Poster Number-1 - Exploratory Efficacy of INP104 in Migraine Patients By Prior Treatment

STOP 301 was a pivotal phase 3, interventional, open-label, single-group assignment study that assessed the safety, tolerability, and exploratory efficacy of INP104. Patients were on their best usual care during a 28-day screening period (ie, baseline). Inclusion criteria included adult migraine patients with or without aura not qualifying as chronic migraine; having ≥2 migraine attacks per month for the previous 6 months and during the 28-day screening period; and being in general good health with no history of cardiovascular risk factors or diseases. Eligible patients continued into a 24-week treatment period and were provided with INP104 to nasally self-administer (1.45 mg in 2 sprays) with self-recognized migraine attacks. eDiaries were used to collect information, both daily and with every headache or migraine, on medication used and pain or MBS severity. This post hoc analysis assessed exploratory efficacy end points of self-reported pain and MBS freedom 2 hours post-INP104 administration based on acute therapies used before study initiation. Acute medications during the screening period included acetaminophen, barbiturates, combination analgesics, other ergotamine products, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, other medications, and triptans. STOP 301 was performed before the launch of gepants and ditans, and patients were included in a screening medication group if they used the medication during the 28-day screening period, so patients and their migraine attacks were counted in more than 1 group.

Results:

In total, 354 patients self-administered ≥1 dose of INP104 over 24 weeks and were included in this analysis. Most patients used acetaminophen (n=163), NSAIDs (n=139), other medications (n=121), and triptans (n=101), followed by combination analgesics (n=57), opioids (n=9), barbiturates (n=6), and other ergotamine products (n=3) during the 28-day screening period. During Weeks 1-12 and Weeks 13-24, migraine attacks self-reported as pain-free at 2 hours were 37% and 37% among acetaminophen users, 29% and 11% among barbiturate users, 41% and 31% among combination analgesics users, 90% and 50% among other ergotamine users, 36% and 34% among NSAID users, 45% and 50% among opioid users, 39% and 36% among users of other medications, and 39% and 42% among triptan users, respectively. During Weeks 1-12 and Weeks 13-24, migraine attacks self-reported as MBS-free at 2 hours were 54% and 50% among acetaminophen users, 43% and 29% among barbiturate users, 57% and 44% among combination analgesics users, 90% and 50% among other ergotamine users, 53% and 53% among NSAID users, 55% and 66% among opioid users, 54% and 54% among users of other medications, and 55% and 59% among triptan users, respectively. 

Conclusion:

Pain and MBS freedom at 2 hours post-INP104 were similar at Weeks 1-12 and Weeks 13-24 for most prior acute treatment groups. Results suggest that INP104 may be an effective acute treatment option for migraine irrespective of prior acute medication, including triptans.

References: