Ketamine or dextromethorphan formulations and methods of use

Inventors

Pollard, Scott • Marshalek, Patrick • Matsumoto, Rae

Abstract

The present invention provides a method of treating depression disease in a treatment resistant patient comprising administering to a mucosal membrane of a patient an effective amount of a pharmaceutically acceptable composition comprising an effective amount of ketamine or dextromethorphan, wherein the mucosal administration of the ketamine or dextromethorphan containing composition allows for the mucosal absorption of the composition eliminating the digestive tract of the patient for effecting a rapid acting antidepressant treatment of the treatment resistant patient. This method includes administering the composition to a patient's mucosal membrane of a respiratory tract, a genitourinary tract, an oral tract, or rectal tract of the patient. A pharmaceutically acceptable composition comprising ketamine or dextromethorphan and a vehicle is disclosed. A biomarker for identifying a depressive disease is set forth.

Core Innovation

The described approach relates to treating depression in a treatment resistant patient by administering an effective amount of dextromethorphan to a mucosal membrane in an oral cavity. The composition provides transmucosal absorption of dextromethorphan into the patient’s systemic bloodstream while avoiding first-pass elimination of dextromethorphan from the digestive tract and liver. The approach is described as providing a twenty-four hour rapid acting antidepressant effect for treating depression in a treatment resistant patient.

The disclosure further describes mucosal, preferably buccal or oral, administration for achieving transmucosal absorption while avoiding digestive first-pass elimination. It also describes pharmaceutically acceptable compositions and vehicles for mucosal administration, including mucoadhesive-layer devices and buffered pH. The vehicles are described with mucoadhesive layers and water-erodible polymers intended to support administration and absorption through the oral mucosa.

In addition, the disclosure presents a biomarker concept intended to predict responsiveness using changes in acoustic vocal parameters and corticospinal excitability. The acoustic vocal parameters are described in terms of speech rate and voice frequency, and corticospinal excitability is described using resting motor threshold measurement with TMS. The biomarker framework is described in connection with evaluating responsiveness to the transbuccal ketamine versus oral dextromethorphan approach.

Claims Coverage

The partial content identifies one independent claim directed to a method of treating depression in a treatment resistant patient using mucosal administration of dextromethorphan to enable transmucosal absorption while avoiding first-pass elimination, and providing a twenty-four hour rapid acting antidepressant effect.

Across the identified independent claim, the central inventive concept is mucosal administration of dextromethorphan in the oral cavity to achieve transmucosal absorption into systemic bloodstream while avoiding digestive tract and liver first-pass elimination, to provide a twenty-four hour rapid acting antidepressant effect for a treatment resistant patient.

Stated Advantages

Documented Applications