Dihydroergotamine

Impel Pharmaceuticals Announces Filing of Voluntary Chapter 11 Cases and Signing of "Stalking Horse" Agreement to Facilitate Sale

Retrieved on: 
Wednesday, December 20, 2023

SEATTLE, Dec. 19, 2023 /PRNewswire/ -- Impel Pharmaceuticals Inc. (OTCQX: IMPL) ("Impel" or "the Company"), a commercial-stage biopharmaceutical company with a mission to develop transformative therapies for people suffering from diseases with high unmet medical needs, today announced that it is pursuing a sale of the Company and has entered into an agreement with JN BIDCO LLC to serve as the "stalking horse" bidder to acquire the Company and its assets.

Key Points: 
  • To facilitate an orderly sale process, the Company has filed voluntary petitions to commence chapter 11 proceedings in the U.S. Bankruptcy Court for the Northern District of Texas (the "Court"), which will provide interested parties the opportunity to submit higher and better offers.
  • Impel's Interim President & Chief Executive Officer, Len Paolillo, said: "After carefully reviewing all available strategic options with our advisors, Impel made the decision to pursue a sale through an in-court restructuring process.
  • Impel intends to continue operating as usual throughout the court-supervised sale process, including providing wages and benefits to employees.
  • Impel seeks to complete the sale process in the first quarter of 2024, with any sale subject to Court approval.

Impel Pharmaceuticals Announces Exploration of Strategic Alternatives

Retrieved on: 
Thursday, October 5, 2023

SEATTLE, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Impel Pharmaceuticals Inc. (NASDAQ: IMPL) (“Impel” or “the Company”), a commercial-stage biopharmaceutical company with a mission to develop transformative therapies for people suffering from diseases with high unmet medical needs, today announced that it has initiated an exploration of strategic alternatives.

Key Points: 
  • SEATTLE, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Impel Pharmaceuticals Inc. (NASDAQ: IMPL) (“Impel” or “the Company”), a commercial-stage biopharmaceutical company with a mission to develop transformative therapies for people suffering from diseases with high unmet medical needs, today announced that it has initiated an exploration of strategic alternatives.
  • As the Company explores strategic options, Impel continues to provide full commercial support behind Trudhesa, including Trudhesa Direct access support.
  • There can be no assurance that this process will result in the Company pursuing or consummating any particular transaction or other strategic outcome.
  • However, if the Company is unable to complete a transaction, it may be necessary to seek additional financing or other alternatives for restructuring and resolving its liabilities.

Pulmatrix Announces FDA Acceptance of IND Application for PUR3100 to Treat Acute Migraine

Retrieved on: 
Tuesday, September 19, 2023

BEDFORD, Mass., Sept. 19, 2023 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system diseases, today announced the U.S. Food and Drug Administration ("FDA") has accepted the PUR3100 investigational new drug ("IND") application and the Company has received a study may proceed letter for a Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Event Study to Evaluate the Safety, Tolerability, and Efficacy of PUR3100 (Dihydroergotamine Mesylate Inhalation Powder) in the Acute Treatment of Migraine. The PUR3100 formulation uses Pulmatrix's novel, proprietary dry powder delivery technology, iSPERSE™ to deliver DHE via oral inhalation using a dry powder inhaler.

Key Points: 
  • The PUR3100 formulation uses Pulmatrix's novel, proprietary dry powder delivery technology, iSPERSE™ to deliver DHE via oral inhalation using a dry powder inhaler.
  • Dr. Margaret Wasilewski, Chief Medical Officer of Pulmatrix noted, "We are pleased with the PUR3100 IND acceptance and receipt of the study may proceed letter for the Phase 2, proof of concept study.
  • The completed Phase 1 study demonstrated optimal pharmacokinetics and improved tolerability of PUR3100 compared to IV DHE.
  • We are currently pursuing options to advance PUR3100 into a Phase 2 clinical trial to investigate PUR3100 efficacy, safety, tolerability in treating acute migraine subjects."

Another Medicine to Stop Migraine in its Tracks – Zavzpret™ is Now Available, but Where will Neurologists use it?

Retrieved on: 
Thursday, August 17, 2023

Now with the July commercial availability of Zavzpret, Spherix has begun tracking its launch in the Launch Dynamix™: Zavzpret for Acute Treatment of Migraine study.

Key Points: 
  • Now with the July commercial availability of Zavzpret, Spherix has begun tracking its launch in the Launch Dynamix™: Zavzpret for Acute Treatment of Migraine study.
  • As of June, over three-quarters of physicians planned to prescribe Zavzpret to their migraine patients within the first six months of availability.
  • One way to tease apart the relative advantages and disadvantages of new migraine therapies is to utilize Spherix’s Launch Dynamix™: Zavzpret series.
  • Spherix will be tracking the awareness and perception of these investigational, pipeline therapies in its separate service, RealTime Dynamix™.

Endo Launches First Generic Version of Noxafil® (posaconazole) Injection

Retrieved on: 
Thursday, June 29, 2023

Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.

Key Points: 
  • Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.
  • Posaconazole may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism.
  • Reserve azole antifungals, including posaconazole injection, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
  • Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.

Endo Launches First Generic Version of Noxafil® (posaconazole) Injection

Retrieved on: 
Thursday, June 29, 2023

Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.

Key Points: 
  • Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.
  • Posaconazole may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism.
  • Reserve azole antifungals, including posaconazole injection, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
  • Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.

Satsuma Pharmaceuticals and SNBL Announce Three Abstracts on STS101 for the Acute Treatment of Migraine to be Presented at the American Headache Society’s 65th Annual Scientific Meeting

Retrieved on: 
Thursday, June 15, 2023

DURHAM, N.C., June 15, 2023 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. , a late-stage biopharmaceutical company currently seeking regulatory approval from the U.S. Food and Drug Administration for STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that three abstracts describing efficacy and safety results from the STS101 Phase 3 efficacy trial were selected for presentation at the American Headache Society’s (AHS) 65th Annual Scientific Meeting.

Key Points: 
  • DURHAM, N.C., June 15, 2023 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. , a late-stage biopharmaceutical company currently seeking regulatory approval from the U.S. Food and Drug Administration for STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that three abstracts describing efficacy and safety results from the STS101 Phase 3 efficacy trial were selected for presentation at the American Headache Society’s (AHS) 65th Annual Scientific Meeting.
  • The 2023 meeting will be held in a hybrid virtual and in-person format at the JW Marriott in Austin, Texas from Thursday, June 15 to Sunday, June 18, 2023.
  • Full abstracts are now available on the AHS website and will be published in the journal Headache®.
  • Sustained Efficacy of STS101 DHE Nasal Powder for the Acute Treatment of Migraine: Results from the Phase­3 Double-Blind, Randomized, Placebo-Controlled SUMMIT Study

Impel Pharmaceuticals to Present New Real-World Data for Trudhesa® at the 65th Annual Scientific Meeting of the American Headache Society

Retrieved on: 
Thursday, June 15, 2023

SEATTLE, June 15, 2023 (GLOBE NEWSWIRE) -- 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.

Key Points: 
  • 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.
  • 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.

Impel Pharmaceuticals Announces First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, May 12, 2023

SEATTLE, May 12, 2023 (GLOBE NEWSWIRE) -- Impel Pharmaceuticals Inc. (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 reported financial results for the first quarter ended March 31, 2023 and provided a business update.

Key Points: 
  • ET
    SEATTLE, May 12, 2023 (GLOBE NEWSWIRE) -- Impel Pharmaceuticals Inc. (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 reported financial results for the first quarter ended March 31, 2023 and provided a business update.
  • ET today to discuss the first quarter 2023 financial results and provide a corporate and business update.
  • A live webcast of the event will be available on the Investors section of the Impel Pharmaceuticals website at https://investors.impelpharma.com/ .
  • A replay of the webcast and accompanying slides will be available on the Impel Pharmaceuticals website following the event.

Impel Pharmaceuticals Presents New Data at AAN 2023 Suggesting Trudhesa® Nasal Spray is Safe to Use When Co-Administered With Commonly Prescribed Migraine Medications

Retrieved on: 
Wednesday, April 26, 2023

SEATTLE, April 26, 2023 (GLOBE NEWSWIRE) -- Impel Pharmaceuticals (NASDAQ: IMPL), a commercial-stage pharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, today presented results from the first-ever pharmacokinetic (PK) and pharmacodynamic (PD) evaluation of potential drug-drug interactions (DDIs) between Trudhesa® (dihydroergotamine [DHE] mesylate) nasal spray (0.725 mg per spray) and orally administered gepant medications.

Key Points: 
  • The analysis being presented suggests that no DDIs of clinical concern are theoretically predicted if Trudhesa and gepants are co-administered within recommended clinical doses.
  • Additionally, while first-pass metabolism may limit the bioavailability of orally administered drugs, since Trudhesa is administered via the upper nasal space, it bypasses the gastrointestinal (GI) and hepatic first-pass metabolism.
  • “These data suggest that Trudhesa used with some oral CGRP (calcitonin gene-related peptide) acute medications may be a safe option that warrants further study.
  • These analyses shed some light on the potential safety profile of Trudhesa when prescribed concomitantly with certain other widely used migraine therapeutics,” said Sheena Aurora, M.D., Vice President Medical Affairs, Impel Pharmaceuticals.