Trudhesa™ (Dihydroergotamine Mesylate) Nasal Spray for Acute Migraine Delivered Strong Q4 2021 Launch with 4,200 (TRx) Prescriptions; Exceeding Company’s
Achieved Broad and Favorable Trudhesa™ Payer Coverage with Signed Agreements Covering 80% of
Planned Initiation of INP105 Proof-of-Concept Study for Autism Spectrum Disorder in Q1 2022; Results anticipated Q4 2022
Trudhesa Launch Progress Update
Since the
In addition, during this first quarter of launch, the Company has secured contracts with several leading pharmacy benefit managers (PBMs) in the
“Last year was an exceptional year for Impel as we successfully achieved a first cycle FDA approval of Trudhesa, and raised greater than
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
Impel continues to advance its combination product candidate, INP105, an intranasal olanzapine product (a widely used atypical, second-generation antipsychotic) being developed as an acute treatment for agitation in persons with autism spectrum disorder (ASD) via Impel’s POD® technology. Since filing the investigational new drug (IND) application in November of last year, the Company has been working with the
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
Further details of the CALM201 study can be found on ClinicalTrials.gov.
About INP105
INP105 is an upper nasal formulation of olanzapine administered using Impel’s novel POD® technology and being developed for the potential treatment of agitation and aggression associated with ASD. The POD is a novel, simple-to-use device designed to deliver consistent and predictable doses of drug. INP105 delivers olanzapine to the richly vascularized upper nasal space to offer rapid, consistent, and optimized bioavailability that can be administered by the patient or a caregiver. Olanzapine is the most used treatment for acute agitation, but its use is limited to intramuscular injection and in a hospital setting. INP105 is intended to be a preferred choice for the safe and rapid treatment of acute agitation and, because it is designed to be non-invasive, it has the potential to expand the treatment setting beyond the emergency room, such as inpatient treatment or community care facilities and the patient’s home.
About Migraine
Approximately 31 million adults in the
Trudhesa™ Indication and Important Safety Information
Indication
Trudhesa™ 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
Cautionary Note on Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the
Impel, POD and the Impel logo are trademarks of
Contact:
Media Relations:
Elixir Health Public Relations
Phone: (1) 201-723-5805
Email: mweible@elixirhealthpr.com
Investor Relations
Stern Investor Relations
Phone: 212-362-1200
Email: christina.tartaglia@sternir.com
________________________________
1 The Diagnosis and Management of Agitation. Edited by
2 Allen MH, Currier GW, Hughes DH et al. J Psychiatr Pract 2005. 11(Suppl 1); 5-108
3
4
Source:
2022 GlobeNewswire, Inc., source