at 2 hours post-INP104 for the first, first 2, and first 3 INP104-treated migraine attacks during Weeks 1–4, respectively. The ≥75% response rates for Weeks 1–24 were 35.0% (14/40), 32.6% (14/43), and 33.3% (17/51) for patients with a maximum pain of moderate at 2 hours post-INP104 for the first, first 2, and first 3 INP104-treated migraine attacks during Weeks 1–4, respectively. The ≥75% response rates for Weeks 1–24 were 8.3% (1/12), 15.0% (3/20), and 27.8% (5/18) for patients with a maximum pain of severe at 2 hours post-INP104 for the first, first 2, and first 3 INP104-treated migraine attacks during Weeks 1–4, respectively.

Conclusion: Patients who self-report mild or no pain at 2 hours for their first 3 INP104-treated migraine attacks are extremely likely (>89%) to be a ≥ 75% responder over Weeks 1–24 and those with mild or no pain for their first 2 INP104-treated migraine attacks are likely (>75%) to be a ≥75% responder over Weeks 1–24. Results suggest that if INP104 provides pain relief for the first 2–3 migraine attacks, it is likely a patient will be an INP104 responder with long-term use.