Receptor antagonists

Prometheus Biosciences Announces Initiation of APOLLO-CD Phase 2a Clinical Trial of PRA023 in Moderate-to-Severe Crohn’s Disease

Retrieved on: 
Monday, August 2, 2021

SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) --  Prometheus Biosciences, Inc. (Nasdaq: RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the APOLLO-CD Phase 2a clinical trial evaluating PRA023 for moderate-to-severe Crohn’s disease (CD), with first patient enrollment.  

Key Points: 
  • We believe PRA023 has the potential to address the highest unmet need of fibrostenotic disease in this patient population.
  • The APOLLO-CD Phase 2a trial is an open-label study designed to evaluate the proof-of-concept efficacy and safety of PRA023 in moderate-to-severe Crohns disease with centrally read endoscopy as the primary endpoint.
  • Prometheus has recently completed the dosing phase of the Phase 1a clinical trial of PRA023, a single center, double-blind, placebo-controlled trial to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in normal healthy volunteers.
  • Safety and tolerability observed to date supports the initiation of this Phase 2a trial.

OWP Pharmaceuticals Announces Patent Issuance for the First-Ever Oral Liquid Suspension of Quetiapine for the Treatment of Schizophrenia and Bipolar Disorder

Retrieved on: 
Thursday, July 1, 2021

OWP announced today that the United States Patent and Trademark Office (USPTO) has issued a patent to OWP for the first-ever oral liquid suspension of quetiapine.

Key Points: 
  • OWP announced today that the United States Patent and Trademark Office (USPTO) has issued a patent to OWP for the first-ever oral liquid suspension of quetiapine.
  • Quetiapine is an atypical antipsychotic and the tablets, for oral use, were first approved in the U.S. in 1997.
  • In schizophrenia, quetiapine is indicated for treatment in adolescents aged 13 to 17 years and adults.
  • It is also indicated as monotherapy for the acute treatment of depressive episodes in adult patients with bipolar I and bipolar II disorder.

Starton Therapeutics Phase 2 TROPIC-I Clinical Study will be First to Use Total Control Primary Endpoint in Superiority Study

Retrieved on: 
Wednesday, June 16, 2021

Total Control is a measure of no nausea, no vomiting, and no rescue medications; existing antiemetics have been approved using a Complete Response (CR) endpoint which only measures vomiting and rescue medications.

Key Points: 
  • Total Control is a measure of no nausea, no vomiting, and no rescue medications; existing antiemetics have been approved using a Complete Response (CR) endpoint which only measures vomiting and rescue medications.
  • The largest and most comprehensive meta-analysis of the use of olanzapine in CINV was published a few months ago (Chow 2021).
  • The meeting provided guidance for the design of the planned Phase 2 clinical study and endpoint strategy, as well as planned work to support the validation of a nausea scale.
  • Neither the Company nor any other person assumes responsibility for the accuracy or completeness of these statements.

Apomorphine (CAS 58-00-4) Global Market Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Friday, June 4, 2021

The "Apomorphine (CAS 58-00-4) Global Market Research Report 2021" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Apomorphine (CAS 58-00-4) Global Market Research Report 2021" report has been added to ResearchAndMarkets.com's offering.
  • This global report is a result of industry experts' diligent work on researching the world market of apomorphine.
  • The fifth chapter deals with apomorphine market trends and forecast, distinguish apomorphine manufacturers and suppliers.
  • The apomorphine global market report key points:

Alkermes Announces FDA Approval of LYBALVI™ for the Treatment of Schizophrenia and Bipolar I Disorder

Retrieved on: 
Tuesday, June 1, 2021

"Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.

Key Points: 
  • "Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.
  • "LYBALVI represents an important new treatment option for adults with schizophrenia or bipolar I disorder, their clinicians and caregivers, and reflects Alkermes' commitment to developing new therapies that support patient-centered care," said Richard Pops, Chairman and Chief Executive Officer at Alkermes.
  • The most common adverse events (AEs) for both the LYBALVI and olanzapine treatment groups were weight gain, somnolence and dry mouth.
  • ENLIGHTEN-2 evaluated the weight gain profile of LYBALVI compared to olanzapine over six months in 561 patients with stable schizophrenia.

Alkermes Announces FDA Approval of LYBALVI™ for the Treatment of Schizophrenia and Bipolar I Disorder

Retrieved on: 
Tuesday, June 1, 2021

"Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.

Key Points: 
  • "Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.
  • "LYBALVI represents an important new treatment option for adults with schizophrenia or bipolar I disorder, their clinicians and caregivers, and reflects Alkermes' commitment to developing new therapies that support patient-centered care," said Richard Pops, Chairman and Chief Executive Officer at Alkermes.
  • The most common adverse events (AEs) for both the LYBALVI and olanzapine treatment groups were weight gain, somnolence and dry mouth.
  • ENLIGHTEN-2 evaluated the weight gain profile of LYBALVI compared to olanzapine over six months in 561 patients with stable schizophrenia.

BioXcel Therapeutics Announces FDA Acceptance for Filing of NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II

Retrieved on: 
Wednesday, May 19, 2021

The FDA has assigned a Prescription Drug User Fee Act (\xe2\x80\x9cPDUFA\xe2\x80\x9d) target action date of January 5, 2022.

Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (\xe2\x80\x9cPDUFA\xe2\x80\x9d) target action date of January 5, 2022.
  • On average, patients with these conditions experience more than a dozen episodes per year, the majority requiring pharmacologic treatment.
  • BXCL501 has been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders and dementia.
  • The Company recently received acceptance of its New Drug Application for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders.

BioXcel Therapeutics Announces Presentations at the ISBD 2021 Global Annual Conference

Retrieved on: 
Tuesday, May 11, 2021

BXCL501 has been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders and dementia.

Key Points: 
  • BXCL501 has been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders and dementia.
  • The Company recently submitted its New Drug Application to the FDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders.
  • The safety and efficacy of BXCL501 has not been established.\nBioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology.
  • BioXcel\xe2\x80\x99s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices.

AA Pharma Strengthens its Support of Canadian Clozapine Patients With Exclusive Rights to Blood Analyzer

Retrieved on: 
Tuesday, April 27, 2021

b'TORONTO, April 27, 2021 /CNW/ -AA Pharma, a Canadian company focused on legacy pharmaceutical products, has secured the exclusive Canadian rights for the use of a blood analyzer for patients prescribed Clozapine.

Key Points: 
  • b'TORONTO, April 27, 2021 /CNW/ -AA Pharma, a Canadian company focused on legacy pharmaceutical products, has secured the exclusive Canadian rights for the use of a blood analyzer for patients prescribed Clozapine.
  • "There is significant underutilization in this patient population because of barriers to treatment, including the requirement for regular blood monitoring," said Geoffrey Johnson, AA Pharma\'s Director, Sales & Marketing.
  • Results can also be securely shared with AA Pharma\'s patient registry, a Health Canada requirement, to ensure ongoing monitoring of patients\' health while taking clozapine.
  • The company is positioned to offer products from multiple strategic partners to provide creative and effective solutions.Learn more at http://www.inter-medico.com\n'

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

Retrieved on: 
Monday, April 26, 2021

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.