SEATTLE — Impel NeuroPharma, a Seattle-based biopharmaceutical company, received approval from the U.S. Food and Drug Administration for its novel nasal spray that treats migraine headaches.
The therapeutic, called Trudhesa, involves the use of Impel’s patented device called the POD, which sprays dihydroergotamine mesylate, or DHE, into patients’ noses more precisely so it reaches the upper nasal cavity. This part of the nose is highly vascular and allows for faster drug uptake. Impel says it is the first ever to deliver any drug to the area.
“Finally we’re delivering to patients what they need, and that is efficacy on-demand,” said Impel CEO Adrian Adams.
DHE is already approved to treat migraines via injections and intravenous infusions. Other nasal sprays with DHE exist, however, none targets the upper nasal cavity.
The problem with nasal sprays, generally speaking, is that the liquid drips down patients’ throats, said Dr. Matthew Robbins, a neurologist at Weill Cornell Medicine who is not affiliated with Impel. This limits how much is actually absorbed in the nose, and hence how fast and effective the drug can be.
With the POD’s precision and ability to reach the upper nasal cavity, Impel says it minimizes that issue.
Impel said its Phase 3 study treated 5,650 migraine attacks. Thirty-eight percent of patients experienced “pain freedom” two hours after their first dose of Trudhesa, and 66 percent experienced “pain relief.” Most patients in the first category reported remaining pain-free two days after taking the drug. The most common adverse side effect was nasal congestion, reported by nearly one in five patients.
Impel was co-founded by Seattleite John Hoekman, who has researched nasal drug delivery since college and completed a Ph.D. on the topic at the University of Washington.