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news.The US Food and Drug Administration (FDA) has completed its review of Minerva Neurosciences' investigational new drug (IND) application for MIN-202, the company's selective antagonist for the orexin-2 receptor being developed to treat insomnia.
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MIN-202 is being developed by Minerva Neurosciences in collaboration with Janssen Pharmaceutica and Janssen Research & Development.
The completion of the IND review will allow Janssen to start a bioavailability study in the US for investigational therapy MIN-202.
Minerva Neurosciences president and chief executive officer Rogerio Vivaldi said the company is happy that they are now in position to initiate the first US-based clinical trial for this promising compound.
"With the recent FDA approval of a dual orexin antagonist for the treatment of insomnia, we are especially encouraged by research indicating that our selective orexin antagonist may be positioned to offer improved specificity and a more adequate pharmacokinetics/pharmacodynamics profile," Vivaldi said.
The company said that the bioavailability study will be a randomized, open-label, three-way crossover trial in healthy male subjects to assess the bioavailability, food effect, safety and tolerability of solid dosage formulation of MIN-202.
Apart from this trial, Janssen is carrying out two other Phase I trials with MIN-202, including a Phase Ib trial in patients suffering from secondary insomnia and major depressive disorder and a randomized, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy male and female subjects.
The primary objective of the MAD trial is to evaluate pharmacokinetics data for several doses of MIN-202 after repeated administration as well as to explore the safety and tolerability of MIN-202 versus placebo during ten days of consecutive dose administration.