Methods for the administration of certain vmat2 inhibitors
OwnerGordon Loewen, Satjit Brarinventors
Life of this patent
Estimating the term…
Abstract
Provided is a method of treating a neurological or psychiatric disease or disorder in a patient in need thereof, comprising: administering a vesicular monoamine transporter 2 (VMAT2) inhibitor to the patient in need thereof wherein the patient is a CYP2D6 poor metabolizer.
Claims43
A method of treating a neurological or psychiatric disease or disorder in a patient in need thereof, comprising:
- administering a maximum total daily dose of between about 6 mg/day and about 30 mg/day of a vesicular monoamine transporter 2 (VMAT2) inhibitor to the patient in need thereof, wherein the patient a CYP2D6 poor metabolizer,
- wherein the VMAT2 inhibitor is (RR,SS)-1, 3, 4, 6, 7, 11b-hexahydro-9,10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one (deutetrabenazine),
- wherein the administering occurs outside of a clinical trial setting.
A method of treating a neurological or psychiatric disease or disorder in a patient in need thereof, comprising:
- administering to the patient a maximum total daily dose of deutetrabenazine, that is between about 6 mg/day and about 30 mg/day if, and because, the patient is a CYP2D6 poor metabolizer,
- wherein the administering occurs outside of a clinical trial setting.
A method of treating a neurological or psychiatric disease or disorder in a patient in need thereof, wherein the patient is a CYP2D6 poor metabolizer comprising:
- administering to the patient a maximum total daily dose of between 6 mg/day and about 30 mg/day of a vesicular monoamine transporter 2 (VMAT2) inhibitor,
- wherein the VMAT2 inhibitor is deutetrabenazine,
- monitoring the concentration of [−]-α-DHTBZ and/or [−]-β-DHTBZ in the patient's blood;
- and
- reducing the amount of the VMAT2 inhibitor being administered when the [−]-α-DHTBZ and/or [−]-β-DHTBZ exposure in the patient's blood is increased as compared with the [−]-α-DHTBZ and/or [−]-β-DHTBZ level in a patient who is administered the VMAT2 inhibitor alone,
- wherein the administering occurs outside of a clinical trial setting.
A method of treating a neurological or psychiatric disease or disorder in a patient in need thereof, comprising:
- administering about 48 mg/day of a vesicular monoamine transporter 2 (VMAT2) inhibitor to the patient in need thereof, wherein the VMAT2 inhibitor is deutetrabenazine,
- subsequently determining that the patient is a CYP2D6 poor metabolizer and
- administering a maximum total daily dose of between about 6 mg/day and about 30 mg/day of a vesicular monoamine transporter 2 (VMAT2) inhibitor to the patient in need thereof,
- wherein the administering occurs outside of a clinical trial setting.
A method of decreasing a risk of QT prolongation in a patient being treated for a neurological or psychiatric disease or disorder with deutetrabenazine, comprising:
- administering to the patient a maximum total daily dose of deutetrabenazine that is between about 6 mg/day and about 30 mg/day if, and because, the patient is a CYP2D6 poor metabolizer,
- wherein the administering occurs outside of a clinical trial setting.
A method of reducing off-target activity and increasing on-target activity in a patient being treated for a neurological or psychiatric disease or disorder with deutetrabenazine, comprising:
- administering to the patient a maximum total daily dose of deutetrabenazine that is between about 6 mg/day and about 30 mg/day if, and because, the patient is a CYP2D6 poor metabolizer,
- wherein the administering occurs outside of a clinical trial setting.
The method of any one of the preceding claims, wherein the patient has a CYP2D6 poor metabolizer genotype.
The method of any one of the preceding claims, wherein the neurological or psychiatric disease or disorder is a hyperkinetic movement disorder, mood disorder, bipolar disorder, schizophrenia, schizoaffective disorder, mania in mood disorder, depression in mood disorder, treatment-refractory obsessive compulsive disorder, neurological dysfunction associated with Lesch-Nyhan syndrome, agitation associated with Alzheimer's disease, Fragile X syndrome or Fragile X-associated tremor-ataxia syndrome, autism spectrum disorder, Rett syndrome, or chorea-acanthocytosis.
The method of any one of the preceding claims, wherein the maximum daily dose is about 24 mg.
The method of any one of the preceding claims, further comprising monitoring the patient for one or more exposure-related adverse reactions.
The method of any one of the preceding claims, further comprising reducing the amount of the VMAT2 inhibitor based on the patient's ability to tolerate one or more exposure-related adverse reactions.
The method of any one of the preceding claims, further comprising informing the patient or a medical care worker that administration of the VMAT2 inhibitor to a patient who is a CYP2D6 poor metabolizer may result in increased risk of one or more exposure-related adverse reactions.
The method of any one of the preceding claims, further comprising informing the patient or a medical care worker that administration of the VMAT2 inhibitor to a patient who is a CYP2D6 poor metabolizer may prolong the patient's QT interval.
The method of any one of the preceding claims, wherein the VMAT2 inhibitor is administered orally.
The method of any one of the preceding claims, wherein the VMAT2 inhibitor is administered in the form of a tablet or capsule.
Dependencies are inferred from the claim text.