South Florida Sun-Sentinel (Sunday)
Company promises ‘efficacy on-demand’ with nasal spray to treat migraines
Impel NeuroPharma, a Seattle-based biopharmaceutical company, recently 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 (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 to deliver any drug to the area.
“Finally we’re delivering to patients what they need, and that is efficacy ondemand,” 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 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. “It’s almost like taking a tablet, if you’re just going to swallow the liquid that goes into the nose.”
Impel said its Phase
3 study treated 5,650 migraine attacks. Thirtyeight percent of patients experienced “pain freedom” two hours after their first dose of Trudhesa, and
66% 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 1 in 5 patients.
Migraines affect 39 million people in the U.S.,
28 million of whom are women, according to the Migraine Research Foundation.
Impel said the drug will become commercially available in October. It expects to price Trudhesa between $600 to $850 for four doses. That puts the drug at a lower price point than other comparable migraine drugs, many of which cost more than
$900.