A novel delivery system
“There’s already a nasal spray on the market right now which doesn’t seem to work that well in a large number of people. This device [INP04] was designed to get the same substances to a part of the nose that’s higher and farther back, where there may be better absorption,” said Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said in an interview. Dr. Rapoport was not involved with the study.
The proprietary Precision Olfactory Delivery (POD) is meant to improve on current nasal delivery methods such as sprays, droppers, and pumps, which may deliver “less than 5% of the active drug to the upper nasal space,” according to a press release from Impel NeuroPharma.
Nasal delivery also may have advantages over oral medications. People with migraines may be more likely to have gastroparesis – delayed stomach emptying – which may affect their ability to absorb oral medications and delay symptom relief. However, patients may hesitate to agree to a medication that involves nasal delivery, Dr. Rapoport said.
“I will say it’s a little more difficult getting your patients to take a nasal spray,” Dr. Rapoport said. “Patients are used to taking tablets for their headaches,” he said. “But if the doctor spends a little more time with the patient and says, ‘Look, this could work faster for your migraine as a nasal spray. Why don’t you try it a couple of times and see if you like it or not?’ patients are usually willing to give it a try.”
The study’s limitations include the lack of a control group given that it was an open-label trial. It was carried out at 38 sites in one geographical area, which may affect the generalizability of the results. The study did not assess patients with new-onset migraine or chronic migraine.
The Food and Drug Administration approved Trudhesa on Sept. 2, 2021.
The study was funded by Impel NeuroPharma. Dr. Smith has received funding from a number of pharmaceutical companies. Dr. Rapoport disclosed no relevant financial relationships.