SUNOVION

Otsuka and Sunovion Initiate Clinical Development of Ulotaront for the Adjunctive Treatment of Major Depressive Disorder

Retrieved on: 
Thursday, December 1, 2022

Ulotaront, which is also being evaluated in Phase 3 clinical development for the treatment of schizophrenia, is the first TAAR1 agonist to be studied as an adjunctive therapy in the treatment of MDD.

Key Points: 
  • Ulotaront, which is also being evaluated in Phase 3 clinical development for the treatment of schizophrenia, is the first TAAR1 agonist to be studied as an adjunctive therapy in the treatment of MDD.
  • Ulotaront was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in 2019.
  • Its also the first TAAR1 agonist to enter into a Phase 2/3 clinical study as an adjunctive therapy for MDD.
  • Major depressive disorder is a chronic debilitating disease characterized by symptoms that last at least two weeks causing significant functional impairment.

Sunovion and Otsuka Initiate Phase 3 Clinical Development of Non-Racemic Amisulpride for the Treatment of People with Bipolar Depression

Retrieved on: 
Wednesday, February 9, 2022

Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride (SEP-4199) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression).

Key Points: 
  • Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride (SEP-4199) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression).
  • We are encouraged by our Phase 2 clinical results and look forward to enhancing our understanding of non-racemic amisulpride and its potential to help address unmet needs in the treatment of bipolar depression.
  • Through our collaboration with Sunovion, we hope to advance SEP-4199, which we believe shows promise for the treatment of people with bipolar depression.
  • Non-racemic amisulpride (85:15 ratio of aramisulpride to esamisulpride; SEP-4199) is in Phase 3 clinical development for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression).

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

Retrieved on: 
Thursday, September 30, 2021

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.

Sunovion and BIAL Enter European Licensing Agreement for Apomorphine Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes

Retrieved on: 
Thursday, September 2, 2021

If you take nitroglycerin under your tongue (sublingual) while using KYNMOBI, your blood pressure may decrease and cause dizziness.

Key Points: 
  • If you take nitroglycerin under your tongue (sublingual) while using KYNMOBI, your blood pressure may decrease and cause dizziness.
  • Your healthcare provider may prescribe a medicine called an antiemetic, such as trimethobenzamide to help prevent nausea and vomiting.
  • Dizziness can happen when KYNMOBI treatment is started or when the KYNMOBI dose is increased.
  • For a copy of this release, visit Sunovions website at www.sunovion.com
    1 Parkinsons Disease Foundation Website: https://www.parkinson.org/about-us/Press-Room/Press-Releases/New-Study-S... .