Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sumatriptan · 1 trial · 1 indication
Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate \[Grade 2\] or severe \[Grade 3\] predose and reduced to none \[Grade 0\] postdose). Mild headache pain was recorded as Grade 1. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. If the subject experienced insufficient relief from the first dose of study medication, they were permitted to take a second dose of study medication or rescue medication 2 or more hours after the first dose, and only after completing the 2 hours' postdose assessments. If no relief was experienced from the first dose of study medication after 2 hours only rescue medication could be administered. Maximum 2 doses of study medication per 24 hours.
| Arm | Type | Description |
|---|---|---|
| DFN-02 | EXPERIMENTAL | Participants self-administered a single-dose of DFN-02 (sumatriptan 10-mg/100 μL nasal spray) intranasally within one hour of an acute migraine pain episode. |
| Placebo | OTHER | Participants self-administered a single-dose of DFN-02 placebo nasal spray matching DFN-02 intranasally within one hour of an acute migraine pain episode. |
| Name | Type | Description |
|---|---|---|
| Sumatriptan 10 mg Nasal Spray | DRUG | 100 μL nasal spray once |
| Sumatriptan Placebo Nasal Spray | OTHER | 100 μL nasal spray once |
Inclusion Criteria: 1. A history of episodic migraine who experience an average of 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache free time between migraine headaches 2. Patients who have migraine with o...
Sumatriptan is used for the treatment of migraine headaches. It is a small molecule being developed by Smith & Nephew SNATS, Inc. for this neurological condition. The drug is currently in Phase 2 clinical development, and it is being studied as a nasal spray formulation.
Sumatriptan is a small molecule that targets serotonin receptors, specifically the 5-HT1B and 5-HT1D receptor subtypes. By activating these receptors, it constricts cranial blood vessels and inhibits the release of pro-inflammatory neuropeptides, which helps to relieve migraine symptoms.
Sumatriptan is being developed by Smith & Nephew SNATS, Inc., a company listed on the stock exchange under the ticker symbol SNN. The company is conducting clinical trials to evaluate the efficacy and safety of sumatriptan for the treatment of migraine headaches.
Sumatriptan is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 2 trial has been completed, and the results will inform further development of the drug for migraine headaches.
Sumatriptan has been studied in one clinical trial with the identifier NCT02856802. This Phase 2 trial, titled 'An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)', was a randomized, double-blind, controlled study that enrolled 107 participants with migraine headaches in the United States.
Yes, Sumatriptan is the same as DFN-02. The clinical trial NCT02856802 refers to the drug as DFN-02, which is a sumatriptan nasal spray formulation containing 10 mg of the active ingredient. This formulation is being developed for the treatment of migraine headaches.