Dihydroergotamine

Pulmatrix to Divest Phase 2-Ready Migraine Treatment and iSPERSE Technology Ahead of Cullgen Merger

7 days ago

• Pulmatrix plans to divest its clinical assets including PUR3100, a Phase 2-ready inhaled treatment for acute migraine, as part of its upcoming merger with Cullgen expected to close in June 2025. • The company's proprietary iSPERSE technology, which enables efficient pulmonary drug delivery with 146 granted patents, will also be divested as Pulmatrix transitions to focus on Cullgen's protein degradation platform. • First quarter 2025 financial results showed zero revenue (down from $5.9M in Q1 2024) with $7.7M cash on hand, which the company believes is sufficient to fund operations through the anticipated merger closing.

FDA Clears ZEISS INTRABEAM 700: Advanced Robotic-Assisted Platform for Intraoperative Radiotherapy

a month ago

• ZEISS INTRABEAM 700 has received FDA 510(k) clearance, offering robotic-assisted precision for intraoperative radiation therapy in neuro-oncology and breast cancer treatment. • The platform features a digital-first architecture with SMART Workflow Efficiency, including sterile single-use applicators, intuitive controls, and Radiance™ treatment planning software for pre-operative simulation. • Currently being evaluated in multiple clinical trials including INTRAGO-II for glioblastoma and TARPIT-E for breast cancer, with results expected between 2025-2027.

Dupilumab Shows Strong Efficacy in Chronic Spontaneous Urticaria Across All BMI Ranges

3 months ago

• Phase 3 LIBERTY-CSU CUPID trials demonstrate dupilumab's effectiveness in reducing itch and urticaria activity in patients unresponsive to H1-antihistamines. • Clinical benefits of dupilumab were consistent across all BMI ranges, including patients in obese categories, providing important efficacy data for diverse patient populations. • FDA review of dupilumab for chronic spontaneous urticaria is underway with a target action date of April 18, 2025, potentially offering a new treatment option for resistant cases.

FDA Rejects Satsuma's STS101 Nasal Migraine Treatment Citing Manufacturing Issues

5 months ago

• The FDA issued a complete response letter for Satsuma Pharmaceuticals' STS101, a nasal powder formulation of dihydroergotamine mesylate (DHE), due to chemistry, manufacturing, and controls (CMC) issues. • STS101 aimed to offer a portable, easy-to-use option for acute migraine, potentially improving upon existing DHE nasal sprays like Bausch Health's Migranal. • The rejection positions Satsuma behind competitors like Impel Neuropharma (Trudhesa) and Pfizer (Zavzpret) in the crowded acute migraine treatment market. • Satsuma plans to meet with the FDA to determine the timeline for resubmitting the marketing application, emphasizing that clinical data was not a concern.

FDA Gears Up for Critical Decisions on Alzheimer's, Breast Cancer, and Neurological Therapies in Early 2025

5 months ago

• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.

Migraine Treatment Advances: CGRP Inhibitors, Digital Therapeutics, and Novel Compounds Highlight 2024

5 months ago

• The American Headache Society now recommends CGRP-targeting therapies as a first-line approach for migraine prevention, marking a significant shift in treatment strategy. • Nerivio, a remote electrical neuromodulation device, received FDA approval for expanded use in pediatric patients aged 8 and older for acute migraine treatment. • Clinical trials show promise for digital therapeutic CT-132 in reducing monthly migraine days, offering a novel non-pharmacological option for episodic migraine prevention.

FDA Accepts Satsuma and SNBL's NDA Resubmission for STS101 Migraine Treatment

7 months ago

• The FDA has accepted for review Satsuma Pharmaceuticals and SNBL's resubmitted NDA for STS101, a dihydroergotamine nasal powder, for acute migraine treatment. • The PDUFA date is set for April 30, 2025, offering hope for the nearly 40 million Americans suffering from migraine, especially women in their 20s to 40s. • STS101 is designed for quick self-administration, leveraging a proprietary nasal delivery device for rapid DHE absorption and sustained plasma concentrations. • The resubmission addresses FDA's previous concerns related to formulation, with no additional clinical trials requested, marking a significant step toward potential approval.

FDA Accepts Satsuma Pharmaceuticals' NDA for STS101 Migraine Treatment

2 years ago

• The FDA has accepted Satsuma Pharmaceuticals' 505(b)(2) NDA for STS101, a novel nasal powder formulation of dihydroergotamine mesylate (DHE) for acute migraine treatment. • STS101 is designed for easy self-administration and rapid achievement of high drug plasma levels, potentially offering advantages over existing DHE products. • The NDA is supported by Phase 1 and Phase 3 trial results, including the SUMMIT trial, which demonstrated robust and sustained effects on migraine endpoints. • Satsuma Pharmaceuticals is in the process of being acquired by Shin Nippon Biomedical Laboratories, Ltd. (SNBL).

Dihydroergotamine

Drug Development Updates