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NP101 Sumatriptan Iontophoretic Patch

Phase 1

Migraine Disorders | Small molecule | Neurology |Teva Pharmaceutical Industries Limited|Last Updated: Feb 3, 2016

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment4
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00720018Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy VolunteersPHASE1 COMPLETED 4Jun 1, 2008Jul 1, 2008Feb 3, 20161 United States
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Study Endpoints
Primary Endpoints
The primary objective was to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers.
Blood samples were collected at time points: pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 16 hrs post-dose.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Period 1EXPERIMENTALNP101 Patch
Period 2EXPERIMENTALNP101 Patch
Period 3EXPERIMENTALNP101 Patch
Period 4EXPERIMENTALNP101 Patch
Period 5EXPERIMENTALNP101 Patch
Interventions
NameTypeDescription
NP101 Sumatriptan Iontophoretic Transdermal PatchDRUGNP101 transdermal patch delivering sumatriptan for 4 hours.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Caucasian men or women aged 18 to 45. * Subjects have BMI of 18 to 30 kg/m2 inclusive. * Subject judged to be in good health, based upon the results of a medical history, physical examination, vital signs, ECG and laboratory profile. Subjects will not have any clinical...

Countries:United States
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