Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use : Use only if a clear diagnosis of migraine has been established ( 1 ) Not indicated for the preventive treatment of migraine ( 1 ) Not indicated for the treatment… FDA label
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 to treat migraine and migraine headache. OptiNose, Inc. is developing an intranasal powder formulation of sumatriptan delivered with a bi-directional device for adults with acute migraine. The drug is a small molecule in the neurology therapeutic area.
Sumatriptan targets HTR1B and HTR1D, where it acts as an agonist. These are serotonin receptor subtypes, and agonist activity at these receptors is the basis of its mechanism in migraine. The molecular target class for this asset is agonist.
OptiNose, Inc. (ticker OPTN) is developing the intranasal sumatriptan powder delivered with a bi-directional device. The company is the sponsor behind the clinical program evaluating this formulation in adults with acute migraine.
The program includes a completed Phase 1 bioavailability study and a completed Phase 3 safety and efficacy trial. The Phase 1 study compared OptiNose sumatriptan with IMITREX in healthy subjects. No active trials are currently listed for this asset.
Two completed trials are registered: NCT01507610, a Phase 1 bioavailability study comparing OptiNose sumatriptan with IMITREX in 20 healthy subjects, and NCT01462812, a Phase 3 safety and efficacy trial of a single intranasal dose in 223 adults with acute migraine. Both were conducted in the United States.
IMITREX is a brand of sumatriptan, so the two share the same active drug. The OptiNose asset is an investigational intranasal powder formulation delivered with a bi-directional device, which is a different delivery approach from the injectable and oral forms of sumatriptan.