Acute migraine headache attacks are moderate-to-severe headaches that can cause pulsing or intense throbbing sensations in the head, and they are often accompanied by nausea, vomiting, and extreme sensitivity to light and sound.
A novel combination of sumatriptan and rapid release promethazine, CL-H1T is currently being investigated for treatment of acute migraine attacks and the prevention or reduction of Migraine-Associated Nausea and Vomiting (MANV).
A novel formulation of an undisclosed compound combined with an antiemetic.
Pre-Clinical research takes place before any human testing is done using animals to find out if a drug, procedure, or treatment is likely to be useful.
Phase 1 clinical trials are classified as early stage studies for up to 1 month in duration on 20-80 healthy volunteers to evaluate the safety, appropriate dose range, toxicity limits, and side effects of a new drug or treatment.
Phase 2 clinical trials are classified as late stage studies on 200 to 300 individuals for up to several months’ duration on patients with a specific targeted disease to further evaluate the safety, effectiveness, and short-term side effects of the new drug.
Phase 3 clinical trials are classified as final stage studies on hundreds to thousands of patients that can last several years to confirm safety and effectiveness compared to commonly used products, monitor side effects and obtain further data on secondary endpoints that will help the new drug be used safely.
The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.