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PAXIL

Phase 1

Anxiety Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Jan 20, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED

Total Trials1

Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

PAXIL · 2 trials · 2 indications

Phase 1 2

Indication

NCT04311463Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican ParticipantsAnxiety Disorders

COMPLETED38 Analytics

NCT00749359PAXIL CR Bioequivalence StudyDepressive Disorder

COMPLETED166 Analytics

PHASE1COMPLETED

Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants

Anxiety Disorders

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PHASE1COMPLETED

PAXIL CR Bioequivalence Study

Depressive Disorder

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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of Paroxetine

Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose

Blood samples were collected at indicated time points for the analysis of Cmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis.

Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUC[0-t]) of Paroxetine

Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose

Blood samples were collected at indicated time points for the analysis of AUC(0-t) of Paroxetine. PK parameters were analyzed using non-compartmental analysis.

Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Paroxetine

Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose

Blood samples were collected at indicated time points for the analysis of AUC(0-inf) of Paroxetine. PK parameters were analyzed using non-compartmental analysis.

Percentage of AUC (0 to Infinity) Obtained by Extrapolation (%AUCex) of Paroxetine

Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose

Blood samples were collected at indicated time points for the analysis of %AUCex of Paroxetine. PK parameters were analyzed using non-compartmental analysis.

Time of the Maximum Measured Plasma Concentration (Tmax) of Paroxetine

Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose

Blood samples were collected at indicated time points for the analysis of Tmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis.

Elimination Half-life (t1/2) of Paroxetine

Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose

Blood samples were collected at indicated time points for the analysis of t1/2 of Paroxetine. PK parameters were analyzed using non-compartmental analysis.

Terminal Elimination Rate Constant (Kel) of Paroxetine

Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose

Blood samples were collected at indicated time points for the analysis of Kel of Paroxetine. PK parameters were analyzed using non-compartmental analysis.

Paroxetine blood levels

measured up to 168 hours after a single dose.

Secondary Endpoints

Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)

Up to 25 days

Number of Participants With Abnormal Vital Signs

Up to 25 days

Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs

measured up to 168 hours after a single dose and throughout study

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelCROSSOVER

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Paroxetine hydrochloride followed by PAXIL	EXPERIMENTAL	-
PAXIL followed by paroxetine hydrochloride	EXPERIMENTAL	-
open label treatment	EXPERIMENTAL	On each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1.

Interventions

Name	Type	Description
Paroxetine hydrochloride	DRUG	Paroxetine hydrochloride will be administered.
PAXIL (Paroxetine hydrochloride )	DRUG	PAXIL will be administered.
Paxil CR	DRUG	Paxil CR 37mg tablet manufactures at two different sites

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Eligibility Criteria

Age Range18 Years to 55 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Healthy adult male and female participants aged between 18 and 55 years. * Participant is a light smoker (someone who smokes 9 or less cigarettes per day) or non- or an ex-smoker (someone who completely stopped smoking for at least 6 months before day 1 of this study). * With ...

Countries:MexicoUnited States

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Competitive Landscape -Anxiety Disorders 30 trials

Company	Ticker	Trials	Lead Phase	Drugs
Definium Therapeutics, Inc.	DFTX	2	PHASE3	DT120
Vistagen Therapeutics, Inc.	VTGN	3	PHASE3	Fasedienol
Vanda Pharmaceuticals Inc.	VNDA	1	PHASE3	VQW-765
AbbVie, Inc.	ABBV	1	PHASE2	ABBV-932, Antidepressant Therapy
Masimo Corporation	MASI	1	PHASE1	Diprivan, Astra-Zeneca
Psyence Biomedical Ltd.	PBM	1	PHASE2	Psilocybin therapy
Neuronetics, Inc.	STIM	2	-	Undisclosed
Aura Biosciences Inc	AURA	1	-	Undisclosed
Cooper Companies, Inc.	COO	1	N/A	Undisclosed
Vera Therapeutics, Inc. Class A	VERA	1	N/A	Undisclosed
Design Therapeutics, Inc.	DSGN	1	N/A	Undisclosed

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Frequently asked questions about PAXIL

What is PAXIL used for?

PAXIL is used for anxiety disorders and depressive disorder. It is a small molecule developed by GSK plc (ticker: GSK) in the psychiatry therapeutic area. PAXIL is an investigational drug that has completed Phase 1 clinical trials.

Who makes PAXIL?

PAXIL is developed by GSK plc, which trades under the ticker GSK. The drug is a small molecule being studied for anxiety disorders and depressive disorder. It has completed Phase 1 clinical trials.

What phase is PAXIL in?

PAXIL is in Phase 1 clinical development. It has completed one Phase 1 trial with 166 participants and another with 38 participants. PAXIL is investigational and not yet approved by regulatory authorities.

What clinical trials is PAXIL in?

PAXIL has been studied in two completed Phase 1 trials. NCT00749359 was a bioequivalence study in depressive disorder with 166 participants in the United States. NCT04311463 was a bioequivalence study in anxiety disorders with 38 participants in Mexico.

Is PAXIL the same as paroxetine?

PAXIL is a brand name for the drug paroxetine. Clinical trials have studied bioequivalence of paroxetine and PAXIL, indicating they are intended to be the same medication. PAXIL is developed by GSK plc.