FDA Completes Review Of Minerva Neurosciences' INDA For MIN-202

(RTTNews) - Minerva Neurosciences, Inc. (NERV) Monday said the U.S. Food and Drug Administration or FDA has completed its review of the company's Investigational New Drug Application or INDA for MIN-202, used for the treatment of insomnia.

The FDA indicated that the bioavailability study to advance development of MIN-202 shall be taken forward, thus making it the first clinical trial initiated for MIN-202 in the United States.

MIN-202 is being developed by Minerva Neurosciences in collaboration with Janssen Pharmaceutica N.V. and Janssen Research & Development, LLC.

The bioavailability study will include three separate trials, and will evaluate the bioavailability, food effect, safety and tolerability of solid dosage formulation of MIN-202 in healthy male subjects.