IP Library Patent Application 16474083
Patent Application
App. No. 16/474,083

METHODS AND DEVICES FOR TREATING LEVODOPA INDUCED DYSKINESIA

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Quick Facts
Patent No.
US None
App. No.
16/474,083
Abstract

A method of delivering nicotine to treat dyskinesia, such as Levodopa induced dyskinesia (LID), includes delivering a first dose of nicotine to a patient using a transdermal delivery device and delivering a second dose of nicotine to the patient using the transdermal delivery device. The first and second doses are timed such that a refractory period between peak plasma levels of nicotine in the patient prevents desensitization of nicotinic acetylcholine receptors while reducing symptoms of LID.

Claims (36)

1 . A method of delivering nicotine to treat Levodopa induced dyskinesia (LID), the method comprising:

delivering a first dose of nicotine to a patient using a transdermal delivery device; and delivering a second dose of nicotine to the patient using the transdermal delivery device, the first and second doses timed such that a refractory period between peak plasma levels of nicotine in the patient prevents desensitization of nicotinic acetylcholine receptors while reducing symptoms of LID.

2 . The method of claim 1 , wherein the first and second doses are delivered within 24 hours.

3 . The method of claim 2 , further comprising repeating the delivery of first and second doses for at least one month.

4 . The method of claim 2 , wherein a total amount of nicotine delivered in the 24 hours is between 20 and 30 mg.

5 . The method of claim 2 , wherein only two doses of nicotine are delivered in the 24 hours so as to create a two-peak concentration profile over the 24 hours.

6 . The method of claim 1 , wherein the refractory period is between 5 hours and 15 hours.

7 . The method of claim 1 , wherein the refractory period is between 10 and 12 hours.

8 . The method of claim 1 , wherein the first dose includes multiple boluses administered within one hour.

9 . The method of claim 8 , wherein there are three boluses, and wherein each bolus includes between 70 and 80 μL of nicotine formulation.

10 . The method of claim 1 , wherein a peak to trough ratio at the refractory period is between 10 and 80.

11 . The method of claim 1 , wherein a peak to trough ratio at the refractory period is between 15 and 30.

12 . The method of claim 1 , wherein the symptoms of LID are reduced by at least 30%.

13 . The method of claim 1 , wherein the symptoms of LID include tremors, headache, changes in motor function, changes in mental status, changes in sensor functions, seizures, insomnia, paresthesia, and/or dizziness.

14 . The method of claim 1 , wherein the nicotine is delivered as a combination therapy.

15 . The method of claim 14 , wherein the nicotine is delivered as a combination therapy with amantadine, memantine, donepezil, levodopa or carbidopa, any other dopamine agonist, apomorphine, rotigotine, rasagaline, anticholinergics, MAO-B Inhibitors, COMT inhibitors, pramipexole, ropinirole, piribedil, cabergoline, lisuride, selegiline, bromocriptine, pergolide, or safinamide.

16 .- 35 . (canceled)

36 . A transdermal delivery device comprising:

a formulation reservoir configured to hold a nicotine formulation therein;

a transdermal membrane configured to deliver the nicotine formulation from the reservoir to the patient; and

a sensor configured to detect one or more symptoms associated with Levodopa induced dyskinesia (LID).

37 . The device of claim 36 , wherein the sensor is an accelerometer, gyroscope, magnetometer, or barometric sensor.

38 . The device of claim 36 , wherein the symptoms of LID include tremors, headache, changes in motor function, changes in mental status, changes in sensor functions, seizures, insomnia, paresthesia, and/or dizziness.

39 . The device of claim 36 , further comprising a controller, the controller configured to:

gather data from the sensor;

analyze the data to determine a severity of the one or more symptoms of LID; and

if the severity of symptoms is over a set amount, then increase a dosage protocol for the nicotine formulation.

40 . The device of claim 36 , further comprising a controller, the controller configured to:

gather data from the sensor;

analyze the data to determine a timing of the one or more symptoms of LID;

if the timing of the one or more symptoms of LID is offset from peak nicotine concentration times in a patient using the transdermal delivery device, then adjust a dosage protocol for the nicotine formulation so as to shift the set peak times to more closely overlap with the timing of the one or more symptoms.

41 . The device of claim 36 , further comprising a dispensing mechanism configured to deliver a plurality of boluses of nicotine formulation from the formulation reservoir to the transdermal membrane.

42 . The device of claim 36 , wherein the device has structure enabling removal of solvent from the transdermal membrane.

43 . The device of claim 36 , further comprising a controller, the controller configured to:

deliver a first dose of the nicotine formulation to a patient using the transdermal delivery device; and

deliver a second dose of nicotine to the patient, the first and second doses timed such that a refractory period between peak plasma levels of nicotine in the patient prevents desensitization of nicotinic acetylcholine receptors while reducing symptoms of LID.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2021
From: CTI (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
To: MORNINGSIDE VENTURE INVESTMENTS LIMITED
Reel/Frame 055382/0388 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2021
From: CHRONO THERAPEUTICS, INC.
To: CTI (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
Reel/Frame 055384/0227 →