Tag Archives: Schizophrenia

November, 2018

29 November
Alkermes’ Investigational Schizophrenia Drug ALKS 3831 Meets Co-Primary Endpoints in Pivotal Phase 3 Study

DUBLIN, Nov. 29, 2018 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced positive topline results from ENLIGHTEN-2, a pivotal phase 3 study of ALKS 3831 (olanzapine/samidorphan), an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia. ENLIGHTEN-2 is the second of two key phase 3 studies in the ALKS 3831 …
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2 August
FDA Approves Indivior’s Perseris for Extended-Release Injectable Suspension for the Treatment of Schizophrenia

Slough, UK and Richmond, VA, 30 July 2018 – Indivior PLC (LON: INDV) today announces that on July 27, 2018 the U.S. Food and Drug Administration (FDA) approved PERSERISTM, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults. Clinically relevant levels were reached after the first injection of PERSERIS …
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18 December
Boehringer Ingelheim and Autifony Collaborate on a Novel Therapeutic Approach to a Range of CNS Disorders

Boehringer Ingelheim and Autifony Therapeutics Limited (“Autifony”) today announced that they have signed an agreement about certain aspects of Autifony’s voltage gated potassium channel modulator platform. Boehringer Ingelheim now has an exclusive option to purchase Autifony’s Kv3.1/3.2 positive modulator platform. Included in the agreement is the lead compound AUT00206, a …
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14 November
Allergan’s Vraylar Receives FDA Approval for Use in the Maintenance Treatment of Schizophrenia

DUBLIN, Nov. 13, 2017 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VRAYLAR™ (cariprazine) for the maintenance treatment of adults with schizophrenia. VRAYLAR is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment …
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14 November
FDA Approves Pill with Sensor that Digitally Tracks If Patients Have Ingested Their Medication

The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, …
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15 January
Boehringer Ingelheim Inks $262 Million CNS Deal with Arena Pharmaceuticals

INGELHEIM, Germany, and SAN DIEGO, Jan. 12, 2016 /PRNewswire/ — Boehringer Ingelheim and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that they have signed an exclusive agreement to conduct joint research to identify drug candidates targeting an undisclosed G protein-coupled receptor (GPCR), which belongs to the group of orphan CNS …
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6 October
FDA Approves Alkermes’ Schizophrenia Drug

DUBLIN–(BUSINESS WIRE)–Oct. 5, 2015– Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA™ (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body …
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