Associate professor of neurology, and program director, Headache Medicine Fellowship program, Medstar Georgetown University Hospital

Carrie Dougherty, MD, FAHS

“The take home message is that INP104 is delivering DHE to the upper nasal space and it's reflecting similar serum plasma levels at 20 minutes as the IV formulation but is also shown to be very tolerable.”

Data from the phase 3, open-label STOP 301 study (NCT03557333) suggest that the novel nasal delivery system of dihydroergotamine mesylate (DHE), INP104, is associated with improvements in several migraine measures with low recurrence rates and consistent efficacy throughout a 24-week stretch, as well as an acceptable safety profile. These findings were presented in several posters at the 

2021 Virtual American Headache Society (AHS) 63rd Annual Scientific Meeting

Over 52 weeks and 6332 doses of INP104, 30 patients reported 39 nausea treatment-emergent adverse events (TEAEs; 0.6% of doses). Mild nasal congestion was not uncommon (n = 59; 16.7%), but 

no concerning nasal or cardiovascular TEAEs

 Mean pain- and most bothersome symptom (MBS)-free 2-hours post-INP104 migraine attacks (MAs) ranged from 35.1% to 38.7% and 49.2% to 57.9% compared to 30.6% and 47.9% at baseline, respectively. Over 24 weeks, 25%, 57%, and 59.9% of patients were 100%, 75% or greater, and 67% or greater responders, respectively.

spoke with Carrie Dougherty, MD, FAHS, associate professor of neurology, and program director, Headache Medicine Fellowship program, Medstar Georgetown University Hospital, to learn more about the potential of INP104 to improve migraine patient care. She also discussed some challenges in treating migraine.

1. Randle L, Aurora SK, Hocevar-Trnka J, Shrewsbury SB. Reduced nausea when dihydroergotamine mesylate is delivered by INP104. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P166.
2. Craig K, Jeleva M, Hocevar-Trnka J, Aurora SK, Shrewsbury SB. Cardiovascular safety results of INP104 (POD-DHE) from the STOP 301 phase 3 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P181.
3. Davis G, Fatakia A, Pransky S, et al. Nasal safety of chronic intermittent use of INP104: Results from the phase 3 open-label STOP 301 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P182.
4. Smith TR, Aurora S, Hocevar-Trnka J, Shrewsberry S. Acute treatment of migraine with INP104: exploratory efficacy from the phase 3 STOP 301 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P180
5. Lipton RB, Nye BL, Hirman J, Shrewsbury SB, Aurora SK. Treatment consistency across multiple migraine attacks: results from the phase 3 open-label STOP 301 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract ­P183
6. Tepper SJ, Ailani J, Shrewsbury SB, Aurora SK. Recurrence rates for INP104 for the acute treatment of migraine: results from the phase 33 STOP 301 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract 179.

Videos

The program director of the Medstar Georgetown University Hospital Headache Medicine Fellowship program discussed the potential of INP104 to improve migraine patient care. 

Novel Approaches to Challenges in Treating Migraine: Carrie Dougherty, MD, FAHS

“I think there's always a treatment need for a larger patient population within migraine. We recognize migraine affects a broad range of patients. Oftentimes, acute medications are initially evaluated in the most common patient population, which is adults with episodic migraine. But I would like to see more information about this medication in adolescence.”

INP104, a novel nasal delivery system of dihydroergotamine mesylate (DHE), is associated with improvements in several migraine measures with low recurrence rates and consistent efficacy throughout a 24-week stretch, as well as an acceptable safety profile, according to data from the phase 3, open-label STOP 301 study (NCT03557333) presented in several posters at the 

One postInvestigators found that 30 patients reported 39 nausea treatment-emergent adverse events (TEAEs; 0.6% of doses) over 52 weeks and 6332 doses of INP104. Mild nasal congestion was not uncommon (n = 59; 16.7%), but 

, investigators found that mean pain- and most bothersome symptom (MBS)-free 2-hours post-INP104 migraine attacks (MAs) ranged from 35.1% to 38.7% and 49.2% to 57.9% compared to 30.6% and 47.9% at baseline, respectively. Over 24 weeks, 25%, 57%, and 59.9% of patients were 100%, 75% or greater, and 67% or greater responders, respectively.

 spoke with Carrie Dougherty, MD, FAHS, associate professor of neurology, and program director, Headache Medicine Fellowship program, Medstar Georgetown University Hospital, to learn more about further research she would like to see conducted INP104. She also discussed the history of DHE use.

The program director of the Medstar Georgetown University Hospital Headache Medicine Fellowship program discussed further research to be conducted with the nasal delivery of DHE. 

Investigating INP104 for Migraine Treatment: Carrie Dougherty, MD, FAHS

“The limitation of IV DHE is, oftentimes, the IV medication gives patients a lot of nausea as a [adverse] effect. So, in my clinic, whenever we use IV DHE, we pre-treat with anti-nausea medication to decrease that [adverse] effect profile and nausea medication often has its own constellation of [adverse] effects, so then you have 2 [adverse] effect profiles that you're dealing with.”

Recent data suggest that INP104, a novel nasal delivery system of dihydroergotamine mesylate (DHE), is associated with improvements in several migraine measures with low recurrence rates and consistent efficacy throughout a 24-week stretch, as well as an acceptable safety profile. These findings from the phase 3, open-label STOP 301 study (NCT03557333) were presented at the 

Investigators of the study found that over 52 weeks and 6332 doses of INP104, 30 patients reported 39 nausea treatment-emergent adverse events (TEAEs; 0.6% of doses). Mild nasal congestion was not uncommon (n = 59; 16.7%), but 

no concerning nasal or cardiovascular TEAEs 

, investigators also found that the mean number of migraine attacks (MAs) self-reported as pain- and most bothersome symptom (MBS)-free 2-hours post-INP104 ranged from 35.1% to 38.7% and 49.2% to 57.9% compared to 30.6% and 47.9% at baseline, respectively. In terms of consistency, over 24 weeks, 25%, 57%, and 59.9% of patients were 100%, 75% or greater, and 67% or greater responders, respectively.

spoke with Carrie Dougherty, MD, FAHS, associate professor of neurology, and program director, Headache Medicine Fellowship program, Medstar Georgetown University Hospital, to learn more about the novel Precision Olfactory Device (POD®) that INP104 employs. She discussed the advantages of the treatment compared to intravenous DHE and other currently approved DHE nasal spray formulations.

The program director of the Medstar Georgetown University Hospital Headache Medicine Fellowship program discussed the advantages of INP104 over other forms of dihydroergotamine. 

Nasal Delivery of DHE for Migraine: Carrie Dougherty, MD, FAHS 

"IV DHE has been around since the 1950s for acute treatment of migraine, and it really hasn't changed over time. The limited utility of an intravenous medication for acute migraine is most apparent in the way that you administer the medication. It's just not appropriate for patients with migraine."

Recent data from the phase 3 open-label STOP 301 study (NCT03557333) suggest that INP104, a novel nasal delivery system of dihydroergotamine mesylate (DHE), is associated with improvements in several migraine measures with low recurrence rates and consistent efficacy throughout a 24-week stretch, as well as an acceptable safety profile. Findings from the study were presented at the 

In an analysis of the full safety set, investigators of the study found that over 52 weeks and 6332 doses of INP104, 30 patients reported 39 nausea treatment-emergent adverse events (TEAEs; 0.6% of doses). While mild nasal congestion was not uncommon (n = 59; 16.7%), no concerning nasal or cardiovascular TEAEs were reported.

The investigators also looked at exploratory efficacy and found that the mean number of migraine attacks (MAs) self-reported as pain- and most bothersome symptom (MBS)-free 2-hours post-INP104 ranged from 35.1% to 38.7% and 49.2% to 57.9% compared to 30.6% and 47.9% at baseline, respectively. In terms of consistency, over 24 weeks, 25%, 57%, and 59.9% of patients were 100%, 75% or greater, and 67% or greater responders, respectively.

spoke with Carrie Dougherty, MD, FAHS, associate professor of neurology, and program director, Headache Medicine Fellowship program, Medstar Georgetown University Hospital, to learn more about the STOP 301 study data. She also detailed how INP104 compares to traditional intravenous DHE for migraine.

The program director of the Medstar Georgetown University Hospital Headache Medicine Fellowship program discussed the findings of the STOP 301 study. 

Carrie Dougherty, MD, FAHS

Articles

Novel Approaches to Challenges in Treating Migraine: Carrie Dougherty, MD, FAHS

Investigating INP104 for Migraine Treatment: Carrie Dougherty, MD, FAHS

Nasal Delivery of DHE for Migraine: Carrie Dougherty, MD, FAHS

STOP 301 Study of INP104 for Migraine: Carrie Dougherty, MD, FAHS