JP-2026076173-A - Multimodal composition and therapeutic method

Abstract

[Problem] To provide a method for administering diazepam using a multimodal delivery profile. [Solution] A method is provided for administering diazepam in a multimodal delivery profile, which includes delivering diazepam from a matrix and facilitating the permeation of at least some of the diazepam through mucosal tissue. [Selection Diagram] Figure 1A

Inventors

• アレクサンダー マーク ショベル
• ステファニー エム． バージャン
• ステファン ポール ワルガクキ
• ゲイリー サルトコ
• アレン エイチ． ヘラー

Assignees

• アクエスティブ セラピューティクス インコーポレイテッド

Dates

Publication Date

20260511

Application Date

20251225

Priority Date

20191114

Claims (20)

1. A method for administering diazepam in a multimodal delivery profile, comprising delivering diazepam from a matrix and facilitating the permeation of at least some of the diazepam through mucosal tissue.
2. The method according to claim 1, wherein the multimodal profile is a bimodal delivery profile.
3. The method according to claim 1, further comprising delivering a permeable enhancer from the matrix.
4. The method according to claim 1, wherein at least about 5-50% of diazepam is administered via the oral transmucosal route.
5. The method according to claim 1, wherein at least about 5% of diazepam is administered via the gastrointestinal route.
6. The method according to claim 1, wherein diazepam is administered as a prophylactic treatment.
7. The method according to claim 1, wherein diazepam is administered as an emergency treatment drug.
8. The method according to claim 1, wherein diazepam is administered to treat CNS disorders.
9. The method according to claim 1, wherein diazepam is administered to treat seizures.
10. The method according to claim 1, wherein diazepam is administered to treat generalized seizures.
11. The method according to claim 1, wherein diazepam is administered to treat a focal seizure.
12. The method according to claim 1, wherein diazepam is administered to treat a focal, pre-conscious seizure.
13. The method according to claim 1, wherein diazepam is administered to treat a focal impairment of consciousness seizure.
14. The method according to claim 1, wherein diazepam is administered to treat bilateral tonic seizures.
15. The method according to claim 1, wherein diazepam is administered to treat absence seizures.
16. The method according to claim 1, wherein diazepam is administered to treat atypical absence seizures.
17. The method according to claim 1, wherein diazepam is administered to treat tonic-clonic seizures.
18. The method according to claim 1, wherein diazepam is administered to treat cataplexy.
19. The method according to claim 1, wherein diazepam is administered to treat clonic seizures.
20. The method according to claim 1, wherein diazepam is administered to treat tonic seizures.

Description

(Claiming priority) This application claims priority to U.S. Provisional Application No. 62/935,460, filed on November 14, 2019, which is incorporated herein by reference in its entirety. (Technical field) The present invention relates to pharmaceutical compositions and therapeutic methods. (background) A seizure is a sudden, uncontrolled electrical disturbance in the brain. It can cause changes in behavior, actions, or emotions, and in the level of consciousness. If two or more seizures or a tendency toward recurrent seizures occur, the person is often diagnosed with epilepsy. Epilepsy is a neurological disorder characterized by sudden, frequent episodes of sensory disturbances, loss of consciousness, or convulsions associated with abnormal electrical activity in the brain. Benzodiazepines are often used to treat seizures. They are used to treat conditions such as anxiety disorders, insomnia, alcohol withdrawal disorders, and amnesia. They can also be used as muscle relaxants. They may be prescribed before anesthesia, such as before surgery. Some examples of benzodiazepines are alprazolam (Xanax), lorazepam (Ativan), chlordiazepoxide (Librium), and diazepam (Valium). Benzodiazepines can be used to treat CNS (central nervous system) disorders. (overview) Broadly speaking, a method of administering diazepam in a multimodal delivery profile may include delivering diazepam from a matrix and facilitating the permeation of at least some of the diazepam through mucosal tissue. In some embodiments, the multimodal profile may also be a bimodal delivery profile. In one embodiment, the method may further include delivering a permeable enhancer from the matrix. In one embodiment, at least about 5-50% of diazepam is administered via the oral mucosal route. In another embodiment, at least about 5% of diazepam is administered via the gastrointestinal route. In one embodiment, diazepam is administered as a prophylactic treatment. In one embodiment, diazepam can be administered as an emergency treatment drug. In one embodiment, diazepam can be administered to treat CNS disorders. In one embodiment, diazepam can be administered to treat seizures. In one embodiment, diazepam can be administered to treat generalized seizures. In one embodiment, diazepam can be administered to treat focal seizures. In another embodiment, diazepam can be administered to treat focal presbyopia. In one embodiment, diazepam can be administered to treat seizures of focal loss of consciousness. In one embodiment, diazepam can be administered to treat bilateral tonic seizures. In one embodiment, diazepam can be administered to treat absence seizures. In one embodiment, diazepam can be administered to treat atypical absence seizures. In one embodiment, diazepam can be administered to treat tonic-clonic seizures. In one embodiment, diazepam can be administered to treat cataplexy. In one embodiment, diazepam can be administered to treat clonic seizures. In one embodiment, diazepam can be administered to treat tonic seizures. In one embodiment, diazepam can be administered to treat myoclonic seizures. In one embodiment, diazepam can be administered to treat laughter and crying fits. In one embodiment, diazepam can be administered to treat febrile seizures. In one embodiment, diazepam can be administered to treat non-epileptic seizures. In one embodiment, diazepam can be administered to treat refractory seizures. In one embodiment, diazepam can be administered while the patient is eating food. In one embodiment, a method of administering diazepam includes adjusting the dose of diazepam to compensate for the food effect by increasing the dose to offset the food effect, so that the subject achieves a safe and effective dose while ingesting food. In one embodiment, diazepam is administered to a fasted patient. In one embodiment, approximately 2.5 to 30 mg of diazepam is delivered. In one embodiment, approximately 2.5 mg of diazepam is delivered as a single dose. In one embodiment, approximately 5 mg of diazepam is delivered as a single dose. In one embodiment, approximately 7.5 mg of diazepam is delivered as a single dose. In one embodiment, approximately 10 mg of diazepam is delivered as a single dose. In one embodiment, approximately 12.5 mg of diazepam is delivered as a single dose. In one embodiment, approximately 15 mg of diazepam is delivered as a single dose. In one embodiment, approximately 17.5 mg of diazepam is delivered as a single dose. In one embodiment, approximately 20 mg of diazepam is delivered as a single dose. In one embodiment, approximately 25 mg of diazepam is delivered as a single dose. In one embodiment, approximately 30 mg of diazepam is delivered as a single dose. In one embodiment, the dose of diazepam is administered according to a body weight-based regimen. In one embodiment, the matrix is a mucosal-adhering matrix. In one embodiment, diazepam is administered as a chewable tablet, gelatin, lyophilized, or inhalation-based dosage