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-Reboxetine

Phase 3

Fibromyalgia | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Dec 12, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment1,129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00612170A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.PHASE3 COMPLETED 1,129Dec 1, 2007May 1, 2009Dec 12, 2019145 United States, Canada
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Study Endpoints
Primary Endpoints
Change from baseline in the endpoint mean pain score
14 weeks
Fibromyalgia Impact Questionnaire
14 weeks
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 -
Interventions
NameTypeDescription
[S,S]-ReboxetineDRUG10 mg oral tablet once a day dosing
PlaceboDRUG0 mg oral tablet once a day dosing
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Eligibility Criteria
Age Range18 Years — 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 StatesCanada
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Competitive Landscape -Fibromyalgia 5 trials
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