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Also known as Sumatriptan succinate injection
DFN-11 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| DFN-11 | EXPERIMENTAL | DFN-11 active injection upon occurrence of migraine |
| Placebo | PLACEBO_COMPARATOR | Placebo injection upon occurrence of migraine |
| Sumatriptan 3 mg then 6 mg | EXPERIMENTAL | DFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections |
| Sumatriptan 6 mg then 3 mg | EXPERIMENTAL | Two DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo |
| Name | Type | Description |
|---|---|---|
| DFN-11 | DRUG | - |
| Placebo | OTHER | - |
Inclusion Criteria: 1. If female, a subject must have a negative serum pregnancy test at screening, does not plan to become pregnant during the study, and is not lactating 2. If female, a subject also must have a negative urine pregnancy test at all subsequent study visits after the Screening Visit...
DFN-11 is an investigational small molecule being developed for the treatment of episodic migraine and rapidly escalating migraine. It is administered by injection and is currently in clinical development, having completed Phase 3 and Phase 2 trials for these indications.
DFN-11 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its ability to treat episodic migraine and rapidly escalating migraine, though the exact mechanism of action is not publicly detailed.
DFN-11 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials to evaluate the drug's safety and efficacy for migraine treatment.
DFN-11 has completed Phase 3 clinical development for episodic migraine, with a Phase 2 study also completed for rapidly escalating migraine. It remains an investigational drug and has not been approved by regulatory authorities for commercial use.
DFN-11 has been studied in two completed clinical trials. NCT02569853 was a Phase 3, randomized, double-blind, placebo-controlled study in 268 patients with episodic migraine. NCT02571049 was a Phase 2 pilot study in 24 patients with rapidly escalating migraine, testing two different strengths of the injection.
DFN-11 is a distinct investigational drug developed by Dr. Reddy's Laboratories. It is not known to be the same as any other marketed migraine medication, as its specific composition and mechanism have not been publicly compared to existing treatments.