Magazine article Clinical Psychiatry News

Novel Intranasal Antidepressant Shows Results after 1 Week

Magazine article Clinical Psychiatry News

Novel Intranasal Antidepressant Shows Results after 1 Week

Article excerpt

AT THE NCDEU MEETING

HOLLYWOOD, FLA. -- An investigational intranasal spray antidepressant known as PH10 shows promise in addressing two major unmet needs in the treatment of major depressive disorder: faster-acting drugs with novel mechanisms of action.

PH10 showed a large antidepressant effect in a small phase II study after just 1 week, when the first scheduled assessment took place. Future studies will look for an antidepressant effect even sooner, perhaps as early as day 1 of treatment, Dr. Michael R. Liebowitz said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

PH10 is a proprietary pherine. The pherines are a class of intranasally administered psychoactive therapeutic agents that bind locally on nasal chemosensory receptors and trigger responses in the hypothalamus, amygdala, prefrontal cortex, and hippocampus. They have an excellent safety and tolerability profile, are effective in nanogram quantities, and do not circulate systemically in the blood. They initiate neural impulses that follow defined pathways to directly affect brain function, explained Dr. Liebowitz of Columbia University New York.

He presented an 8-week, phase II, double-blind, single-site pilot randomized trial of 30 patients with major depressive disorder. None had treatment-resistant depression. They were randomized to two self-administered inhalations in each nostril twice daily at 3.2 mcg/day of PH10 from a metered-dose spray device, or a high-dose group receiving 6. …

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