Impel NeuroPharma said today that the FDA gave it the green light to proceed with its Phase III clinical trial of INP104 – a drug delivered by Impel’s intranasal delivery device for the treatment of acute migraine.
The company expects to start enrolling patients in the pivotal trial in the second half of this year. The study is designed to assess the safety and tolerability of long-term, intermittent use of the drug-device combination therapy.
Impel’s Precision Olfactory Device, called POD, delivers DHE to the upper nasal cavity where the drug is easily absorbed, according to the company.
“[Dihydroergotamine] is an effective, trusted cornerstone treatment for acute migraines, however current methods of administration by injection or traditional nasal spray devices have created barriers to its widespread use,” CEO Jon Congleton said in prepared remarks.
“We believe the consistent, reliable delivery of DHE via Impel’s POD intranasal device could provide a promising treatment option for both patients and their healthcare providers, and we look forward to progressing the development of INP104 as a potential acute migraine therapy,” Congleton added.