Recently Impel NeuroPharma Announces FDA (The Food and Drug Administration) submission of a new drug application for INP104 for the acute treatment of migraine. INP104 (dihydroergotamine mesylate) or DHE uses for the acute treatment of migraine headaches with or without aura in adult patients.
INP104 uses the Company’s proprietary Precision Olfactory Delivery (POD) technology, a novel delivery system that uniquely targets the vascular-rich upper nasal space.
Impel is focused on the development and commercialization of transformative therapies for patients living with central nervous system (CNS) disorders with high unmet medical needs and INP104 is the Company’s first therapeutic candidate to be submitted for U.S. regulatory review.
A Migraine
A migraine can cause severe throbbing pain or a pulsing sensation, usually on one side of the head. It’s often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. Migraine attacks can last for hours to days, and the pain can be so severe that it interferes with your daily activities.
For some people, a warning symptom known as an aura occurs before or with the headache. An aura can include visual disturbances, such as flashes of light or blind spots, or other disturbances, such as tingling on one side of the face or in an arm or leg and difficulty speaking.
One or two days before a migraine, you might notice subtle changes that warn of an upcoming migraine, including:
- Constipation
- Mood changes, from depression to euphoria
- Food cravings
- Neck stiffness
- Increased thirst and urination
- Frequent yawning
Researches For An Acute Migraine Treatment
The NDA (New Drug Application) submission for INP104 is supported by safety results from the pivotal Phase 3 STOP 301 study, in which over 5,650 migraine attacks were treated over 24 or 52 weeks.
Exploratory efficacy data in the FSS (n=354) observed that 66.3% of patients reported pain relief, 38% of patients reported pain freedom, and 52% had freedom from their most bothersome migraine symptom (MBS) at two hours following their first dose of INP104.
In 85% of reported migraine attacks, patients did not require rescue medication. Initial onset of pain relief as early as 15 minutes was reported by 16.3% of patients, which continued to improve over time.
- Migraine is the 3rd most prevalent illness in the world.
- Nearly 1 in 4 U.S. households includes someone with migraine.
- 12% of the population – including children – suffers from migraine.
- 18% of American women, 6% of men, and 10% of children experience migraines.
- Migraine is most common between the ages of 18 and 44.
- Migraine tends to run in families. About 90% of migraine sufferers have a family history of migraine.
- Migraine affecting 39 million men, women and children in the U.S. and 1 billion worldwide.
“The submission of INP104 represents our first NDA and marks a major milestone for Impel as we rapidly advance our pipeline of differentiated, potentially transformative therapies for people living with CNS disorders,” said Adrian Adams, chairman and chief executive officer of Impel NeuroPharma.
“Based upon the previously reported positive results of the STOP 301 study, we believe that INP104 has the potential to provide an important new option for people who need a fast, effective, and consistently reliable acute treatment of migraine headaches.”
