Impel Pharmaceuticals (NASDAQ: IMPL), a commercial-stage
biopharmaceutical company with a mission to develop transformative
therapies for people suffering from diseases with high unmet
medical needs, today announced it will present new real-world data
adding to the growing body of evidence supporting Trudhesa®
(dihydroergotamine mesylate [DHE]) nasal spray (0.725 mg per spray)
as an effective acute therapy for migraine management. The findings
will be featured in two poster presentations during the 65th Annual
Scientific Meeting of the American Headache Society (AHS), taking
place June 15-18, 2023, in Austin, Texas.
Preliminary real-world findings from an
assessment of medical and pharmacy claims data for patients with
migraine who were treated with Trudhesa in the United States
provide new evidence suggesting that concomitant preventive (with
the exception of the anti-CGRP monoclonal antibody class) and acute
medication use generally decreases in patients taking Trudhesa
between the 12-month baseline and 90-day follow-up period.
Importantly, an increase in antinausea medications was not observed
following Trudhesa use, whereas these medications are commonly used
with DHE administered intravenously.
“DHE has an established safety and efficacy
profile, often providing long-lasting relief for even the toughest
of migraine attacks. However, until Trudhesa, nasal delivery
options couldn’t reach the upper nasal space, where DHE can be
rapidly absorbed,” said Zubair Ahmed, M.D., a headache specialist
and neurologist at the Cleveland Clinic. “Trudhesa has been an
important addition to migraine care as it provides patients with
the reliable relief of DHE in a new and easy-to-use delivery
technology that can provide relief in as early as 15 minutes and,
importantly, be administered at any point during an attack. This
real-world evidence indicates that patients who respond to Trudhesa
will likely continue to respond long-term, providing an additional
benefit of potentially reducing the need for using daily oral
concomitant preventative and acute medications.”
A second poster on real-world demographic and
clinical characteristics, as well as baseline comorbidities among
patients with migraine who were treated with Trudhesa, found that
most patients were females between the ages of 36 and 45 years, and
had comorbidities that include headache syndromes other than
migraine, other neurological conditions, other pain disorders,
sleep disorders, gastrointestinal (GI) disorders, and psychiatric
disorders. In contrast to other epidemiological studies, in this
real-world patient population, GI comorbidities were more common,
which may be due to many of these patients not being able to
achieve migraine relief with oral routes of administration.
“Through our ongoing research, we continue to
find that Trudhesa has great potential for patients who don’t find
the relief they are searching for from other preventative and acute
options," said Sheena Aurora, M.D., Vice President Medical Affairs,
Impel Pharmaceuticals. "We are pleased to share these new insights
about Trudhesa use in the real-world setting with researchers and
clinicians from around the world at the AHS Annual Meeting.”
All presentations will be accessible on the AHS website
at www.americanheadachesociety.org. Following are the
presentation details of Trudhesa data being presented:
- Title: “Real-World Assessment of
Concomitant Medication Use in Patients Using INP104 in the United
States” (Poster #P-161)
- Date & Time: Friday, June 16, 12:35 –
1:50 p.m. Central Time (CT)
- Title: “Real-World Assessment of Baseline
Demographic and Clinical Characteristics Among Patients Using
INP104 in the United States” (Poster #P-160)
- Date & Time: Saturday, June 17, 12:45
– 2:00 p.m. CT
- Title: “Safety of INP104 in Migraine
Patients With Cardiovascular Risk Factors: Post Hoc Subgroup
Analysis of the Phase 3 STOP 301 Study” (Poster
#P-175)
- Date & Time: Friday, June 16, 12:35 –
1:50 p.m. CT
- Title: “Assessment of the Potential for
Drug-Drug Interactions Between INP104 and Gepants for Migraine
Management” (Poster #P-17)
- Date & Time: Friday, June 16, 12:35 –
1:50 p.m. CT
- Title: “A Cross-Sectional Survey of
Prevailing Opinions from Headache Specialists Regarding Status
Migrainosus Management” (Poster #P-04)
- Date & Time: Saturday, June 17, 12:45
– 2:00 p.m. CT
- Title: “Safety of Concomitant Triptan and
INP104 Use From the Phase 3 STOP 201 Study in Migraine Patients”
(Poster #P-174)
- Date & Time: Saturday, June 17, 12:45
– 2:00 p.m. CT
Trudhesa uses Impel’s proprietary Precision
Olfactory Delivery (POD®) technology and is the first and only
migraine nasal spray which delivers DHE – a proven,
well-established migraine therapeutic – quickly to the bloodstream
through the vascular-rich upper nasal space. Trudhesa bypasses the
gut and reduces potential absorption issues, offering rapid,
sustained, and consistent symptom relief without nausea commonly
associated with injection or infusion DHE – even when administered
hours after the onset of a migraine attack.
About MigraineApproximately 31
million adults in the U.S. are living with migraine,1 and there is
a need for more treatment options. In a survey of nearly 4,000 U.S.
patients using oral acute prescription medication for migraine, 96
percent said they were dissatisfied with at least one aspect of
their treatment—including lack of sustained relief, inconsistent
relief, and lack of relief from a rapid-onset attack. Nearly half
(48%) said they can still have pain two hours after taking
medication and 38 percent say their headache returns within 24
hours of getting relief.2 Additionally, there is a need for
non-oral routes of administration given the high prevalence of
gastrointestinal issues among people with migraine.
About Trudhesa® (dihydroergotamine
mesylate) Nasal SprayTrudhesa® is approved by the FDA for
the acute treatment of migraine with or without aura in adults in
the U.S. Using Impel’s proprietary POD® technology, Trudhesa gently
delivers DHE3—a proven, well-established therapeutic—quickly to the
bloodstream through the vascular-rich upper nasal space. Trudhesa
bypasses the gut and potential absorption issues, offering the
potential for rapid, sustained, and consistent relief without
injection or infusion, even when administered hours after the start
of a migraine attack.4
Trudhesa is a single use, drug-device
combination product containing a vial of DHE (4 mg DHE in a 1 mL
solution that is clear and colorless to faintly yellow) and a POD®
device. Prior to initiation of Trudhesa, a cardiovascular
evaluation is recommended. For patients with risk factors
predictive of coronary artery disease who are determined to have a
satisfactory cardiovascular evaluation, it is strongly recommended
that administration of the first dose of Trudhesa take place in the
setting of an appropriately equipped healthcare facility.
Trudhesa is designed to be self-administered.
Once assembled, Trudhesa should be primed before initial use by
releasing 4 sprays. A patient should use Trudhesa immediately after
priming. The recommended dose of Trudhesa is 1.45 mg administered
as two metered sprays into the nose (one spray of 0.725 mg into
each nostril). The dose may be repeated, if needed, a minimum of 1
hour after the first dose. A patient should not use more than 2
doses of Trudhesa within a 24-hour period or 3 doses within a 7-day
period. A patient should use or discard Trudhesa within 8 hours
once the vial has been opened or the product has been assembled. A
consumer assembly video is available
on www.TRUDHESA.com and please refer to the Instructions
for Use for more details.
The most common adverse reactions (incidence
≥2%) to Trudhesa were nasal congestion, nasal discomfort, nausea,
product taste abnormal, and product package associated injury. For
more information about Trudhesa and Full Prescribing
Information, including BOXED WARNING, please
visit, www.TRUDHESA.com.
About Impel Precision Olfactory Delivery
(POD®) TechnologyImpel’s proprietary POD® technology is
able to deliver a range of therapeutic molecules and formulations
into the vascular-rich upper nasal space, believed to be a gateway
for unlocking the previously unrealized full potential of these
molecules. By delivering predictable doses of drug directly to the
upper nasal space, Impel’s precision performance technology has the
goal of enabling increased and consistent absorption of drug,
overriding the high variability associated with other nasal
delivery systems, yet without the need for an injection. While an
ideal target for drug administration, to date no technology has
been able to consistently deliver drugs to the upper nasal space.
By utilizing this route of administration, Impel Pharmaceuticals
has been able to demonstrate blood concentration levels for its
investigational therapies that are comparable to intramuscular (IM)
administration and can even reach intravenous (IV)-like systemic
levels quickly, which could transform the treatment landscape for a
broad range of disorders. Importantly, the POD® technology offers
propellant-enabled delivery of dry powder and liquid formulations
that eliminates the need for coordination of breathing, allowing
for self- or caregiver-administration in a manner that may improve
patient outcome, comfort, and potentially, compliance.
About Dihydroergotamine Mesylate
(DHE)DHE was approved for the treatment of migraine in
19468 and has more than 70 years of therapeutic
use.3 Migraine treatment with DHE has demonstrated efficacy
independent of when the treatment is initiated. Unlike other
available treatments for migraine, DHE is known to bind to multiple
receptors theorized to be implicated in migraine onset and
duration.5
Trudhesa® Indication and Important
Safety InformationIndicationTrudhesa® is
used to treat an active migraine headache with or without aura in
adults. Do not use Trudhesa to prevent migraine when you have no
symptoms. It is not known if Trudhesa is safe and effective in
children.
Important Safety
Information
Serious or potentially life-threatening reductions in blood flow to
the brain or extremities due to interactions between
dihydroergotamine (the active ingredient in Trudhesa) and strong
CYP3A4 inhibitors (such as protease inhibitors and macrolide
antibiotics) have been reported rarely. As a result, these
medications should not be taken together. |
Do not use Trudhesa if you:
- Have any disease affecting your
heart, arteries, or blood circulation.
- Are taking certain anti-HIV
medications known as protease inhibitors (such as ritonavir or
nelfinavir).
- Are taking a macrolide antibiotic
such as clarithromycin or erythromycin.
- Are taking certain antifungals such
as ketoconazole or itraconazole.
- Have taken certain medications such
as triptans or ergot-type medications for the treatment or
prevention of migraine within the last 24 hours.
- Have taken any medications that
constrict your blood vessels or raise your blood pressure.
- Have severe liver or kidney
disease.
- Are allergic to ergotamine or
dihydroergotamine.
Before taking Trudhesa, tell your doctor
if:
- You have high blood pressure, chest
pain, shortness of breath, heart disease; or risk factors for heart
disease (such as high blood pressure, high cholesterol, obesity,
diabetes, smoking, strong family history of heart disease or you
are postmenopausal, or male over 40); or problems with blood
circulation in your arms, legs, fingers, or toes.
- You have or had any disease of the
liver or kidney.
- You are taking any prescription or
over-the-counter medications, including vitamins or herbal
supplements.
- You are pregnant, planning to
become pregnant or are nursing, or have ever stopped medication due
to an allergy or bad reaction.
- This headache is different from
your usual migraine attacks.
The use of Trudhesa should not exceed dosing
guidelines and should not be used on a daily basis. Serious cardiac
(heart) events, including some that have been fatal, have occurred
following the use of dihydroergotamine mesylate, particularly with
dihydroergotamine for injection, but are extremely rare.
You may experience some nasal congestion or
irritation, altered sense of taste, sore throat, nausea, vomiting,
dizziness, and fatigue after using Trudhesa.
Contact your doctor immediately if you
experience:
- Numbness or tingling in your
fingers and toes
- Severe tightness, pain, pressure,
heaviness, or discomfort in your chest
- Muscle pain or cramps in your arms
or legs
- Cold feeling or color changes in 1
or both legs or feet
- Sudden weakness
- Slurred speech
- Swelling or itching
The risk information provided here is not
comprehensive. To learn more, talk about Trudhesa with your
healthcare provider or pharmacist. The FDA-approved product
labeling can be found at www.Trudhesa.com or 1-800-555-DRUG. You
can also call 1-833-TRUDHESA (1-833-878-3437) for additional
information.
About Impel
PharmaceuticalsImpel Pharmaceuticals is a commercial-stage
pharmaceutical company developing transformative therapies for
people suffering from diseases with high unmet medical needs. Impel
offers treatments that pair its proprietary POD® technology
with well-established therapeutics. In September 2021, Impel
received U.S. FDA approval for its first product,
Trudhesa® nasal spray, which is approved in the U.S. for the
acute treatment of migraine with or without aura in adults. In
addition to Trudhesa, the Company continues to address patient
needs via licensing and partnerships.
Cautionary Note on Forward-Looking
StatementsThis press release contains “forward-looking”
statements within the meaning of the safe harbor provisions of the
U.S. Private Securities Litigation Reform Act of 1995, including,
but not limited to, the potential clinical benefits of Trudhesa®,
the market opportunities of Trudhesa within the migraine market,
the speed of uptake and market growth of Trudhesa, the
effectiveness of the Trudhesa sales force, the timing of
announcements of clinical results and clinical development
activities of Impel’s product candidates, and Impel’s cash runway.
Forward-looking statements can be identified by words such as:
“believe,” “may,” “will,” “potentially,” “estimate,” “continue,”
“anticipate,” “intend,” “could,” “would,” “project,” “plan,”
“expect” or the negative or plural of these words or similar
expressions. These statements are subject to numerous risks and
uncertainties that could cause actual results and events to differ
materially from those anticipated, including but not limited to,
Impel’s ability to maintain regulatory approval of Trudhesa, its
ability to execute its commercialization strategy for Trudhesa, its
ability to develop, manufacture and commercialize its other product
candidates including plans for future development of its POD®
devices and plans to address additional indications for which Impel
may pursue regulatory approval, whether results of preclinical
studies or clinical trials will be indicative of the results of
future trials, and the effects of COVID-19 on its clinical programs
and business operations. Many of these risks are described in
greater detail in Impel’s filings with the Securities and Exchange
Commission. Any forward-looking statements in this press release
speak only as of the date of this press release. Impel assumes no
obligation to update forward-looking statements whether as a result
of new information, future events or otherwise, after the date of
this press release.
Impel, POD, Trudhesa and the Impel logo are
registered trademarks of Impel Pharmaceuticals Inc. To learn more
about Impel Pharmaceuticals, please visit our website at
https://impelpharma.com.
Contact:
Melyssa WeibleElixir Health Public RelationsPhone: (1)
201-723-5805Email: mweible@elixirhealthpr.com
______________________________1 R. B. Lipton, M. E. Bigal, M.
Diamond, F. Freitag, M. L. Reed, W. F. Stewart. Migraine
prevalence, Disease Burden, and the Need for Preventive Therapy.
Neurology 2007;68;343-349 DOI: 10.1212/01.wnl.0000252808.97649.212
Impel Neuropharma. (2020). INP104-301. Table 3.8.2.3 Smith TR.;
Winner P.; Aurora SK.; Jeleva M.; Hocevar-Trnka J.; Shrewsbury SB.;
STOP 301: A Phase 3, Open-Label Study Of Safety, Tolerability, And
Exploratory Efficacy Of INP104, Precision Olfactory Delivery (POD®)
Of Dihydroergotamine Mesylate, Over 24/52 Weeks In Acute Treatment
Of Migraine Attacks In Adult Patients. Headache. 2021; 00: 1– 13.
https://doi.org/10.1111/head.141844 Aurora SK, et al. J Headache
Pain. 2013;14(Suppl 1):P143.5 Impel Neuropharma. (2020).
INP104-301. Table 3.3.6.
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