Impel TRUDHESA™ to Provide Lifeline to Migraine Patients as Company Anticipates FDA Approval

The number of people currently living with migraine disorder is staggering. It is estimated that about 40 million people in the U.S. live with migraine and headache disorders.

These prevalent life-altering illnesses show increasing numbers even with advancements in scientific innovations, increased support and expanded research. Many people with these ailments, unfortunately, continue to also suffer in silence.

From a global perspective, the numbers even look scarier. The American Migraine Foundation estimates that 1 billion people worldwide suffer from migraines: 1 in 4 households, 1 in 5 women, 1 in 16 men and 1 in 11 children currently live with migraine and headache disorders.

It is frightening to note that migraine and headache disorders can be passed on to children. A child has a 50% chance of suffering a migraine if a parent does, and that risk increases to 75% if both parents do.

According to the Migraine Research Foundation, everyone either knows someone who suffers from migraines or struggles with migraines themselves.

• Migraine is the 3rd most prevalent and 6th most disabling illness in the world.
• Every 10 seconds, someone in the U.S. goes to the emergency room complaining of head pain, and approximately 1.2 million visits are for acute migraine attacks.
• In nearly 1 in 4 U.S. households, someone suffers from migraines.
• Amazingly, 12% of the population — including children — suffer from migraines.
• As many as 18% of American women, 6% of men and 10% of children experience migraines.
• Migraines are most common between the ages of 18 and 44.
• Migraines tend to run in families. About 90% of migraine sufferers have a family history of migraines.

Photo by Ivan Aleksic on Unsplash

About Acute Migraine

Migraine is a common and debilitating neurological disease characterized by recurrent episodes of severe head pain and associated with nausea, vomiting and sensitivity to light and sound.

While triptans account for almost 80% of migraine therapies, approximately 40% of patients do not respond adequately to triptans, and up to 79% of the patients who do respond to triptans report being dissatisfied with their current treatment and willing to try a new therapy.

Further, evidence suggests that gastroparesis, delayed emptying of the stomach, is a prevalent feature in migraines that may delay or reduce the absorption of oral medications, including Triptans, Gepants and Ditans.

Slow absorption means that acute medications can remain in the stomach for hours, delaying symptom relief, leading to loss of confidence and prolonged suffering for the current migraine attack.

These worrying figures and the side effects from drugs currently on the market call for an effective way of managing and treating migraines. After years of research and development, Impel NeuroPharma, Inc. (NASDAQ GS: IMPL) plans to release the migraine product that could have a major impact on migraine management.

Precision Olfactory Delivery® (POD®) Technology

The company, founded in Seattle in 2008 by John Hoekman, who is also the chief technology and development officer, is set to revolutionize how migraine is treated with its Precision Olfactory Delivery (POD®) technology, which has recorded impressive trial results and is currently awaiting FDA approval.

Impel NeuroPharma is a late-stage biopharmaceutical company focused on using its technology to develop transformative therapies for people suffering from diseases with high unmet needs, with an initial focus on central nervous system (CNS) disorders. The company is the first to investigate targeting the upper nasal space with optimized therapeutic molecules and formulations for treating CNS diseases.

Impel NeuroPharma's pathway to an effective treatment for migraines is built upon its proprietary POD® technology, which facilitates delivery of specific formulations of proven and effective therapeutic molecules through the upper nasal space.

Adrian Adams, chairman and CEO of Impel NeuroPharma, explained in an exclusive interview with Benzinga that Hoekman recognized many drugs were available that were delivered into the lower nasal cavity.

According to Adams, the challenge with many of those drugs was that “because of unpredictability and inconsistency in relation to dosage and delivery, you can have issues related to dripping down the back of the throat or nose, etc., which can lead to efficacy and tolerability issues.”

The POD® technology has been designed to deliver a range of therapeutic molecules and formulations deep into the vascular-rich upper nasal space. These unique combinations have the potential to deliver consistent and predictable doses of drugs, potentially enabling on-demand, at-home access for molecules previously limited to injection and hospital use.

While the technology has potential broad utility across many therapeutic areas, Impel NeuroPharma decided to focus on the CNS area and, even more specifically, combining POD® technology and dihydroergotamine (DHE), a molecule that is well known and regarded by key opinion leaders as a treatment for acute migraine.

Adams noted, however, the challenge over time has been that DHE could never be delivered predictably and consistently. "We believe that we now have the potential to deliver with this POD® technology to the upper nasal space finally what is regarded as being gold standard efficacy to a much wider patient and physician population."

Adrian Adams, Chairman and CEO of Impel NeuroPharma

Successful Trials

Impel NeuroPharma has concluded its Phase 3 Study (STOP 301 Phase 3 Study) and based on the data from the study, the company submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). It was accepted for review in January. The company now has a Prescription Drug User Fee Act (PDUFA) date of September 6. 

The company is planning for the launch of TRUDHESA™, subject to approval, in the early part of October and has already begun recruiting a 60-person sales force to market it.

The progress made by Impel NeuroPharma is good news for patients who have for years sought a reliable medical solution to migraine and headache disorders.

Adams observed that the migraine market is large and growing very strongly and by the end of 2021, the overall migraine prescription market is expected to grow more than 12%. Newer therapies like gepants and ditans in the U.S. market are key drivers of that growth.

"There are about 2 million patients in any 1 year that fail with triptans and move to the next stage of therapy, and that's where we'll be positioning TRUDHESA™."

Ease of Use

From the STOP 301 study, a high number of patients revealed that NeuroPharma's POD® device and TRUDHESA™ were easy to use. This feature of the treatment means that when patients feel a migraine coming on, they will be able to use the product and get the effects as quickly as 15 minutes with a 38% reduction in pain in 2 hours and efficacy that is sustained over a 1-year treatment.

NeuroPharma is yet to finalize up pricing for TRUDHESA™, which comes in packs of 4 doses, but Adams explained that based on feedback the company has received from payors and other groups, it could price the product between $600 and $850 for a pack of 4 doses.

"We think from a pricing perspective we can position this product in a very nice competitive way particularly bearing in mind that the vast majority of patients on TRUDHESA™ can be controlled on just 1 dose unlike a number of the gepant treatments that require a 2nd dose to get to efficacy," he said.

2nd Quarter Financial Results

Below are some highlights of the 2nd Quarter Financial Results of Impel NeuroPharma.

•       Research and Development (R&D) Expenses: Research and development expenses for the 2nd quarter of 2021 were $6.1 million, which compares with $6.8 million for the 2nd quarter of 2020. The decrease in R&D spending was due primarily to a decrease in clinical costs post the completion of the TRUDHESA™ Phase 3 trial.
•     General and Administrative (G&A) Expenses: General and administrative expenses for the 2nd quarter of 2021 were $8.9 million, which compares with $6.1 million for the 2nd quarter of 2020. The increase in G&A was due primarily to the ramp up in commercial expenses related to pre-launch activities ahead of the TRUDHESA™ launch.
•       Net Loss: For the 2nd quarter of 2021, Impel reported a net loss of $15.5 million, compared to a net loss of $13.1 million for the same period in 2020.

Read more about the financial results here.  

"I think there is, obviously, shareholder speculation ahead of the September 6 PDUFA date, so clearly between now and that date speculation is likely going to continue. We are laser-focused on executing our many pre-launch and launch activities with obvious priorities on the KOL engagement, market access and salesforce recruitment and training. We are excited about the short-, medium- and long-term prospects for Impel and the potential value-generating opportunities from shareholders that lie ahead," Adams said.

John Leaman, M.D., chief financial officer of Impel NeuroPharma, said, "There seems to be 3 areas of interest for investors including, is the TRUDHESA™ PDUFA currently on track with the FDA? We obviously can’t answer that question until September 6, but all of our discussions with the FDA appear to be the normal course of business."

Leaman continued, ”The 2nd area of interest is whether our team is ready for the commercial launch of TRUDHESA™. Adrian and our commercial team have been preparing for over the past 6 months, and we will be prepared to launch TRUDHESA™ upon a positive PDUFA from the FDA.  Finally, investors are interested in the company’s cash runway, and with our IPO and the recently announced debt financing, we now have cash runway through 2022.”

Another program in NeuroPharma's pipeline is INP105, which leverages the POD® technology and is focused on agitation and aggression in autism. The company anticipates initiating a Phase 2 proof-of-concept study in the 4th quarter and expects to have data on that in the 2nd half of 2022.

Impel NeuroPharma's 3rd program, IN107, focuses on Parkinson's disease for which dopamine is usually given orally to patients.