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MSM

Phase 2

Nasal Breathing | Unknown | ENT |Medicus Pharma Ltd.|Last Updated: Jan 21, 2015

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02342483MSM Product on Attenuating Nasal Provocation With a Standardized Allergenic ChallengePHASE2 COMPLETED 15Jul 1, 2014Aug 1, 2014Jan 21, 2015 -
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Study Endpoints
Primary Endpoints
Peak Nasal Inspiratory Flow (PNIF)
14 days
VAS Nasal Symptom Score
14 days
Number of sneezes in response to allergen exposure
14 days
Number of used tissues in response to allergen exposure
14 days
Weight of used tissues in response to allergen exposure
14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
1gACTIVE_COMPARATORMETHYLSULFONYLMETHANE
3gACTIVE_COMPARATORMETHYLSULFONYLMETHANE
6gACTIVE_COMPARATORMETHYLSULFONYLMETHANE
Interventions
NameTypeDescription
MSMDIETARY_SUPPLEMENT -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy volunteers ≥ 18 and ≤ 65 years of age * Subjects with history of nasal congestion in response to pollen, dust mites, cat dander, and/or dog dander * Subjects who score "moderate" or "severe" on the VAS Nasal Symptom Score in response to an allergenic challenge at scree...

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