dihydroergotamine mesylate nasal spray / Generic mfg. - LARVOL DELTA

Cardiovascular safety of dihydroergotamine mesylate delivered by precision olfactory delivery (INP104) for the acute treatment of migraine. (PubMed, Headache) - "In two separate studies, INP104 demonstrated a favorable CV safety profile when used in a study population without CV-related contraindications."

Journal • Cardiovascular • CNS Disorders • Migraine • Pain

Dihydroergotamine mesylate nasal spray: an acute treatment option for migraine in adults. (PubMed, Expert Rev Neurother) - "DHE nasal spray could be considered as rescue treatment in patients who have failed other symptomatic therapeutic strategies. Nevertheless, in the perspective of tailored therapy, the intranasal route of administration and the consequent rapid onset of action may represent benefits putatively making DHE a treatment of choice for challenging migraine attacks such as those with nocturnal onset or quickly reaching the climax of both headache and neurovegetative associated symptoms."

Journal • Review • CNS Disorders • Migraine • Pain

Efficacy and safety of intranasal agents for the acute treatment of migraine: a systematic review and network meta-analysis. (PubMed, J Headache Pain) - "Compared with other new intranasal-specific therapies in treating migraine attacks, zolmitriptan nasal spray 5 mg was the most effective agent for pain freedom at 2 h. Zavegepant nasal spray 10 mg had the fewest adverse side effects."

Journal • Retrospective data • Review • CNS Disorders • Migraine • Pain

Zavegepant (Zavzpret) for acute treatment of migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

A Phase 1 Study to Assess Safety, Tolerability, and Pharmacokinetics of PUR3100, a Novel Dry Powder Formulation of Dihydroergotamine for Oral Inhalation, in Healthy Adults. (AHS 2023) - "Overall, inhaled PUR3100 was safe and well tolerated, achieved a rapid Tmax at < 5 minutes. The Cmax and AUC of PUR3100 was linear and generally dose-proportional. The systemic exposure for all doses of PUR3100 resulted in a lower Cmax than IV DHE and in fewer treatment related TEAEs."

Clinical • P1 data • PK/PD data • CNS Disorders • Migraine • Pain

Drugs for migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Observational Analysis of the Costs Associated with Acute Treatment of Breakthrough Migraine Attacks in Medicaid Patients Using Preventive Therapies. (PubMed, Adv Ther) - "In consideration of the migraine-specific acute medications used in FFS Medicaid 2020, for patients using CGRP mAbs for prevention, medication costs may vary significantly with the number of breakthrough attacks treated per month and the type of migraine-specific acute therapy used."

Journal • Medicaid • Reimbursement • US reimbursement • CNS Disorders • Migraine

Chronic Migraine: A Narrative Review on the Use of Botulinum Toxin with Clinical Indications and Future Directions. (PubMed, J Integr Neurosci) - "For moderate/severe attacks, pharmacological therapies are triptans, dihydroergotamine nasal sprays or injections or neuroleptics, non-steroidal anti-inflammatory drugs, and corticosteroids. The established improvement with onabotulinumtoxinA treatment in CM patients had a positive impact not only in reduction monthly headache days but also in improving quality of life, with reduction in both healthcare resource utilisation (HRU) and work impairment. Aim of this review was to give an overview on the use of BoNT-A in patients with CM, giving practical advices on the clinical indications."

Journal • Review • CNS Disorders • Immunology • Inflammation • Migraine • Movement Disorders • Pain

A new dihydroergotamine nasal spray (Trudhesa) for migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine

[VIRTUAL] Reduced nausea when dihydroergotamine mesylate is delivered by INP104 (AHS 2021) - "Precision Olfactory Delivery (POD) of DHE (INP104) leads to a Cmax only ~10% that of IV DHE, but ~4-fold that of the approved MIGRANAL (Bausch Health Companies, Inc. Nausea is widely reported to occur after IV DHE administration. In the 24/52-week STOP 301 trial, pretreatment with an antiemetic was not required and less than 1% of doses of INP104 resulted in nausea, with 3 of 354 dosed patients (0.8%) withdrawing because of this TEAE. This may be due to the lower Cmax for INP104 compared to IV DHE."

CNS Disorders • Migraine

Drugs for Migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Lasmiditan (Reyvow) and ubrogepant (Ubrelvy) for acute treatment of migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine (clinicaltrials.gov) - P3; N=1201; Completed; Sponsor: Satsuma Pharmaceuticals, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Migraine

ASCEND: A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine (clinicaltrials.gov) - P3; N=300; Recruiting; Sponsor: Satsuma Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Migraine

[VIRTUAL] Patient Acceptability of a Novel Upper Nasal Delivery System for DHE – Using the Precision Olfactory Delivery Device (AHS 2020) - "A previously approved nasal DHE (Migranal) has shown variable efficacy which may be due to inconsistent absorption of DHE from the lower/anterior nasal space. Ninety percent of the patients either agreed or strongly agreed with the global question, “INP104 is easy to use”. The majority of patients reported that they found novel INP104: “easy to carry”, “allows them to return to normal activities faster than previous medication”, provides “faster and more consistent onset of effect” and results in “less recurrence than with their previous best optimal standard of care treatment”. The results bode well for INP104 and suggest upper nasal delivery may provide an effective and well tolerated alternative to acute oral treatments for migraine, yet providing the reliable efficacy of the long established DHE molecule."

Clinical • CNS Disorders • Migraine

[VIRTUAL] Safety of Dihydroergotamine for Acute Migraine Treatment: Reality vs Perception (AHS 2020) - " In the US, DHE has been used since 1945 for the acute treatment of migraine headache in a parenteral formulation (DHE45) and since 1997 as an intranasal liquid spray (Migranal). DHE is safe and well tolerated for the acute treatment of migraine in the appropriate patient population."

Clinical • CNS Disorders • Migraine

ASCEND: A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine (clinicaltrials.gov) - P3; N=300; Not yet recruiting; Sponsor: Satsuma Pharmaceuticals, Inc.; Trial completion date: Jun 2021 ➔ Oct 2021; Trial primary completion date: Apr 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Migraine

STOP 101: A Phase 1, Randomized, Open-Label, Comparative Bioavailability Study of INP104, Dihydroergotamine Mesylate (DHE) Administered Intranasally by a I123 Precision Olfactory Delivery (POD ) Device, in Healthy Adult Subjects. (PubMed, Headache) - "INP104 met the predefined statistical criteria for comparative bioavailability with IV DHE and Migranal. The shorter time to reach C and at 4 times the plasma concentration of DHE in comparison to Migranal combined with a favorable tolerability profile support further investigation of INP104 as an effective, well tolerated, and non-invasive treatment for acute episodic migraine."

Clinical • Journal • P1 data • CNS Disorders • Migraine

Reduced efficacy of sumatriptan in migraine with aura vs without aura. (PubMed) - "This post hoc analysis of pooled data from multiple randomized trials indicates that sumatriptan is less effective as acute therapy for migraine attacks with aura compared with attacks without aura. In the single study of inhaled DHE, the treatment had similar efficacy for migraine attacks with and without aura. Different responses of migraine with vs without aura to acute therapies may provide insight into underlying migraine mechanisms and influence the choice of acute therapies for different types of migraine attacks."

Journal • Biosimilar • Migraine • Pain

Leucadia Pharmaceuticals launches dihydroergotamine mesylate nasal spray (Pharmacy Times) - "Leucadia Pharmaceuticals...announced the launch of its latest first-to-market generic, Dihydroergotamine Mesylate Nasal Spray. The FDA-approved nasal spray, now available to patients, is therapeutically equivalent to Migranal® and is used for acute treatment of migraine headaches with or without aura."

Generic launch • CNS Disorders • Migraine • Pain

Pharmacokinetic Comparison of STS101, an Intranasal Dry Powder Formulation of Dihydroergotamine, with Other Intranasal, Injectable and Oral Inhaled DHE Formulations (AAN 2020) - "Design/ A literature search was performed to compare PK results of several formulations of DHE including the approved products Migranal and D.H.E.45 and the development-stage products INP104 (liquid nasal spray), MAP0004 (orally inhaled), and STS101 (nasal powder). The STS101 PK profile predicts that the acute migraine treatment goals should be achieved. Lower PK variability may lead to more consistent and reliable clinical performance. A large Phase 3 efficacy study with STS101 is ongoing to evaluate the product as an acute treatment for migraine (NCT 03901482)."

PK/PD data • CNS Disorders • Migraine

ASCEND: A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine (clinicaltrials.gov) - P3; N=300; Not yet recruiting; Sponsor: Satsuma Pharmaceuticals, Inc.

Clinical • New P3 trial • CNS Disorders • Migraine

Cipla receives USFDA final approval for dihydroergotamine mesylate nasal spray (Business Standard) - "Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (U. S. FDA) with a Competitive Generic Therapy (CGT) designation. Cipla is the first approved applicant for such CGT and, is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla's product....It is indicated for the acute treatment of migraine headaches with or without aura....Cipla's product is available for shipping immediately."

ANDA • Generic launch • CNS Disorders • Migraine • Pain

Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP-301) (clinicaltrials.gov) - P3; N=360; Completed; Sponsor: Impel NeuroPharma Inc.; Active, not recruiting ➔ Completed; Trial completion date: Oct 2019 ➔ Mar 2020; Trial primary completion date: Oct 2019 ➔ Mar 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine (clinicaltrials.gov) - P3; N=1140; Active, not recruiting; Sponsor: Satsuma Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Migraine