Nei prossimi anni si potranno avere molti nuovi farmaci per la cura delle malattie mentali, posto che i trial clinici in corso, relativi alle nuove, cure diano esito positivo.

Le persone affette da disturbi mentali sperimentano tassi di disabilità e di mortalità molto più elevati rispetto alla media. Persone affette da depressione maggiore e schizofrenia hanno una possibilità del 40-60% maggiore rispetto al resto della popolazione di morire prematuramente per problemi di salute fisica, che spesso non vengono affrontati (come cancro, malattie cardiovascolari, diabete o infezione da HIV), e di suicidio (che è la seconda causa di mortalità nella popolazione giovane).

Molti disturbi necessitano di cure innovative dato che quelle attualmente disponibili non sempre permettono un controllo adeguato dei sintomi: la depressione, i disturbi affettivi bipolari, la schizofrenia, i disturbi d’ansia, la demenza, i disturbi correlati all’uso di sostanze psicoattive, i deficit intellettivi e i disturbi dello sviluppo e del comportamento, che di solito si manifestano durante l’infanzia e l’adolescenza, incluso l’autismo.

Le compagnie Biofarmaceutiche stanno attualmente sviluppando più di 110 nuove sostanze rivolte al trattamento delle Malattie Mentali (36 solo per la terapia della Schizofrenia) secondo i dati emessi da Pharmaceutical Research and Manufacturers of America (PhRMA). Non tutte le sostanze in sviluppo si affidano al vecchio paradigma di blocco dei neurorecettori: sono diversi i farmaci che avranno target neuroendocrini. Eccovi il grafico riassuntivo dei farmaci in fase di sviluppo aggiornato al 2015:

 

nuovi-psicofarmaci-grafico

Alcuni dei farmaci inseriti nei trials clinici sono semplici riformulazioni od associazioni di farmaci già esistenti, ed altri hanno già fallito le fasi più avanzate di sperimentazione (ad esempio il Bitopertin). Alcuni farmaci sono stati inseriti in commercio già nel 2016, come ad esempio la Vortioxetina, o l’Abilify Maintena. In ogni caso il messaggio che viene trasmesso a medici ed a pazienti è che molte nuove possibilità di cura sono in fase di concreto sviluppo. La lista di tutti i farmaci include, oltre ai già citati farmaci per la schizofrenia che rappresentano il gruppo più consistente, 29 sostanze per la depressione, 20 per la dipendenza/abuso di sostanze, 15 per l’ADHD e 15 per i Disturbi d’Ansia. Di seguito ritrovate un riassunto di tutte le sostanze:

 

DISTURBI D’ANSIA

aloradine
(sensory receptor cell modulator)

Pherin Pharmaceuticals

Los Altos, CA

social anxiety disorder (social phobia)

Phase II completed www.pherin.com

alprazolam patch

Nuvo Research

Mississauga, Canada

panic disorder

Phase I www.nuvoresearch.com

AVN-101
(5-HT6 receptor antagonist)

AllaChem

Hallandale Beach, FL

Avineuro

San Diego, CA

anxiety

Phase II www.allachem.com www.avineuro.com

AVP-923 (dextromethorphan/quinidine xed-dose combination)

Avanir

Aliso Viejo, CA

aggitation in Alzheimer’s disease

Phase II www.avanir.com

bitopertin (GlyT1 inhibitor)

Roche

Nutley, NJ

obsessive-compulsive disorder (see also schizophrenia)

Phase II www.roche.com

brexpiprazole
(dopamine partial agonist)

Lundbeck

Deer eld, IL

Otsuka Pharmaceutical

Rockville, MD

agitation associated with
Alzheimer’s disease
(see also ADHD, depression, schizophrenia) —————————————– post-traumatic stress disorder

(PTSD)

Phase III www.lundbeck.com www.otsuka.com

—————————————– Phase III
www.lundbeck.com www.otsuka.com

Brintellix® vortioxetine

Lundbeck

Deer eld, IL

Takeda Pharmaceuticals

Deer eld, IL

generalized anxiety disorder (see also depression)

—————————————– anxiety disorders
(children and adolescents)

Phase III
www.lundbeck.com www.takeda.com —————————————– Phase II
www.lundbeck.com www.takeda.com

ELND005

Transition Therapeutics

Toronto, Canada

agitation and aggression associated with Alzheimer’s disease
(Fast Track)

Phase II www.transitiontherapeutics.com

ganaxolone

Marinus Pharmaceuticals

New Haven, CT

PTSD

Phase II www.marinuspharma.com

guanfacine extended release (SPD503)

Shire

Wayne, PA

generalized anxiety disorder separation anxiety disorder, social phobia

Phase II completed www.shire.com

IW-2143

Bionomics

Thebarton, Australia

Ironwood Pharmaceuticals

Cambridge, MA

anxiety

Phase I www.bionomics.com.au www.ironwoodpharma.com

JNJ-42165279

Janssen Research & Development

Raritan, NJ

anxiety disorders

Phase I www.janssenrnd.com

nepicastat (SYN117)

Biotie Therapies

Turku, Finland

U.S. Department of Defense

Washington, DC

PTSD
(see also substance use)

Phase II www.biotie.com

SRX246
(vasopressin 1a receptor antagonist)

Azevan Pharmaceuticals

Bethlehem, PA

stress-related a ective disorders

Phase I www.azevan.com

Viibryd® vilazodone

Forest Laboratories

New York, NY

generalized anxiety disorder (see also depression)

Phase III www.frx.com

ADHD

ADHD therapeutic

Neos Therapeutics

Grand Prairie, TX

ADHD

in clinical trials www.neostx.com

AR08
(adrenergic receptor agonist)

Arbor Pharmaceuticals

Atlanta, GA

ADHD

Phase II www.arborpharma.com

ATS
(dexamfetamine transdermal)

Noven Pharmaceuticals

Miami, FL

ADHD

Phase II www.noven.com

brexpiprazole
(dopamine partial agonist)

Lundbeck

Deer eld, IL

Otsuka Pharmaceutical

Rockville, MD

ADHD (adults)
(see also anxiety, depression, schizophrenia)

Phase II www.lundbeck.com www.otsuka.com

EB-1020
(triple reuptake inhibitor)

Euthymics Biosciences

Cambridge, MA

ADHD (adults)

Phase II www.euthymics.com

edivoxetine

Eli Lilly

Indianapolis, IN

ADHD

Phase II/III www.lilly.com

eltoprazine

Amarantus Bioscience

San Francisco, CA

ADHD (adults)

Phase II www.amarantus.com

HLD200
(methylphenidate modi ed release)

Highland Therapeutics

Toronto, Canada

Ironshore Pharmaceuticals and Development
Toronto, Canada

ADHD (pediatric)

Phase III www.highlandtherapeutics.com

metadoxine extended release

Alcobra

Tel-Aviv, Israel

ADHD (adults)

Phase II/III www.alcobra-pharma.com

NT0102

Neos Therapeutics

Grand Prairie, TX

ADHD (pediatric)

Phase III www.neostx.com

NT0202
(amphetamine polistirex disintegrating tablet, extended release)

Neos Therapeutics

Grand Prairie, TX

ADHD

application submitted www.neostx.com

ORADUR®-ADHD methylphenidate sustained release

DURECT

Cupertino, CA

ADHD

Phase I www.durect.com

SEP-225289
(triple reuptake inhibitor)

Sunovion

Marlborough, MA

ADHD

Phase II www.sunovion.com

SPN-810 (molindone)

Supernus Pharmaceuticals

Rockville, MD

impulsive aggression in ADHD

Phase II completed www.supernus.com

SPN-812
(adrenergic uptake inhibitor)

Supernus Pharmaceuticals

Rockville, MD

ADHD (adults)

Phase II completed www.supernus.com

DISTURBI DELLO SPETTRO AUTISTICO

AT001
(uoxetine rapid dissolve) ORPHAN DRUG

Autism Therapeutics

New York, NY

autism
(repetitive behaviors) (Fast Track)

Phase III www.autismtherapeutics.com

CM-AT

Curemark

Rye, NY

autism (Fast Track)

application submitted www.curemark.com

CNDO-201 (Trichuris suis ova)

Coronado Biosciences

Burlington, MA

autism

Phase II www.coronadobiosciences.com

memantine

Forest Laboratories

New York, NY

pervasive developmental disorder not otherwise speci ed, Asperger’s syndrome, autism
(pediatric)

Phase II completed www.frx.com

RG7314
(vasopressin-1 receptor antagonist)

Roche

Nutley, NJ

autism

Phase II www.roche.com

syntocinon nasal spray

Retrophin

New York, NY

autism
(see also schizophrenia)

Phase II www.retrophin.com

DISTURBO BIPOLARE

Abilify® Maintena® aripiprazole for extended release injectable suspension
(depot injection)

Otsuka Pharmaceutical

Rockville, MD

bipolar disorder

Phase III www.otsuka.com

cariprazine

Forest Laboratories

New York, NY

manic or mixed episodes associated with bipolar I disorder
(see also depression, schizophrenia)

application submitted www.frx.com

Latuda® lurasidone

Sunovion

Marlborough, MA

bipolar maintenance (see also depression)

Phase III www.sunovion.com

Rozerem®
ramelteon
(sublingual formulation)

Takeda Pharmaceutical

Deer eld, IL

bipolar 1 disorder

Phase III www.takeda.com

Saphris® asenapine

Forest Laboratories

New York, NY

Merck

Whitehouse Station, NJ

bipolar disorder
(children and adolescents)

Phase III www.frx.com www.merck.com

DEPRESSIONE MAGGIORE

ademetionine (MSI-195)

MSI Methylation Sciences

Burnaby, Canada

major depressive disorder

Phase II www.methylationsciences.com

ALKS 5461 (buprenorphine/samidorphan)

Alkermes

Waltham, MA

major depressive disorder (Fast Track)

Phase III www.alkermes.com

amitifadine
(triple reuptake inhibitor)

Euthymics Bioscience

Cambridge, MA

major depressive disorder

Phase II/III www.euthymics.com

armoda nil

Teva Pharmaceutical

North Wales, PA

major depressive disorder associated with bipolar 1 disorder
(see also eating disorders)

Phase III completed www.tevapharm.com

AVP-786
(deuterium modi ed dextromethorphan and ultra-low dose quinidine)

Avanir Pharmaceuticals

Aliso Viejo, CA

Concert Pharmaceuticals

Lexington, MA

treatment-resistant depression

Phase I completed www.avanir.com www.concertpharma.com

AZD6423
(NMDA modulator)

AstraZeneca

Wilmington, DE

suicidal ideation

Phase I www.astrazeneca.com

Botox® onabotulinumtoxinA

Allergan

Irvine, CA

major depressive disorder

Phase II www.allergan.com

brexpiprazole
(dopamine partial agonist)

Lundbeck

Deer eld, IL

Otsuka Pharmaceutical

Rockville, MD

major depressive disorder (adjunctive treatment) (see also ADHD, anxiety, schizophrenia)

Phase III www.lundbeck.com www.otsuka.com

Brintellix® vortioxetine

Lundbeck

Deer eld, IL

Takeda Pharmaceutical

Deer eld, IL

depressive disorders (children and adolescents) (see also anxiety)

Phase II www.lundbeck.com www.takeda.com

cariprazine

Forest Laboratories

New York, NY

bipolar depression, major depressive disorder (adjunctive treatment)
(see also bipolar, schizophrenia)

Phase II www.frx.com

CERC-301
(NR2B antagonist)

Cerecor

Baltimore, MD

major depressive disorder
(Fast Track) —————————————– active suicidal ideation

Phase II
www.cerecor.com —————————————– Phase II
www.cerecor.com

DSP-1053
(serotonin uptake inhibitor)

Sunovion

Marlborough, MA

major depressive disorder

Phase I www.sunovion.com

esketamine (intranasal)

Janssen Research & Development

Raritan, NJ

treatment-resistant major depressive disorder
(Fast Track)

Phase II www.janssenrnd.com

GLYX-13

Naurex

Evanston, IL

major depressive disorder (Fast Track)

Phase II www.naurex.com

HT-2157
(GALR3 antagonist)

Dart NeuroScience

San Diego, CA

major depressive disorder

Phase II www.dartneuroscience.com

JNJ-42847922

Janssen Research & Development

Raritan, NJ

major depressive disorder

Phase I www.janssenrnd.com

Latuda® lurasidone

Sunovion

Marlborough, MA

major depressive disorder with mixed features
(see also bipolar)

Phase III www.sunovion.com

LY03005

Luye America Pharmaceuticals

Princeton, NJ

major depressive disorder

Phase I www.luye.cn

LY2940094
(NOC-1 antagonist)

Eli Lilly

Indianapolis, IN

major depressive disorder (see also substance use)

Phase II www.lilly.com

mifepristone

Corcept Therapeutics

Menlo Park, CA

major depression disorder with psychotic features

Phase III www.corcept.com

MIN-117 (5-HT1A/5-HTT receptor antagonist)

Minerva Neurosciences

Cambridge, MA

major depressive disorder

Phase II www.minervaneurosciences.com

NRX-1074
(NMDA receptor agonist)

Naurex

Evanston, IL

major depressive disorder

Phase I www.naurex.com

NSI-189
(stimulating neurogenesis)

Neuralstem

Germantown, MD

major depressive disorder

Phase I www.neuralstem.com

Pristiq® desvenlafaxine

P zer

New York, NY

major depressive disorder (children and adolescents)

Phase III www.pfizer.com

RG1578 (mGluR2)

Roche

Nutley, NJ

major depressive disorder

Phase II www.roche.com

RG7090
(mGluR5 antagonist)

Roche

Nutley, NJ

treatment-resistant depression

Phase II www.roche.com

RO4995819

Roche

Nutley, NJ

major depressive disorder

Phase II www.roche.com

tedatioxetine

Lundbeck

Deer eld, IL

Takeda Pharmaceutical

Deer eld, IL

major depressive disorder

Phase II www.lundbeck.com www.takeda.com

Viibryd® vilazodone

Forest Laboratories

New York, NY

major depressive disorder (adolescents)
(see also anxiety)

Phase III www.frx.com

DISTURBI DEL COMPORTAMENTO ALIMENTARE

armoda nil

Teva Pharmaceutical

North Wales, PA

Lindner Center of HOPE

Cincinnati, OH

binge-eating disorder (see also depression)

Phase III www.tevapharm.com

LDX (lisdexamfetamine)

Shire

Wayne, PA

binge-eating disorder (adults)

Phase III www.shire.com

SCHIZOFRENIA

ABT-126
(alpha7 NNR antagonist)

AbbVie

North Chicago, IL

cognition impairment associated with schizophrenia (CIAS)

Phase II www.abbvie.com

ADX71149/JNJ-40411813 (mGlu2 PAM modulator)

Addex Therapeutics

Geneva, Switzerland

Janssen Research & Development

Raritan, NJ

schizophrenia

Phase II www.addextherapeutics.com www.janssenrnd.com

ALKS 3831 (olanzapine/samidorphan xed-dose combination)

Alkermes

Waltham, MA

schizophrenia

Phase II www.alkermes.com

AMG 581

Amgen

Thousand Oaks, CA

schizophrenia

Phase I www.amgen.com

AQW051
(alpha7 nicotinic acetylcholine receptor agonist)

Novartis Pharmaceuticals

East Hanover, NJ

CIAS

Phase II completed www.novartis.com

aripiprazole lauroxil (ALKS 9072)

Alkermes

Waltham, MA

schizophrenia

Phase III www.alkermes.com

AVL-3288
(alpha7 nicotinic acetylcholine receptor modulator)

Anvyl Pharmaceuticals

Irvine, CA

CIAS

Phase I www.anvylllc.com

AVN-211
(5-HT6 receptor antagonist)

AllaChem

Hallandale Beach, FL

Avineuro Pharmaceuticals

San Diego, CA

schizophrenia

Phase II www.allachem.com www.avineuro.com

BI-409306

Boehringer Ingelheim Pharmaceuticals

Ridge eld, CT

schizophrenia

Phase I completed www.boehringer-ingelheim.com

bitopertin (GlyT1 inhibitor)

Roche

Nutley, NJ

schizophrenia-suboptimally controlled symptoms
(see also anxiety)

Phase III www.roche.com

brexpiprazole
(dopamine partial agonist)

Lundbeck

Deer eld, IL

Otsuka Pharmaceutical

Rockville, MD

schizophrenia
(see also ADHD, anxiety, depression)

Phase III www.lundbeck.com www.otsuka.com

cariprazine

Forest Laboratories

New York, NY

schizophrenia
(see also bipolar, depression)

application submitted www.frx.com

CEP-26401 (irdabisant)

Teva Pharmaceutical

North Wales, PA

CIAS

Phase I completed www.tevapharm.com

encenicline (alpha-7 agonist)

Forum Pharmaceuticals

Watertown, MA

CIAS

Phase III www.forumpharma.com

FRM-6308 (PDE10 inhibitor)

Forum Pharmaceuticals

Watertown, MA

schizophrenia

Phase I www.forumpharma.vom

Invega® Sustenna® paliperidone palmitate

Alkermes

Waltham, MA

Janssen Research & Development

Raritan, NJ

schizoa ective disorder

—————————————– schizophrenia (3 month injectable)

Phase III
www.alkermes.com www.janssenrnd.com —————————————– Phase III
www.alkermes.com www.janssenrnd.com

ITI-007
(5-HT2A serotonin receptor antagonist)

Intra-Cellular Therapies

New York, NY

schizophrenia

Phase II www.intracellulartherapies.com

ITI-214
(PDE1 inhibitor)

Intra-Cellular Therapies

New York, NY

Takeda Pharmaceuticals

Deer eld, IL

CIAS

Phase I www.intracellulartherapies.com www.takeda.com

LY03004
(risperidone controlled release)

Luye America Pharmaceuticals

Princeton, NJ

schizophrenia, schizoa ective disorder

Phase I www.luye.cn

MIN-101 (5-HT2A/sigma-2 receptor antagonist)

Minerva Neurosciences

Cambridge, MA

schizophrenia

Phase II www.minervaneurosciences.com

NW-3509
(potent sodium channel blocker)

Newron Pharmaceuticals

Bresso, Italy

schizophrenia

Phase I www.newron.com

OMS824
(PDE10 inhibitor)

Omeros

Seattle, WA

schizophrenia

Phase II www.omeros.com

PF-02545920 (PDE10 inhibitor)

P zer

New York, NY

schizophrenia (adjunctive treatment)

Phase II www.pfizer.com

PF-04958242
(AMPA receptor modulator)

P zer

New York, NY

schizophrenia

Phase I www.pfizer.com

PF-06412562

P zer

New York, NY

CAIS

Phase I www.pfizer.com

pimavanserin

ACADIA Pharmaceuticals

San Diego, CA

Parkinson’s disease psychosis

—————————————– Alzheimer’s disease psychosis, schizophrenia

Phase III
www.acadia-pharm.com —————————————– Phase II
www.acadia-pharm.com

RBP-7000 (dopamine-D2/serotonin-2 antagonist)

Reckitt Benckiser Pharmaceutical

Richmond, VA

schizophrenia

Phase III www.rb.com

ReldayTM
risperidone controlled release

DURECT

Cupertino, CA

Zogenix

San Diego, CA

schizophrenia

Phase I www.durect.com www.zogenix.com

RG7203
(PDE10A inhibitor)

Roche

Nutley, NJ

schizophrenia

Phase I www.roche.com

RO5545965

Roche

Nutley, NJ

schizophrenia

Phase I www.roche.com

RP5063
(partial agonist of dopamine and serotonin)

Reviva Pharmaceuticals

San Jose, CA

schizophrenia, schizoa ective disorder

Phase II www.revivapharma.com

Saphris® asenapine

Forest Laboratories

New York, NY

Merck

Whitehouse Station, NJ

schizophrenia (adolescents) (see also bipolar)

Phase III completed www.frx.com www.merck.com

SEP-363856

Sunovion

Marlborough, MA

schizophrenia

Phase I www.sunovion.com

syntocinon nasal spray

Retrophin

New York, NY

schizophrenia (see also autism)

Phase II www.retrophin.com

TAK-063
(PDE10A inhibitor)

Takeda Pharmaceuticals

Deer eld, IL

schizophrenia

Phase I www.takeda.com

zicronapine

Lundbeck

Deer eld, IL

schizophrenia

Phase III www.lundbeck.com

DIPENDENZA/ABUSO DI SOSTANZE

bupropion/mecamylamine once-daily tablet (QuitPak®)

Cary Pharmaceuticals

Great Falls, VA

smoking withdrawal

Phase I completed www.carypharma.com

Ch-mAb7F9 (METH-mAb)

InterveXion Therapeutics

Little Rock, AR

methamphetamine use disorder

Phase I completed www.intervexion.com

EMB-001 (metyrapone/oxazepam)

Embera NeuroTherapeutics

Sudbury, MA

cocaine use disorder

Phase I completed www.emberaneuro.com

lofexidine

US WorldMeds

Louisville, KY

National Institute on Drug Abuse

Bethesda, MD

opioid use disorder

Phase III www.usworldmeds.com www.drugabuse.gov

LY2940094
(NOC-1 antagonist)

Eli Lilly

Indianapolis, IN

alcohol use disorder (see also depression)

Phase II www.lilly.com

MN-166 (ibudilast)

MediciNova

La Jolla, CA

National Institute on Drug Abuse

Bethesda, MD

methamphetamine use disorder (Fast Track)

Phase II www.medicinova.com www.drugabuse.gov

naloxone nasal spray

Lightlake Therapeutics

London, United Kingdom

National Institute on Drug Abuse

Bethesda, MD

opioid use disorder

Phase II www.lightlaketherapeutics.com www.drugabuse.gov

nepicastat (SYN117)

Biotie Therapies

Turku, Finland

National Institute on Drug Abuse

Bethesda, MD

cocaine use disorder (see also anxiety)

Phase II www.biotie.com www.drugabuse.gov

OMS405
(PPAR-gamma agonist)

Omeros

Seattle, WA

opioid use disorder, smoking withdrawal

Phase II www.omeros.com

PF-05402536
(smoking cessation vaccine)

P zer

New York, NY

smoking withdrawal

Phase I www.pfizer.com

Probuphine® buprenorphine implant

Braeburn Pharmaceuticals

Princeton, NJ

Titan Pharmaceuticals

South San Francisco, CA

opioid use disorder

application submitted www.braeburnpharmaceuticals.com www.titanpharm.com

RBP-6000 (buprenorphine depot)

Reckitt Benckiser Pharmaceutical

Richmond, VA

opioid use disorder

Phase II www.rb.com

RBP-8000 (cocaine esterase)

Reckitt Benckiser Pharmaceutical

Richmond, VA

cocaine use disorder

Phase II www.rb.com

SEL-068
(nicotine antibodies)

Selecta Biosciences

Watertown, MA

smoking withdrawal

Phase I www.selectabio.com

TA-CD
(cocaine abuse vaccine)

Baylor College of Medicine

Houston, Texas

Celtic Pharma Holdings

Hamilton, Bermuda

National Institute on Drug Abuse

Bethesda, MD

cocaine use disorder

Phase II www.drugabuse.gov

TV-1380
(form of human plasma butyrylcholinesterase)

Teva Pharmaceutical

North Wales, PA

cocaine use disorders

Phase II www.tevapharm.com

ALTRI DISTURBI

Abilify® aripiprazole (once-weekly tablet)

Otsuka Pharmaceutical

Rockville, MD

Tourette’s syndrome

Phase III www.otsuka.com

AZD5213 (histamine-3 receptor antagonist)

AstraZeneca

Wilmington, DE

Tourette’s syndrome

Phase II www.astrazeneca.com

ecopipam

Psyadon Pharmaceuticals

Germantown, MD

Tourette’s syndrome

Phase II www.psyadonrx.com

PH80-PMD

Pherin Pharmaceuticals

Los Altos, CA

premenstrual dysphoric disorder, premenstrual syndrome

Phase II completed www.pherin.com

RG1662
(GABA-A alpha5 receptor modulator)

Roche

Nutley, NJ

cognitive impairment associated with Downs syndrome

Phase I www.roche.com

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Mi chiamo Valerio Rosso e sono un medico, psichiatra e psicoterapeuta ad orientamento psicoanalitico. Alcune persone mi conoscono anche come blogger o come musicista (…cercatemi su iTunes). La mia vita ruota attorno a molte cose: le neuroscienze, la psicoanalisi, la pedagogia ed il tema della formazione dell’Uomo, ma anche la musica ed il motociclismo nel mio tempo libero.
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