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Reboxetine

Phase 3

Fibromyalgia | Small molecule | Musculoskeletal |Pfizer, Inc.|Trials Updated: Jan 28, 2021

Reboxetine target and mechanism

Molecular targetSLC6A2
Target classInhibitor
ModalitySmall molecule

Also known as reboxetine monotherapy

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials5
Total Enrollment2,349

FDA Designations

No designations recorded

Reboxetine clinical trials

Reboxetine · 5 trials · 3 indications

Phase 3 1Phase 2 4
NCT00612170A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.Fibromyalgia
COMPLETED1,129 Analytics
PHASE3COMPLETED
A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.
FibromyalgiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in the endpoint mean pain score
14 weeks
Fibromyalgia Impact Questionnaire
14 weeks
Weekly Average Pain Score from the Daily Pain Diary.
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated
The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness.
visits 1-9
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 5 will be calculated.

Secondary Endpoints

Change from baseline in the endpoint mean sleep interference score
14 weeks
Patient Global Impression of Change
14 weeks
Multidimensional Assessment of Fatigue
14 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
3EXPERIMENTAL -
4SHAM_COMPARATOR -
1EXPERIMENTAL -
2EXPERIMENTAL -
Sertraline/[S,S]-Reboxetine-satellite150/4EXPERIMENTAL -
Sertraline/[S,S]-Reboxetine-satellite150/6EXPERIMENTAL -
sertraline-satelliteACTIVE_COMPARATOR -
sertraline-mainACTIVE_COMPARATOR -
Sertraline/[S,S]-Reboxetine-satellite150/2EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Sertraline/[S,S]-Reboxetine-mainEXPERIMENTAL -
[S,S]-reboxetine-mainACTIVE_COMPARATOR -

Interventions

NameTypeDescription
[S,S]-ReboxetineDRUG10 mg oral tablet once a day dosing
PlaceboDRUG0 mg oral tablet once a day dosing
sertraline/[S,S]-reboxetineDRUGTablets, 50mg sertraline/2mg \[S,S\]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg \[S,S\]-reboxetine for 5 and one half weeks.
sertralineDRUGTablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
[S,S]-reboxetine monotherapyDRUGTablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites145

Inclusion Criteria: * Male or female of any race, at least 18 years of age * Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) Exclusion Criteria: * Patients with other severe pain (e...

Countries:United StatesCanadaEstoniaRussia
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Competitive Landscape -Fibromyalgia 10 trials

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Axsome Therapeutics, Inc.AXSM2PHASE3AXS-14
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Frequently asked questions about Reboxetine

What is reboxetine used for?

Reboxetine has been studied in major depressive disorder, fibromyalgia, and pain. It is an investigational small molecule being developed by Pfizer, Inc. (NYSE: PFE). Clinical trials have evaluated it both as monotherapy and in combination with sertraline for major depression, and as a treatment for fibromyalgia and pain.

What does reboxetine target?

Reboxetine targets SLC6A2, the norepinephrine transporter. It acts as an inhibitor of this transporter. By inhibiting SLC6A2, reboxetine affects norepinephrine reuptake. This target class is consistent with its development in psychiatry and pain-related conditions.

Who is developing reboxetine?

Pfizer, Inc. (NYSE: PFE) is the developer of reboxetine. The company has sponsored clinical trials of the drug in major depressive disorder, fibromyalgia, and pain. Pfizer holds the ticker PFE on the New York Stock Exchange.

What phase is reboxetine in?

Reboxetine is in Phase 2 development overall. One completed trial of [S,S]-reboxetine in fibromyalgia was listed as Phase 3, but the drug is not approved and remains investigational. All three completed trials have finished, and no active trials are ongoing.

What clinical trials is reboxetine in?

Reboxetine has been studied in completed trials including NCT00636246, which compared sertraline-reboxetine combination therapy with sertraline or reboxetine monotherapy in major depression; NCT00612170, a 14-week fibromyalgia study; NCT00357825, a fibromyalgia pain trial; and NCT00288652, a dose-range finding trial in pain.

Is reboxetine the same as [S,S]-reboxetine?

Yes, [S,S]-reboxetine is an alternative name for reboxetine. Other names used in study titles include [S,S]-reboxetine monotherapy and reboxetine monotherapy. These refer to the same investigational compound developed by Pfizer for major depressive disorder, fibromyalgia, and pain.