An intranasal formulation of dihydroergotamine (DHE) for the acute treatment of migraine is safe and well tolerated, new research suggests.
ABOUT THE STUDY:
Initial results of the phase 3 STOP 301 trial were presented last year at the virtual annual meeting of the American Headache Society.
The additional findings were published online August 7 in Headache. Prior to the Prescription Drug User Fee Act date of September 6 for the DHE formulation known as INP104 (Impel NeuroPharma).
The open-label safety and tolerability trial included more than 300 patients who self-administered INP104 for up to 52 weeks. The results showed that 37% reported treatment emergent adverse events (TEAE) related to INP104.
Intranasal DHE: Relief of pain and absence of the most annoying symptom
However, “no new safety signals were seen” for the delivery system, the researchers note.
Furthermore, an exploratory analysis showed the efficacy of the treatment for outcomes such as pain relief and the absence of the most bothersome symptom.
“No one else has entered the upper nasal space.” So told Medscape Medical News co-investigator Sheena K. Aurora, MD. Vice President of Medical Affairs for Impel NeuroPharma, Seattle, Washington.
“We had to establish that the DHE would be safe there,” added Aurora.
Real world data
The STOP 301 trial included 354 patients with episodic migraine with or without aura. After a reference period. The patients were trained to use Precision Olfctory Delivery (POD) technology that delivers the drug into the upper nasal space.
For 24 weeks, participants self-administered INP104 using POD technology during migraine attacks. Subsequently, a subset of participants entered a 28-week continuation period of treatment.
Approximately 68% of patients reported TEAE during the 24-week period; and 36.7% reported INP104-related TEAE. The most common being nasal congestion (15%), nausea (6.8%), nasal discomfort (5.1%) and abnormal taste (5.1%). During the 52 week period, 45.2% of patients had INP104-related TEAE.
38% of patients reported absence of pain
The endoscopy results showed that the patients had no significant changes in the integrity of the olfactory mucosa. The patients also had no problems with olfactory function.
The researchers also examined exploratory results related to efficacy. Two hours after a single dose of INP104, 38% of patients reported no pain. Of this group, 7.1% reported migraine recurrence at 24 hours and 14.3% reported migraine recurrence at 48 hours.
No side effects
Approximately 52% of patients reported being free of their most bothersome symptom 2 hours after treatment. And 66.3% reported pain relief 2 hours after their first INP104-treated attack.
The phase 3 study provides real-world data comparing participants’ response to treatment with their response to their usual best care at the start of the study. Ended in Medscape Medical News Co-Investigator Stephen B. Shrewsbury, MBChB, Medical Director of Impel NeuroPharma.
The results showed that the participants “responded consistently well to the product without intolerable side effects,” he added.
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