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Sumatriptan · 2 trials · 2 indications
The primary objective for this study is to compare headache relief (defined as a reduction from moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\] or mild \[Grade 1\] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.
The pharmacokinetic parameters AUC0-∞ and Cmax of sumatriptan following the administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection. • The relative bioavailability (Frel) of sumatriptan following the nasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to 6 mg IMITREX® (sumatriptan) Subcutaneous Injection.
The relative bioavailability (Frel) of sumatriptan following the nasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to 6 mg IMITREX® (sumatriptan) Subcutaneous Injection.
| Arm | Type | Description |
|---|---|---|
| Sumatriptan | ACTIVE_COMPARATOR | - |
| Matching placebo | PLACEBO_COMPARATOR | - |
| Investigational | EXPERIMENTAL | OPTINOSE SUMATRIPTAN, single dose of 20 mg intranasally (10 mg to each nostril). |
| IMITREX Nasal Spray | ACTIVE_COMPARATOR | IMITREX® (sumatriptan) Nasal Spray, single dose of 20 mg intranasally (20 mg to one nostril). |
| IMITREX Oral Tablet | ACTIVE_COMPARATOR | IMITREX® (sumatriptan) Oral Tablet, single dose of 100 mg, administered orally with 240 mL water. |
| IMITREX Subcutaneous Injection | ACTIVE_COMPARATOR | IMITREX® (sumatriptan) Subcutaneous Injection, single dose of 6 mg injected subcutaneously in the abdomen. |
| Name | Type | Description |
|---|---|---|
| Sumatriptan | DRUG | Sumatriptan 20mg |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: * Men or women, between the ages of 18 to 65 years * Diagnosis of migraine, with or without aura * Experiences between 1 and 8 migraine attacks per month for the past 12 months Exclusion Criteria: * Inability to distinguish other headaches from migraine * Experiences headache ...
Sumatriptan is used for the acute treatment of migraine headache and migraine. It is being developed by OptiNose, Inc. as an intranasal powder delivered with a bi-directional device. The drug is a small molecule in the neurology therapeutic area and is currently in clinical development.
OptiNose, Inc. (NASDAQ: OPTN) is developing Sumatriptan. The company is conducting clinical trials to evaluate the safety and efficacy of a single dose of Sumatriptan powder delivered intranasally with the bi-directional device in adults with acute migraine.
Sumatriptan is in Phase 1 clinical development, based on a completed bioavailability study. However, a Phase 3 trial has also been completed, evaluating the safety and efficacy of a single dose in adults with acute migraine. The drug is investigational and not approved.
Sumatriptan has two completed clinical trials. NCT01462812 was a Phase 3 study of a single dose of Sumatriptan powder delivered intranasally with the bi-directional device in 223 adults with acute migraine. NCT01507610 was a Phase 1 bioavailability study comparing OptiNose Sumatriptan with Imitrex in 20 healthy subjects.
Sumatriptan is a small molecule that works as a selective serotonin receptor agonist, specifically targeting 5-HT1B and 5-HT1D receptors. This action constricts cranial blood vessels and inhibits the release of pro-inflammatory neuropeptides, which helps relieve migraine symptoms.
Sumatriptan is the active ingredient in Imitrex, but the OptiNose formulation is a unique intranasal powder delivered with a bi-directional device. A Phase 1 bioavailability study compared OptiNose Sumatriptan with Imitrex to assess how the two formulations compare in healthy subjects.