Impel NeuroPharma, fresh from the IPO, receives FDA approval for nasal spray for the treatment of migraines

Impel’s POD technology introduces drugs deep into the nasal cavity to treat migraine headaches. (Impell photo)

The US Food and Drug Administration has approved Trudhesa from Impel NeuroPharma for the treatment of migraine headaches, the Seattle-based company announced on Friday.

Trudhesa uses Impel’s upper nasal spray system to deliver a migraine medication into the blood and brain.

Impel expects the commercial launch of Trudhesa in early October and has begun hiring salespeople to market it.

According to the company, there are approximately 31 million adults living with migraines in the United States and many patients do not experience complete relief with existing medications.

“Pills don’t really work for a lot of patients, so there is a high unmet need,” Sheena Aurora, neurologist and vice president of medical affairs at Impel, told GeekWire this week.

Sheena Aurora, Impel Vice President for Medical Affairs. (Impell photo)

The approval is the culmination of a vision that began more than ten years ago for John Hoekman, who co-founded the company in 2008 as a doctoral student at the University of Washington in the medical device field.

“When I started the company, I never really expected to bring a product to market for patients,” said Hoekman, who served as CEO until 2017 and is now chief technology and development officer.

Impel has bypassed the traditional route of handing its product over to a larger pharmaceutical company for the final stages of clinical trials and commercialization.

It was “a huge challenge to move from a device technology company to what is now a fairly integrated pharmaceutical company,” said Hoekman. The company is led by biotech veterinarian Adrian Adams, who succeeded Jon Congleton last year.

Impel raised $ 80 million in Washington State’s first IPO in April. Shares rose to more than $ 33 in after-hours trading on Thursday overnight and then fell again on Friday, trading at around $ 20 / share.

Impel co-founder John Hoekman. (Impell photo)

As a graduate student, Hoekman studied how to deliver drugs into the upper nasal cavity, which contains a rich bed of blood vessels. Active ingredients can enter the blood and brain through the upper nose faster than conventional nasal sprays through the lower part of the nose.

Traditional nasal sprays “are fine if it’s a local rhinitis or allergy that only affects the nasal cavity,” Hoekman told GeekWire. “But for anything more, try to get it into your bloodstream or into your brain, it’s very inefficient.”

Hoekman’s graduate research eventually led to Impel’s Precision Olfactory Delivery (POD) system, which delivers drugs deep into the upper nasal cavity using an external gas fuel. “All you have to do is put it in your nose, press a button, and the drug goes where it’s supposed to go,” said Hoekman.

Trudhesa builds on a decade-old anti-migraine drug, dihydroergotamine mesylate (DHE). DHE is traditionally given via injection and there are also oral formulations that work slowly by being absorbed from the intestine and conventional spray formulations. Trudhesa delivers DHE directly into the upper nasal cavity through the POD.

The company recently published a phase 3 clinical trial involving 360 people with recurrent migraines. The study showed that Trudhesa was generally well tolerated with no serious side effects. In addition, about two thirds of the patients reported pain relief within two hours of using the spray.

In a previous study, the company also showed its system reached higher blood levels than Migranal, a DHE formulation from Bausch Health that targets the lower nasal cavity. However, there are no studies that directly compare Trudhesa’s ability to control pain to Migranal or similar generic sprays.

Hoekman said the company worked with several pharmaceutical companies in its early years, “when we were very, very small and didn’t even know what we were doing.” But those preclinical collaborations didn’t go well.

“We got a quick lesson when you rely on your partners – great as they may be – to acquire you or get a big licensing deal when something goes wrong or when they change a focus or something happens to them Economy that can collapse quickly, ”he said.

“We have decided that regardless of what others are interested in or want to work with, we will try to develop this ourselves through approval,” added Hoekman. “We always had the idea that you have to determine your own fate.”

The approval bodes well for two more agents in Impel’s pipeline. The company will initiate a phase 2 proof-of-concept study of a drug against agitation in autism later this year and expects data to be available in 2022. The second program concerns Parkinson’s disease.

Both programs use existing drugs but deliver them through Impel’s POD system for quick action. “Clinically, this opens a whole realm,” said Aurora, opening the door for future formations to get drugs to their destinations in the body faster or more conveniently.

“We have now put together a team that is essentially a small pharmaceutical company that was able to pull [Trudhesa] through the process and hopefully we will be able to do this again, ”said Hoekman.

Before going public, Impel had raised $ 140 million from investors including KKR, Norwest Venture Partners, 5AM Ventures, Vivo Capital and VenBio Partners.