Amisulpride

Eagle Pharmaceuticals to Present Abstract on Post-hoc Analysis of Amisulpride at the 77th PGA (PostGraduate Assembly in Anesthesiology) in New York City

Retrieved on: 
Wednesday, December 6, 2023
Science, Food, Amisulpride, Nausea, MD, Incidence, PONV, Patient, Vomiting, CMS, Pharmaceutical industry

-- Unique J-code for Barhemsys (J-0184) from CMS effective on January 1, 2024 --

Key Points: 
  • The conference is sponsored by the New York State Society of Anesthesiologists and is a global platform for presenting anesthesia’s latest science and technologies.
  • “PONV contributes to prolonged post-anesthesia care unit and hospital stays and is distressing to patients and healthcare providers,” stated Mike Greenberg, MD, Vice President of Medical Affairs at Eagle Pharmaceuticals.
  • This analysis details pooled data on nausea-related outcomes from two Phase III trials.
  • We believe Barhemsys presents an opportunity for a much-needed therapeutic option for these patients,” concluded Dr. Greenberg.

Eagle Pharmaceuticals Granted Unique J-Code and Pass-Through Status for BARHEMSYS® from CMS

Retrieved on: 
Monday, October 23, 2023
FDA, Level 2, Amisulpride, Therapy, Government, Vomiting, MD, Medicare Advantage, PONV, Senior, Centers for Medicare & Medicaid Services, Healthcare Common Procedure Coding System, Interim, Hospital, Patient, Health insurance, Pharmaceutical industry, Medicare, Eagle

WOODCLIFF LAKE, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that Centers for Medicare & Medicaid Services (“CMS”) has established a unique, product-specific billing code and granted transitional pass-through payment status for Barhemsys (amisulpride) injection. The new Healthcare Common Procedure Coding System (“HCPCS”) Level II code (“J-code”) is J-0184 “Injection, amisulpride, per 1 mg” and will be effective on January 1, 2024, replacing the C-code (C-9153), which will be discontinued. Beginning October 1, 2023, Barhemsys became eligible for separate reimbursement outside of the surgical bundled payment in both the ambulatory surgery center (“ASC”) and hospital outpatient department (“HOPD”) care settings.

Key Points: 
  • -- J-code is effective January 1, 2024, and transitional pass-through status became effective October 1, 2023, facilitating patient access --
    WOODCLIFF LAKE, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that Centers for Medicare & Medicaid Services (“CMS”) has established a unique, product-specific billing code and granted transitional pass-through payment status for Barhemsys (amisulpride) injection.
  • Beginning October 1, 2023, Barhemsys became eligible for separate reimbursement outside of the surgical bundled payment in both the ambulatory surgery center (“ASC”) and hospital outpatient department (“HOPD”) care settings.
  • “Receiving pass-through status, as well as a J-code, is an ideal combination that will facilitate patient access to this important therapeutic,” stated Scott Tarriff, President and Chief Executive Officer of Eagle.
  • The granting of pass-through status helps streamline the reimbursement process and facilitates patient access to Barhemsys.

LB Announces Publication of Phase 1 Clinical Study of LB-102

Retrieved on: 
Tuesday, July 19, 2022
Research, Technology, Other Technology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Lists of diseases, Schizophrenia, Half-life, Amisulpride, Patient, Pharmacokinetics, Plasma, Safety, BID, Trial of the century, CNS, Human, LB, Dopamine, Pharmaceutical industry, Psychopharmacology, PANSS

The article, titled "A randomized, double-blind, placebo controlled, phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of LB-102, a selective dopamine D2/3/5-HT7 inhibitor" (Biernat et al.

Key Points: 
  • The article, titled "A randomized, double-blind, placebo controlled, phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of LB-102, a selective dopamine D2/3/5-HT7 inhibitor" (Biernat et al.
  • LB-102 is being developed by LB as a potential treatment for schizophrenia and other psychiatric disorders.
  • This clinical study enrolled 64 healthy volunteers and was the first time LB-102 had been dosed in humans.
  • Based on these encouraging data, as well as data from a subsequent clinical study of dopamine receptor occupancy using positron emission tomography, LB is planning a Phase 2 clinical study of LB-102 in patients with acute exacerbated schizophrenia.

LB Announces Presentation of Full Results of Dopamine Receptor Occupancy Study of LB-102 at the 2021 ACNP Conference

Retrieved on: 
Tuesday, December 7, 2021
Mental Health, Health, Science, Pharmaceutical, Research, PET, N, Neurology, Pharmacokinetics, Dopamine, Safety, Schizophrenia, Plasma, Patient, CEO, PK, American College, Neuroscience, George Washington University School of Medicine & Health Sciences, LB, MD, RO, CNS, Trial of the century, Washington University in St. Louis, Intellectual property, Radiology, Amisulpride, Doctor of Philosophy, Pharmaceutical industry

The presentation, titled PET clinical study of novel antipsychotic LB-102 demonstrates unexpectedly prolonged dopamine receptor engagement, described results from a PET study designed to evaluate striatal dopamine receptor occupancy (RO) in healthy human subjects.

Key Points: 
  • The presentation, titled PET clinical study of novel antipsychotic LB-102 demonstrates unexpectedly prolonged dopamine receptor engagement, described results from a PET study designed to evaluate striatal dopamine receptor occupancy (RO) in healthy human subjects.
  • As a comparison, 400 mg of amisulpride are required to achieve the 70% dopamine RO 50 mg LB-102 afforded.
  • A double-blind, placebo-controlled, Phase 2 clinical study of LB-102 in schizophrenia patients is expected to begin in the first half of 2022.
  • A first-in-human, double-blind, placebo-controlled, Phase 1 clinical of LB-102 study designed to test the safety and pharmacokinetics of LB-102 was completed in 2020, and a second clinical study evaluating dopamine receptor occupancy of LB-102 was completed in 2021.

LB Pharmaceuticals Presents Results of Dopamine Receptor Occupancy Studies of LB-102 at ECNP Conference

Retrieved on: 
Monday, October 4, 2021
Research, Technology, Other Technology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, CNS, Mouse, PET, European College of Neuropsychopharmacology, Amisulpride, RO, Pharmacokinetics, ECNP, Patient, CEO, Trial of the century, Human, Brain, Safety, Intellectual property, Schizophrenia, Pharmaceutical industry

LBs presentation included results from PET studies designed to evaluate striatal dopamine receptor occupancy (RO) in mice and in healthy human subjects.

Key Points: 
  • LBs presentation included results from PET studies designed to evaluate striatal dopamine receptor occupancy (RO) in mice and in healthy human subjects.
  • In mice, dopamine RO of LB-102 was double that of amisulpride at the same dose.
  • Doses used in this study were a fraction of published doses of amisulpride required to reach a similar dopamine RO.
  • We believe that results from these PET studies establishes proof of concept that LB-102 will be an effective treatment for schizophrenia.

Sunovion, Sumitomo Dainippon Pharma and Otsuka Enter Worldwide Development and Commercialization Collaboration

Retrieved on: 
Thursday, September 30, 2021
Mental Health, Health, Managed Care, Clinical Trials, Pharmaceutical, Biotechnology, Lists of diseases, Regulation of tobacco by the U.S. Food and Drug Administration, Neuropsychiatry, Program, Growth, Pharmacology, Creativity, Psychology, Investment, Bipolar I disorder, Sumitomo Dainippon Pharma, Food, Amisulpride, Health, Mental disorder, Commercialization, Depression, Multimedia, LinkedIn, Heart, Twitter, Medicine, Science, Facebook, Maintenance, Global Burden of Disease Study, Dementia, Internet, USD, Solution, FDA, Neurology, World Health Organization, YouTube, Â, Disease burden, Brain, Agitation, TAAR1, Education, Tuberculosis, SUNOVION, WHO, Patient, Sunovion, Algorithm, Psychiatry, Research, Schizophrenia, Fine chemical, Pharmaceutical industry, Sunovion Compounds, Neuropsychiatric Disorders, Sunovion, Sumitomo Dainippon Pharma, SUNOVION COMPOUNDS, NEUROPSYCHIATRIC DISORDERS, SUNOVION, SUMITOMO DAINIPPON PHARMA

Sunovion Pharmaceuticals Inc. (Sunovion),its parent company Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the companies have entered into a worldwide license agreement for the joint development and commercialization of four compounds: ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135.

Key Points: 
  • Sunovion Pharmaceuticals Inc. (Sunovion),its parent company Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the companies have entered into a worldwide license agreement for the joint development and commercialization of four compounds: ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135.
  • Sumitomo Dainippon Pharma aims to achieve sustained growth through global collaboration in anticipation of future changes in the business environment.
  • Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide.
  • SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
    Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
    2021 Sunovion Pharmaceuticals Inc. All rights reserved.

LB Pharmaceuticals To Participate in the B. Riley Securities’ Neuroscience Conference

Retrieved on: 
Monday, April 26, 2021
Research, Technology, Other Technology, Clinical trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Psychoactive drugs, Chemical compounds, Atypical antipsychotics, Receptor antagonists, Pyrrolidines, Amisulpride, Antidepressants, Antiemetics, Sulpiride, Placebo-controlled study

Following the presentation, Mr. Prensky will participate in a question-and-answer session.

Key Points: 
  • Following the presentation, Mr. Prensky will participate in a question-and-answer session.
  • Our approach is to create a research-focused organization dedicated to generating novel intellectual property around improved versions of these former best-selling drugs.
  • LB-102 has the potential to offer schizophrenia patients the benefits of amisulpride at a lower dose than amisulpride.
  • A first-in-human, double-blind placebo-controlled Phase 1 study designed to test the safety and pharmacokinetics of LB-102 was completed over the summer of 2020.

LB Pharmaceuticals Announces the Initiation of Patient Dosing in Open Label Phase 1b Imaging Study of LB-102

Retrieved on: 
Tuesday, February 2, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical trials, Psychoactive drugs, Drugs, Receptor antagonists, Atypical antipsychotics, Pyrrolidines, Antidepressants, Amisulpride, Antiemetics, Dopamine, Positron emission tomography, Sulpiride, Management of schizophrenia, LB-102, LB Pharmaceuticals

This clinical study is designed to evaluate the dopamine receptor occupancy of LB-102 in healthy subjects using positron emission tomography (PET).

Key Points: 
  • This clinical study is designed to evaluate the dopamine receptor occupancy of LB-102 in healthy subjects using positron emission tomography (PET).
  • Amisulpride, which is not available in the US, is used for the treatment of schizophrenia and is widely prescribed in over 50 countries, including the EU.
  • The goal of this Phase 1b study is both to confirm dopamine target engagement and assist in dose selection for our upcoming Phase 2 study in acute schizophrenia patients.
  • A first-in-human, double-blind placebo-controlled Phase 1 study designed to test the safety and pharmacokinetics of LB-102 was completed over the summer of 2020.

DGAP-News: PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.

Retrieved on: 
Tuesday, October 6, 2020
Psychoactive drugs, Drugs, Chemical compounds, Pyrrolidines, Antidepressants, Atypical antipsychotics, Anesthesia, RTT, Amisulpride, Postoperative nausea and vomiting, Remimazolam, Vomiting, remimazolam, PAION

PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.

Key Points: 
  • PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.
  • Scheduling by DEA represents the final requirement for BYFAVO(TM) to be marketed in the U.S., with launch expected by the end of 2020.
  • Our first product, BARHEMSYS(R) (amisulpride injection) for postoperative nausea & vomiting, was launched in August and we are already registering product sales.
  • The topline data of a Phase III trial in general anesthesia are expected in the second half of 2020.

LB Pharmaceuticals Inc Secures $10.0 Million in Additional Financing

Retrieved on: 
Friday, September 25, 2020
Biotechnology, Technology, Health, General Health, Pharmaceutical, Mental health, Other Science, Other Technology, Research, Science, Clinical trials, Psychoactive drugs, Chemical compounds, Atypical antipsychotics, Drugs, Pyrrolidines, Amisulpride, Antidepressants, Antiemetics, Corporate finance, Convertible bond, Convertible security, Sulpiride, LB-102, LB Pharmaceuticals

LB Pharmaceuticals Inc, a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, today announced the closing of a $10.0 million convertible note offering through a private placement to existing and new investors.

Key Points: 
  • LB Pharmaceuticals Inc, a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, today announced the closing of a $10.0 million convertible note offering through a private placement to existing and new investors.
  • The notes are structured to convert into equity as part of the Companys Series B financing.
  • Proceeds from this convertible note financing will support continued clinical development of the Companys lead asset, LB-102.
  • LB-102 has the potential to offer schizophrenia patients the benefits of amisulpride at a lower dose than amisulpride.