Poster Number-2 - Exploratory Efficacy of INP104 in Patients Using Concomitant Preventive Migraine Medications

STOP 301 was a phase 3, open-label study. 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. Patients treated migraine attacks with their best usual care during a 28-day screening period, which was followed by a 24-week treatment period in which eligible patients self-administered INP104 (1.45 mg) for self-recognized migraine attacks. eDiaries were used to collect information, both daily and with every headache or migraine, on medication used and pain or most bothersome symptom (MBS) severity through 24 weeks. Concomitant (preventive) migraine medications were permitted during the study if stable ( >30 days before screening) unless they were contraindicated for concomitant use with DHE mesylate. For this post hoc analysis, exploratory efficacy end points of self-reported pain and MBS freedom at 2 hours post-INP104 were evaluated based on concomitant preventive migraine medication groups used during the study: none, topiramate, erenumab, or other. Other included propranolol, propranolol hydrochloride, amitriptyline, onabotulinum toxin A, bupropion, Cannabis sativa, Curcuma longa, duloxetine hydrochloride, estradiol, gabapentin, ibuprofen, labetalol, lamotrigine, loratadine, magnesium, nadolol, nortriptyline, nortriptyline hydrochloride, paroxetine hydrochloride, timolol, valproate semisodium, and zonisamide. Patients who used >1 preventive medication were included under each applicable group; therefore, patients could be listed more than once. Safety outcomes based on concomitant preventive migraine medications used over 24 weeks were also evaluated.

Results:

A total of 354 patients self-administered ≥1 dose of INP104 over 24 weeks and constituted the full safety set. For this post hoc analysis, 254, 31, 7, and 29 patients used none, topiramate, erenumab, or other migraine preventive medications concomitantly at Month 0 (ie, baseline), respectively. For patients who used none, topiramate, erenumab, or other preventive medications concomitantly, the mean number of INP104-treated migraine attacks was 2.2 (n=226), 2.0 (n=20), 2.8 (n=4), and 2.4 (n=21) at Month 6 compared with 3.1 (n=292), 3.0 (n=32), 3.6 (n=7), and 3.4 (n=31) at Month 1, respectively. For patients who did not use concomitant preventive medications, self-reported pain and MBS freedom at 2 hours post-INP104 were 30.1% and 47.4% at baseline (n=254) compared with 36.1% and 53.6% at Month 6 (n=172), respectively. For patients who used topiramate concomitantly, self-reported pain and MBS freedom at 2 hours post-INP104 were 32.6% and 50.7% at baseline (n=31) compared with 31.1% and 51.7% at Month 6 (n=15), respectively. For patients who used erenumab concomitantly, self-reported pain and MBS freedom at 2 hours post-INP104 were 22.3% and 47.4% at baseline (n=7) compared with 33.3% and 41.7% at Month 6 (n=4), respectively. For patients who used other preventive medications concomitantly, self-reported pain and MBS freedom at 2 hours post-INP104 were 35.3% and 49.4% at baseline (n=29) compared with 25.3% and 38.3% at Month 6 (n=17), respectively. The incidence of treatment-emergent adverse events (TEAEs) was 73.6% (n=215), 62.5% (n=20), 42.9% (n=3), and 71.0% (n=22) for patients who used none, topiramate, erenumab, or other migraine preventive medications concomitantly over 24 weeks, respectively. The incidence of serious TEAEs was 2.1% (n=6), 0% (n=0), 14.3% (n=1), and 0% (n=0) for patients used none, topiramate, erenumab, or other migraine preventive medications concomitantly over 24 weeks, respectively. No serious TEAEs were considered related to INP104. The incidence of severe TEAEs was 4.5% (n=13), 3.1% (n=1), 14.3% (n=1), and 0% (n=0) for patients who used none, topiramate, erenumab, or other migraine preventive medications concomitantly over 24 weeks, respectively.

Conclusion:

Over 24 weeks of treatment, the exploratory efficacy of INP104 demonstrated numerical improvements in self-reported pain and MBS freedom at 2 hours post-INP104 with most of the concomitant migraine preventive groups analyzed. Safety measures were similar in patients who did or did not use concomitant migraine preventive medications over the 24-week treatment period. Results from this post hoc analysis suggest that INP104 may be an effective and well-tolerated acute medication for migraine in patients who are concurrently using preventive therapies and need effective therapy for acute episodes of migraine despite being on prevention.

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