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Psych Drugs

Otsuka And Proteus® Announce The First U.S. FDA Approval of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor)

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ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. The ABILIFY MYCITE System includes: ABILIFY MYCITE, the MYCITE® Patch (wearable sensor); the MYCITE APP (a smartphone application); and web-based portals for healthcare providers and caregivers1 The system records medication […]

Alkermes Initiates Rolling Submission of ALKS 5461 New Drug Application for Major Depressive Disorder

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Company Expects to Complete Submission for Fast Track Designated Medicine by Year-End 2017 DUBLIN–(BUSINESS WIRE)–Aug. 21, 2017– Alkermes plc (NASDAQ:ALKS) today announced the initiation of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a […]

Alkermes Announces Positive Preliminary Topline Results From Phase 3 Antipsychotic Efficacy Study of ALKS 3831 for Treatment of Schizophrenia

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Once-Daily, Oral Product Candidate Demonstrated Antipsychotic Efficacy Statistically Superior to Placebo and Similar to Olanzapine in ENLIGHTEN-1 Study Management to Hold Conference Call Today at 4:30 p.m. ET DUBLIN–(BUSINESS WIRE)–Jun. 29, 2017– Alkermes plc (NASDAQ: ALKS) today announced positive preliminary topline results from ENLIGHTEN-1, the first of two key phase 3 studies in the ENLIGHTEN […]

Alkermes Announces Initiation of Study 217 for ALKS 5461 for Treatment of Major Depressive Disorder

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Phase 3b Study Designed to Further Evaluate ALKS 5461’s Potential Benefits on Mood Domains Regulated by Endogenous Opioid Modulation Company Reiterates Plans to Submit New Drug Application to FDA by Year-End 2017 DUBLIN–(BUSINESS WIRE)–Jun. 12, 2017– Alkermes plc (NASDAQ: ALKS) today announced the initiation of study 217, a phase 3b trial of ALKS 5461, a […]

Alkermes Announces Initiation of Phase 3 Study of ALKS 3831 in Young Adult Patients

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Designed to Assess Weight Gain Profile of Olanzapine Compared to ALKS 3831 in Patients Diagnosed With Schizophrenia, Schizophreniform or Bipolar I Disorder Who Are Early in Their Illness Supportive Study in the ENLIGHTEN Clinical Development Program for ALKS 3831, an Investigational, Novel, Once-Daily, Oral Atypical Antipsychotic for the Treatment of Schizophrenia DUBLIN–(BUSINESS WIRE)–Jun. 8, 2017– […]

FDA Approves Two-Month ARISTADA® for Treatment of Schizophrenia

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First and Only Long-Acting Atypical Antipsychotic With Two-Month Dosing Option Approval Expands ARISTADA’s Product Offerings to Include Once-Monthly, Once-Every-Six-Weeks and Once-Every-Two-Months Dosing Durations DUBLIN–(BUSINESS WIRE)–Jun. 6, 2017– Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved two-month ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. […]

New Antidepressant “Fetzima” is Now in Pharmacies

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Forest Laboratories has just released their latest FDA-approved medication to treat adults with Major Depressive Disorder called “Fetzima” with the generic name of “Levomilnacipran ER”. It is available in 20mg, 40mg, 80mg and 120mg tablets. It works on Serotonin and Norepinephrine receptors, which means that it is a cousin of antidepressants such as Cymbalta, Effexor, and […]

Introducing the New Kid on the Block to Treat Depression: “Brintellix”

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Introducing the New Kid on the Block to Treat Depression: “Brintellix”. October 1, 2013-Takeda Pharmaceuticals has just released their latest FDA-approved medication to treat adults with Major Depressive Disorder called “Brintellix” with the generic name of “Vorioxetine”. It is available in 5mg, 10mg, and 20mg tablets. It works on Serotonin receptors, which means that it […]

Why Take a Pill Every Day? One Shot per Month

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Highlight: Abilify Maintena Have I taken my meds today? I think so. This morning, right? No, that was yesterday… The lastest breakthrough in new psychiatry meds is Abilify Maintena. Currently, it is only FDA-approved for the treatment of Schizophrenia. But remember all those TV ads about Abilify being used to make your antidepressant work better? […]

New Sleeping Pill Is Coming Soon

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The FDA recently called for a decrease in the recommended dosage of Ambien, a medication used to treat people who have trouble going to sleep. This was in part due to many reports of people having a sleep-walking type of event in which the person feels wide awake at the time, but has no memory […]

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