Impel NeuroPharma Provides Updates on Trudhesa™ Launch and Recent Business Highlights
Trudhesa™ (Dihydroergotamine Mesylate) Nasal Spray for Acute Migraine Delivered Strong Q4 2021 Launch with 4,200 (TRx) Prescriptions; Exceeding Company’s Guidance Range
Achieved Broad and Favorable Trudhesa™ Payer Coverage with Signed Agreements Covering 80% of U.S. Commercial Lives
Planned Initiation of INP105 Proof-of-Concept Study for Autism Spectrum Disorder in Q1 2022; Results anticipated Q4 2022
SEATTLE, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Impel NeuroPharma (NASDAQ: IMPL), a commercial-stage pharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system, today provided updates on Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) launch progress and recent business highlights.
Trudhesa Launch Progress Update
In addition, during this first quarter of launch, the Company has secured contracts with several leading pharmacy benefit managers (PBMs) in the U.S. which cover approximately 80 percent of U.S. commercial lives.
“Last year was an exceptional year for Impel as we successfully achieved a first cycle FDA approval of Trudhesa, and raised greater than $180 million dollars through equity and debt offerings to support the successful commercialization of Trudhesa, in addition to executing a successful launch of Trudhesa in early October,” said Adrian Adams, chairman and chief executive officer of Impel NeuroPharma. “We are naturally delighted with the strong launch performance and the significant success in the managed care area, both of which exceeded our expectations. As we enter 2022, we are singularly focused on maintaining the excellent launch momentum with Trudhesa and continuing to transform Impel into a fully integrated R&D and Commercial company.”
Impel is the first company to harness the benefits of delivery to the upper nasal space to improve the therapeutic potential of CNS therapies. Using Impel’s proprietary POD® technology, Trudhesa delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic for acute migraine for adults—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 injection or infusion, even when administered hours after the onset of a migraine attack.
INP105 CALM 201 Study Update
The “CALM 201” Trial (Clinical Study in ASD Agitation with Olanzapine [INP105] Delivered to the Upper Nasal Mucosa) is a Phase 2a, proof-of concept, 2-way, 2-period crossover, double-blind study to evaluate the safety and efficacy of INP105 as an acute treatment versus placebo in people with ASD experiencing agitation. This study will evaluate the safety and tolerability of a single dose of INP105 to that of placebo in adolescents (12 to ? 18 years of age) with a diagnosis of ASD. The secondary objective is to explore the effect of treatment with a single dose of INP105 versus placebo in people with ASD experiencing agitation. It was hypothesized that INP105 could be a useful treatment for acute agitation episodes in the ASD population.
Acute agitation often manifests in patients with serious underlying mental health conditions such as bipolar I disorder or schizophrenia. Between 1.7 million and 7 million episodes of acute agitation have been reported to occur in U.S. hospitals and emergency room settings each year.1 An ideal medication for acute agitation, according to a 2005 expert consensus is easy-to-administer, non-traumatically administered, provides rapid tranquilization without excessive sedation, has a swift onset of action with sufficient duration to prevent untimely recurrence and has low risk for adverse events and drug interactions.2
Further details of the CALM201 study can be found on ClinicalTrials.gov.
Trudhesa™ Indication and Important Safety Information
Important Safety Information
Do not use Trudhesa if you:
Before taking Trudhesa, tell your doctor if:
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.
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 NeuroPharma
Cautionary Note on Forward-Looking Statements
Impel, POD and the Impel logo are trademarks of Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma, please visit our website at https://impelnp.com/.
1 The Diagnosis and Management of Agitation. Edited by Scott L. Zeller, Kimberly D. Nordstrom and Michael P. Watson. Cambridge University Press 2017, Page 1.
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