The Seattle Times

SEATTLE – Impel NeuroPharma, a Seattle-based biopharmaceutical company, received Food and Drug Administration approval last week for its novel nasal spray to treat migraines.

The therapeutic called Trudhesa involves the use of Impel’s patented device called POD, which more precisely sprays dihydroergotamine mesylate (DHE) into patients’ noses so that it reaches the upper nasal cavity. This part of the nose is highly vascular and allows for faster drug absorption. Impel says it will be the first drug ever delivered to the area.

DHE is already approved for the treatment of migraines through injections and intravenous infusions. There are other nasal sprays that contain DHE, but none of them target the upper nasal cavity.

The problem with nasal sprays in general is that the liquid drips down the patient’s throat, said Dr. Matthew Robbins, a neurologist at Weill Cornell Medicine who is not affiliated with Impel.

This limits how much is actually absorbed into the nose and therefore how fast and effective the drug can be.

With the precision and ability of the POD to reach the upper nasal cavity, this problem is minimized, according to Impel.

Impel said his phase 3 study treated 5,650 migraine attacks.

38% of patients experienced “pain relief” two hours after the first dose of Trudhesa, and 66% experienced “pain relief”. Most of the patients in the first category reported remaining pain-free for two days after taking the drug. The most common side effect was nasal congestion, which was reported by almost one in five patients.

Impel was co-founded by Seattleiten John Hoekman, who has been involved in nasal drug delivery since college and a Ph.D. on the subject at the University of Washington. During his thesis, Hoekman presented an idea for a nasal medication in a UW business plan competition in 2008. This idea later became Impel.

39 million people in the US have migraines, including 28 million women, according to the Migraine Research Foundation. The foundation estimates that migraines cost the US up to $ 36 billion in lost productivity annually.

Impel said the drug will be available in stores in October. Trudhesa is expected to cost between $ 600 and $ 850 for four cans.

, “Probably at the high end of that range,” said Adams. That brings the drug at a lower price than other comparable migraine medications, many of which cost more than $ 900.

The company is focused on building its sales team and believing it has insurance plans covered for Trudhesa.

Leonard Paolillo, chief commercial officer at Impel, said the company had expanded its sales team from four to 21 people this year and made offers to 60 other potential sellers that are subject to FDA approval.

“A successful launch isn’t what you do when you get to market, it’s what you do beforehand,” said Adams, who said he has been involved in 26 drugs that have received FDA approval throughout his career .

Weill Cornell Medicine’s Robbins said drug approval and adoption are two different challenges. He wants to know how well the drug is tolerated and “whether people will like it or not,” given its unique mode of action.

He also pointed out that commercial drug introductions can have additional side effects. For example, a skin patch migraine drug was withdrawn from the market in 2016 even after FDA approval because a burning sensation was not widely observed in clinical trials.

The company went public in April, raised $ 80 million, and closed a $ 50 million debt financing in July.

Impel is also developing treatments for agitation in autism patients and therapeutics for Parkinson’s disease that use the POD device with separate drugs. Trudhesa has been approved as a “combination product” that includes both the device and the drug.

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