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ADASUVE

Phase 1

BiPolar | Small molecule | Psychiatry |Teva Pharmaceutical Industries Limited|Trials Updated: Nov 12, 2021

ADASUVE development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2014

ADASUVE target and mechanism

ModalitySmall molecule

Also known as STACCATO® Loxapine for Inhalation

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

ADASUVE clinical trials

ADASUVE · 1 trial · 1 indication

Phase 1 1
NCT02184767Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic MedicationBiPolar
COMPLETED30 Analytics
PHASE1COMPLETED
Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication
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Study Endpoints

Primary Endpoints

area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t)
48 hours

Secondary Endpoints

area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
48 hours
ratio of AUC0-t to AUC0-inf (AUC0-t/AUC0-inf)
48 hours
maximum observed plasma drug concentration (Cmax)
48 hours
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
ADASUVE®EXPERIMENTALoral inhalation using a single-use, hand-held, inhaler; dosage determined by the investigator according the participants weight

Interventions

NameTypeDescription
ADASUVE®DRUGADASUVE® 2.5, 5, or 10 mg
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Eligibility Criteria

Age Range10 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion 1. Written informed consent is obtained from each patient's parent or legal guardian and written assent is obtained from each patient. 2. The patient is a boy or girl 10 through 17 years of age. 3. The patient is within the 2.5 to 97.5 percentile for body mass index (BMI) on the basis of ...

Countries:United States
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Frequently asked questions about ADASUVE

What is ADASUVE used for?

ADASUVE is being studied in bipolar disorder, specifically in children and adolescents 10 through 17 years of age with any condition warranting chronic use of an antipsychotic medication. It is a small molecule in the psychiatry therapeutic area. The clinical program has focused on safety and pharmacokinetics in this pediatric population.

Who makes ADASUVE?

ADASUVE is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical trial evaluating the drug in pediatric patients with bipolar disorder and other conditions requiring chronic antipsychotic treatment.

What phase is ADASUVE in?

ADASUVE is in Phase 1 development. The single listed trial, NCT02184767, is a Phase 1 study that has been completed. The program has one total trial, with no active trials currently listed, and enrolled 30 participants.

What clinical trials is ADASUVE in?

ADASUVE has been evaluated in one completed clinical trial, NCT02184767, titled a study to assess the safety and pharmacokinetics of ADASUVE at doses of 2.5, 5, or 10 mg in children and adolescents 10 through 17 years of age with any condition warranting chronic use of an antipsychotic medication. It was conducted in the United States.

Is ADASUVE the same as ADASUVE®?

Yes, ADASUVE and ADASUVE® refer to the same drug. The registered trademark symbol is simply a notation of the brand name, and both forms appear in reference to the same product developed by Teva Pharmaceutical Industries Limited for bipolar disorder and related conditions requiring chronic antipsychotic treatment.

How was the ADASUVE pediatric trial designed?

The ADASUVE trial NCT02184767 was an uncontrolled Phase 1 study, not randomized and not double blind. It enrolled 30 participants aged 10 through 17 years, included both sexes, did not use healthy volunteers, and assessed safety and pharmacokinetics at doses of 2.5, 5, or 10 mg.