Lysergamides

Satsuma Pharmaceuticals Announces Positive Pharmacokinetic, Tolerability and Safety Results From Phase 1 Trial of STS101 at Multiple Dose Strengths

Retrieved on: 
Wednesday, June 16, 2021

(Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced positive pharmacokinetic, tolerability and safety results from a Phase 1 trial of STS101.

Key Points: 
  • (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced positive pharmacokinetic, tolerability and safety results from a Phase 1 trial of STS101.
  • Based on results from this Phase 1 trial and other data, including preliminary results to date from the ongoing Phase 3 ASCEND long-term, open-label safety trial of STS101 5.2 mg, Satsuma is initiating its SUMMIT Phase 3 efficacy trial with the 5.2 mg dosage strength of STS101.
  • As previously communicated, top-line results from the SUMMIT trial are expected in the second half of 2022.
  • With the second-generation STS101 device and improved instructions-for-use, we expect subjects in SUMMIT will consistently self-administer the full DHE dose with less variability than in the previous EMERGE Phase 3 trial.

Impel NeuroPharma Announces U.S. Food & Drug Administration Acceptance Of New Drug Application For INP104 For The Acute Treatment Of Migraine

Retrieved on: 
Wednesday, January 20, 2021

INP104 is dihydroergotamine mesylate (DHE) delivered directly into the vascular-rich upper nasal space using Impel's proprietary Precision Olfactory Delivery (POD) technology.

Key Points: 
  • INP104 is dihydroergotamine mesylate (DHE) delivered directly into the vascular-rich upper nasal space using Impel's proprietary Precision Olfactory Delivery (POD) technology.
  • "Our proprietary POD technology has the potential to unlock the therapeutic viability of a previously untapped treatment pathway the vascular-rich upper nasal space.
  • Impel NeuroPharma is developing TRUDHESA with the goal to be a transformative new therapy for the acute treatment of migraine headaches.
  • IMPEL, POD and the IMPEL Logo are registered trademarks of Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma, please visit our website at http://impelnp.com .

BetterLife Closes Acquisition of Second Generation Psychedelic Assets of Transcend Biodynamics LLC

Retrieved on: 
Monday, December 21, 2020

We are excited to bring such a promising brand under the BetterLife umbrella, especially in such a fast-growing and exciting sector, said Dr. Ahmad Doroudian, CEO of BetterLife.

Key Points: 
  • We are excited to bring such a promising brand under the BetterLife umbrella, especially in such a fast-growing and exciting sector, said Dr. Ahmad Doroudian, CEO of BetterLife.
  • Transcend is a research driven biotechnology company committed to addressing unmet mental health needs through the development of patented next generation psychedelic therapeutics including the Lysergic Acid Diethylamide (LSD) derivative BOL-148.
  • BOL-148 is a nontoxic second-generation LSD-derived molecule that mimics the therapeutic potential of LSD, without the psychedelic effects or hallucinations.
  • Transcend is focused on developing second generation psychedelic compounds, peptides, pro-drugs, and nutraceuticals to address unmet needs within mental health, wellness and anti-aging industries.

BetterLife adds Next-Gen Psychedelic Therapy to its Pipeline of Drugs

Retrieved on: 
Tuesday, December 8, 2020

BOL-148 is a nontoxic second-generation LSD-derived molecule that mimics the therapeutic potential of LSD, without the psychedelic effects or hallucinations.

Key Points: 
  • BOL-148 is a nontoxic second-generation LSD-derived molecule that mimics the therapeutic potential of LSD, without the psychedelic effects or hallucinations.
  • We are thrilled to join forces with Transcend, stated Dr. Ahmad Doroudian, Chief Executive Officer of BetterLife.
  • BetterLife is already experienced in bringing innovative molecules to market and is readily poised to bring their strong clinical experience into the emerging psychedelic space.
  • Transcend is focused on developing second generation psychedelic compounds, peptides, pro-drugs, and nutraceuticals to address unmet needs within mental health, wellness and anti-aging industries.

Satsuma Pharmaceuticals to to participate in the following November Virtual Investor Conferences

Retrieved on: 
Monday, November 2, 2020

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product for the acute treatment of migraine, STS101.

Key Points: 
  • Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product for the acute treatment of migraine, STS101.
  • STS101 is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device.
  • In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be rapidly self-administered in a matter of seconds.
  • Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina.

Cipla Receives Final Approval for Generic Version of Migranal® (Dihydroergotamine Mesylate Nasal Spray 4mg/mL) With a Competitive Generic Therapy Designation

Retrieved on: 
Thursday, May 21, 2020

This 180-day CGT exclusivity will not block the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL.

Key Points: 
  • This 180-day CGT exclusivity will not block the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL.
  • Cipla's Dihydroergotamine Mesylate Nasal Spray 4mg/mL is AB-rated generic therapeutic equivalent version of Bausch Health US LLC's Migranal .
  • This is Cipla's first ANDA approval for a nasal spray.
  • According to IQVIA (IMS Health), Migranal and its authorized generic equivalents had U.S. sales of approximately $102M for the 12-month period ending March 2020.