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NP101 Sumatriptan Iontophoretic Patch

Phase 3

Migraine Disorders | Small molecule | Neurology |Teva Pharmaceutical Industries Limited|Trials Updated: Feb 4, 2016

NP101 Sumatriptan Iontophoretic Patch target and mechanism

ModalitySmall molecule

Also known as NP101 Sumatriptan Iontophoretic Transdermal Patch

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment534

FDA Designations

No designations recorded

NP101 Sumatriptan Iontophoretic Patch clinical trials

NP101 Sumatriptan Iontophoretic Patch · 2 trials · 1 indication

Phase 3 1Phase 1 1
NCT00724815The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute MigraineMigraine Disorders
COMPLETED530 Analytics
PHASE3COMPLETED
The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine
Migraine DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Pain Free at Two Hours
2 hours post patch activation

Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.

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.

Secondary Endpoints

Photophobia Free at Two Hours
2 hours post patch activation
Phonophobia Free at Two Hours
2 hours post patch activation
Nausea Free at Two Hours
2 hours post patch activation
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SumatriptanEXPERIMENTALNP101 - sumatriptan iontophoretic transdermal patch
PlaceboPLACEBO_COMPARATORPlacebo iontophoretic transdermal patch
Period 1EXPERIMENTALNP101 Patch
Period 2EXPERIMENTALNP101 Patch
Period 3EXPERIMENTALNP101 Patch
Period 4EXPERIMENTALNP101 Patch
Period 5EXPERIMENTALNP101 Patch

Interventions

NameTypeDescription
NP101 - Sumatriptan iontophoretic transdermal patchDRUGSumatriptan iontophoretic transdermal patch
PlaceboDRUGNP101 Placebo iontophoretic transdermal patch
NP101 Sumatriptan Iontophoretic Transdermal PatchDRUGNP101 transdermal patch delivering sumatriptan for 4 hours.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Subject is an adult male or female, age range 18 years to 65 years. * Subject has a diagnosis of migraine headache, with or without aura, as defined in the ICDH-II and the diagnosis was made before the age of 50. * Subject typically experiences moderate to severe headaches dur...

Countries:United States
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Frequently asked questions about NP101 Sumatriptan Iontophoretic Patch

What is NP101 Sumatriptan Iontophoretic Patch used for?

NP101 Sumatriptan Iontophoretic Patch is being developed for the treatment of acute migraine disorders. It is a transdermal patch formulation of sumatriptan designed to deliver the drug through the skin using iontophoresis. The patch is intended for adults with migraine.

How does NP101 Sumatriptan Iontophoretic Patch work?

NP101 Sumatriptan Iontophoretic Patch uses iontophoresis to deliver sumatriptan, a small molecule, through the skin. Iontophoresis applies a low electrical current to drive charged drug molecules across the skin barrier. Sumatriptan is a serotonin receptor agonist that treats acute migraine.

Who is developing NP101 Sumatriptan Iontophoretic Patch?

NP101 Sumatriptan Iontophoretic Patch is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is a global pharmaceutical company focused on generic and specialty medicines, including treatments for neurological conditions such as migraine.

What phase is NP101 Sumatriptan Iontophoretic Patch in?

NP101 Sumatriptan Iontophoretic Patch is in Phase 3 clinical development. It has not been approved by the FDA and remains an investigational therapy. The Phase 3 program includes a completed efficacy and tolerability trial in acute migraine.

What clinical trials is NP101 Sumatriptan Iontophoretic Patch in?

NP101 Sumatriptan Iontophoretic Patch has been studied in two completed clinical trials: NCT00724815, a Phase 3 efficacy and tolerability trial in acute migraine with 530 participants, and NCT00720018, a Phase 1 pharmacokinetic study in 4 healthy volunteers. Both trials were conducted in the United States.

Is NP101 Sumatriptan Iontophoretic Patch the same as NP101 Sumatriptan Iontophoretic Transdermal Patch?

Yes, NP101 Sumatriptan Iontophoretic Patch is also known as NP101 Sumatriptan Iontophoretic Transdermal Patch, NP101 - Sumatriptan iontophoretic transdermal patch, and NP101- Sumatriptan iontophoretic patch. These names refer to the same investigational product developed by Teva for acute migraine.