dm+d

Unassigned

New Medicines

Migraine - acute treatment

Information

New formulation
Not Known
Satsuma Pharmaceuticals

Development and Regulatory status

None
None
Pre-registration (Filed)
Sep 21Approved in US; an October launch is planned [7].
Jan 21Filed in US for acute treatment of migraine [6].
Nov 20Satsuma announces that given the STS101 efficacy signal observed in the EMERGE trial, as well as the favourable safety and tolerability profile observed to date, it is methodically analysing EMERGE trial data in order to understand the reasons for the trial outcome and to inform decisions regarding potential plans to advance development of STS101. It anticipates providing an update on business plans by early 2021 after completing the analyses [5].
Aug 20FDA filing anticipated 2021 Q4 [2].

Category

Serotonin receptor agonist
Migraine affects 18% of women and 6% of men [1].
Migraine - acute treatment
Intranasal

Trial or other data

Sep 20In the PIII EMERGE trial, there were no statistically significant differences between either dosage strength of STS101 and placebo on co-primary endpoints of freedom from pain and most bothersome symptom at two hours post-administration. Further analyses of the EMERGE trial data are ongoing, and Satsuma expects to provide a more detailed update on its business plans after these analyses are completed. Although topline data showed numerical differences in favor of STS101 3.9mg and 5.2mg versus placebo on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia and nausea) at two hours post-administration, these differences did not achieve statistical significance for either dosage strength. Both dosage strengths of STS101 did, however, demonstrate significant effects on both freedom from pain and most bothersome symptom by three hours post-dose and later time points. Both STS101 dosage strengths were well-tolerated, with low adverse event rates and no serious adverse events reported [4].
Aug 20PIII, double-blind RCT (EMERGE, NCT03901482) has enrolled 1140 adult patients with migraine into one of three arms (low dose, high dose, placebo). Primary outcome measures are pain freedom at 2 hours and freedom from most-bothersome symptoms at 2 hours. Secondary outcomes are sustained pain freedom, use of rescue medication and pain relapse. Topline results are expected in September or October 2020 [3].
Aug 20Open-label, PIII ASCEND trial (NCT04406649) was initiated to evaluate safety and tolerability of dihydroergotamine nasal powder as an acute treatment of migraine (used on an as needed basis). The intention is to enrol 300 patients and allocate to one of two treatment arms (low dose vs. high dose). Primary completion expected October 2021 [2,3].