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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 treatment of migraine and migraine headache. It is being developed by OptiNose, Inc. as a small molecule delivered intranasally using a bi-directional device for acute migraine relief. The drug is currently in clinical development and is not approved by the FDA.
Sumatriptan is being developed by OptiNose, Inc., a company traded under the ticker symbol OPTN. The company is conducting clinical trials to evaluate the safety and efficacy of an intranasal powder formulation of sumatriptan for the treatment of acute migraine.
Sumatriptan is in Phase 1 clinical development, according to the latest data. However, a completed Phase 3 trial has been conducted for the intranasal powder formulation. The drug is investigational and has not received FDA approval.
Sumatriptan has been studied in two completed clinical trials. NCT01462812 was a Phase 3 study evaluating a single dose of sumatriptan powder delivered intranasally in adults with acute migraine, enrolling 223 participants. NCT01507610 was a Phase 1 bioavailability study comparing OptiNose sumatriptan with Imitrex in healthy subjects, enrolling 20 participants.
Sumatriptan is the generic name of the drug, while Imitrex is a brand name for sumatriptan. In a Phase 1 study, OptiNose's intranasal sumatriptan was compared with Imitrex to assess bioavailability. The drug is being developed as an alternative delivery method for sumatriptan.