WO2024145545A2 - Procédés d'administration de solriamfétol à des femmes en lactation - Google Patents
Procédés d'administration de solriamfétol à des femmes en lactation Download PDFInfo
- Publication number
- WO2024145545A2 WO2024145545A2 PCT/US2023/086351 US2023086351W WO2024145545A2 WO 2024145545 A2 WO2024145545 A2 WO 2024145545A2 US 2023086351 W US2023086351 W US 2023086351W WO 2024145545 A2 WO2024145545 A2 WO 2024145545A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- solriamfetol
- subject
- infant
- breast milk
- mother
- Prior art date
Links
- UCTRAOBQFUDCSR-SECBINFHSA-N [(2r)-2-amino-3-phenylpropyl] carbamate Chemical compound NC(=O)OC[C@H](N)CC1=CC=CC=C1 UCTRAOBQFUDCSR-SECBINFHSA-N 0.000 title claims abstract description 457
- 229940070119 solriamfetol Drugs 0.000 title claims abstract description 443
- 238000000034 method Methods 0.000 title claims abstract description 329
- 235000020256 human milk Nutrition 0.000 claims abstract description 234
- 210000004251 human milk Anatomy 0.000 claims abstract description 234
- 230000002411 adverse Effects 0.000 claims abstract description 53
- 230000003247 decreasing effect Effects 0.000 claims abstract description 23
- 206010041349 Somnolence Diseases 0.000 claims description 89
- 208000007590 Disorders of Excessive Somnolence Diseases 0.000 claims description 77
- 230000002829 reductive effect Effects 0.000 claims description 76
- 201000003631 narcolepsy Diseases 0.000 claims description 75
- 208000001797 obstructive sleep apnea Diseases 0.000 claims description 72
- 230000035611 feeding Effects 0.000 claims description 70
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 63
- 208000018737 Parkinson disease Diseases 0.000 claims description 55
- 208000010877 cognitive disease Diseases 0.000 claims description 49
- 206010001497 Agitation Diseases 0.000 claims description 48
- 208000028698 Cognitive impairment Diseases 0.000 claims description 48
- 238000013019 agitation Methods 0.000 claims description 48
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 claims description 43
- 206010022437 insomnia Diseases 0.000 claims description 43
- 230000004584 weight gain Effects 0.000 claims description 43
- 235000019786 weight gain Nutrition 0.000 claims description 43
- 208000035475 disorder Diseases 0.000 claims description 41
- 208000036864 Attention deficit/hyperactivity disease Diseases 0.000 claims description 38
- 208000015802 attention deficit-hyperactivity disease Diseases 0.000 claims description 38
- 235000013336 milk Nutrition 0.000 claims description 36
- 239000008267 milk Substances 0.000 claims description 36
- 210000004080 milk Anatomy 0.000 claims description 36
- 208000022531 anorexia Diseases 0.000 claims description 33
- 206010061428 decreased appetite Diseases 0.000 claims description 33
- 208000014679 binge eating disease Diseases 0.000 claims description 31
- 208000006096 Attention Deficit Disorder with Hyperactivity Diseases 0.000 claims description 30
- 238000011282 treatment Methods 0.000 claims description 25
- 230000009467 reduction Effects 0.000 claims description 23
- 208000033914 shift work type circadian rhythm sleep disease Diseases 0.000 claims description 22
- 230000000474 nursing effect Effects 0.000 claims description 17
- 230000001186 cumulative effect Effects 0.000 claims description 16
- 206010062519 Poor quality sleep Diseases 0.000 claims description 14
- 208000032140 Sleepiness Diseases 0.000 claims description 13
- 230000037321 sleepiness Effects 0.000 claims description 13
- 230000008030 elimination Effects 0.000 claims description 12
- 238000003379 elimination reaction Methods 0.000 claims description 12
- 230000008774 maternal effect Effects 0.000 claims description 12
- 206010040981 Sleep attacks Diseases 0.000 claims description 11
- 230000033001 locomotion Effects 0.000 claims description 4
- 230000004580 weight loss Effects 0.000 claims description 4
- 239000003814 drug Substances 0.000 description 60
- 229940079593 drug Drugs 0.000 description 51
- 150000001875 compounds Chemical class 0.000 description 22
- 201000010099 disease Diseases 0.000 description 22
- 238000002565 electrocardiography Methods 0.000 description 17
- 239000003795 chemical substances by application Substances 0.000 description 14
- 230000000694 effects Effects 0.000 description 14
- 239000000203 mixture Substances 0.000 description 13
- 238000012216 screening Methods 0.000 description 13
- 230000006651 lactation Effects 0.000 description 11
- 238000004458 analytical method Methods 0.000 description 10
- 230000036470 plasma concentration Effects 0.000 description 10
- 206010019233 Headaches Diseases 0.000 description 9
- 230000036772 blood pressure Effects 0.000 description 9
- 230000008859 change Effects 0.000 description 9
- 231100000869 headache Toxicity 0.000 description 9
- 210000004369 blood Anatomy 0.000 description 8
- 239000008280 blood Substances 0.000 description 8
- 229940124597 therapeutic agent Drugs 0.000 description 8
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 7
- 230000002159 abnormal effect Effects 0.000 description 7
- 230000007958 sleep Effects 0.000 description 7
- 208000024891 symptom Diseases 0.000 description 7
- 239000003826 tablet Substances 0.000 description 7
- 210000000481 breast Anatomy 0.000 description 6
- 238000009533 lab test Methods 0.000 description 6
- 238000012544 monitoring process Methods 0.000 description 6
- 206010010144 Completed suicide Diseases 0.000 description 5
- 208000012902 Nervous system disease Diseases 0.000 description 5
- 235000021152 breakfast Nutrition 0.000 description 5
- 230000007423 decrease Effects 0.000 description 5
- 208000002173 dizziness Diseases 0.000 description 5
- 238000011156 evaluation Methods 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- 238000005259 measurement Methods 0.000 description 5
- 210000000056 organ Anatomy 0.000 description 5
- 238000011160 research Methods 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- 230000001225 therapeutic effect Effects 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 102100036475 Alanine aminotransferase 1 Human genes 0.000 description 4
- 108010082126 Alanine transaminase Proteins 0.000 description 4
- 102000009027 Albumins Human genes 0.000 description 4
- 108010088751 Albumins Proteins 0.000 description 4
- 108020004774 Alkaline Phosphatase Proteins 0.000 description 4
- 102000002260 Alkaline Phosphatase Human genes 0.000 description 4
- 230000036760 body temperature Effects 0.000 description 4
- 230000037396 body weight Effects 0.000 description 4
- 239000011575 calcium Substances 0.000 description 4
- 229910002092 carbon dioxide Inorganic materials 0.000 description 4
- 239000001569 carbon dioxide Substances 0.000 description 4
- 230000035487 diastolic blood pressure Effects 0.000 description 4
- 210000000265 leukocyte Anatomy 0.000 description 4
- 239000011734 sodium Substances 0.000 description 4
- 208000020925 Bipolar disease Diseases 0.000 description 3
- 208000001573 Cataplexy Diseases 0.000 description 3
- 241000700159 Rattus Species 0.000 description 3
- 206010042458 Suicidal ideation Diseases 0.000 description 3
- 230000005856 abnormality Effects 0.000 description 3
- 238000009825 accumulation Methods 0.000 description 3
- 230000004071 biological effect Effects 0.000 description 3
- 238000004820 blood count Methods 0.000 description 3
- 238000009530 blood pressure measurement Methods 0.000 description 3
- 210000003169 central nervous system Anatomy 0.000 description 3
- 238000007635 classification algorithm Methods 0.000 description 3
- 230000007407 health benefit Effects 0.000 description 3
- 238000009532 heart rate measurement Methods 0.000 description 3
- 238000001990 intravenous administration Methods 0.000 description 3
- 230000000670 limiting effect Effects 0.000 description 3
- 235000012054 meals Nutrition 0.000 description 3
- 239000000546 pharmaceutical excipient Substances 0.000 description 3
- 230000002035 prolonged effect Effects 0.000 description 3
- 238000011084 recovery Methods 0.000 description 3
- 230000036387 respiratory rate Effects 0.000 description 3
- 230000000284 resting effect Effects 0.000 description 3
- 210000002966 serum Anatomy 0.000 description 3
- 201000002859 sleep apnea Diseases 0.000 description 3
- 230000001839 systemic circulation Effects 0.000 description 3
- 230000035488 systolic blood pressure Effects 0.000 description 3
- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- 108010003415 Aspartate Aminotransferases Proteins 0.000 description 2
- 102000004625 Aspartate Aminotransferases Human genes 0.000 description 2
- BPYKTIZUTYGOLE-IFADSCNNSA-N Bilirubin Chemical compound N1C(=O)C(C)=C(C=C)\C1=C\C1=C(C)C(CCC(O)=O)=C(CC2=C(C(C)=C(\C=C/3C(=C(C=C)C(=O)N\3)C)N2)CCC(O)=O)N1 BPYKTIZUTYGOLE-IFADSCNNSA-N 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 2
- 241001678559 COVID-19 virus Species 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 241000283707 Capra Species 0.000 description 2
- 208000019888 Circadian rhythm sleep disease Diseases 0.000 description 2
- 241000283086 Equidae Species 0.000 description 2
- 241000282326 Felis catus Species 0.000 description 2
- 208000001640 Fibromyalgia Diseases 0.000 description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
- 241000282412 Homo Species 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 208000016588 Idiopathic hypersomnia Diseases 0.000 description 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
- 241000124008 Mammalia Species 0.000 description 2
- 241000699670 Mus sp. Species 0.000 description 2
- 241000208125 Nicotiana Species 0.000 description 2
- 235000002637 Nicotiana tabacum Nutrition 0.000 description 2
- 241000283973 Oryctolagus cuniculus Species 0.000 description 2
- 208000002193 Pain Diseases 0.000 description 2
- 241001494479 Pecora Species 0.000 description 2
- 241000009328 Perro Species 0.000 description 2
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 2
- 241000283984 Rodentia Species 0.000 description 2
- 241000282887 Suidae Species 0.000 description 2
- PNNCWTXUWKENPE-UHFFFAOYSA-N [N].NC(N)=O Chemical compound [N].NC(N)=O PNNCWTXUWKENPE-UHFFFAOYSA-N 0.000 description 2
- 238000013103 analytical ultracentrifugation Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000004638 bioanalytical method Methods 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 238000004364 calculation method Methods 0.000 description 2
- 230000035606 childbirth Effects 0.000 description 2
- 239000000460 chlorine Substances 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- ZPUCINDJVBIVPJ-LJISPDSOSA-N cocaine Chemical compound O([C@H]1C[C@@H]2CC[C@@H](N2C)[C@H]1C(=O)OC)C(=O)C1=CC=CC=C1 ZPUCINDJVBIVPJ-LJISPDSOSA-N 0.000 description 2
- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 description 2
- 230000034994 death Effects 0.000 description 2
- 231100000517 death Toxicity 0.000 description 2
- 230000002939 deleterious effect Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 239000003937 drug carrier Substances 0.000 description 2
- 239000000839 emulsion Substances 0.000 description 2
- 206010016256 fatigue Diseases 0.000 description 2
- 235000012631 food intake Nutrition 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000008103 glucose Substances 0.000 description 2
- 230000005764 inhibitory process Effects 0.000 description 2
- 238000007917 intracranial administration Methods 0.000 description 2
- 238000007918 intramuscular administration Methods 0.000 description 2
- 238000007912 intraperitoneal administration Methods 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 238000007726 management method Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000002483 medication Methods 0.000 description 2
- 229960002715 nicotine Drugs 0.000 description 2
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 description 2
- 235000015097 nutrients Nutrition 0.000 description 2
- 235000016709 nutrition Nutrition 0.000 description 2
- 230000036961 partial effect Effects 0.000 description 2
- 230000002085 persistent effect Effects 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 239000011591 potassium Substances 0.000 description 2
- 229910052700 potassium Inorganic materials 0.000 description 2
- 230000035935 pregnancy Effects 0.000 description 2
- 230000002028 premature Effects 0.000 description 2
- 238000011321 prophylaxis Methods 0.000 description 2
- 235000018102 proteins Nutrition 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 208000020016 psychiatric disease Diseases 0.000 description 2
- 238000005086 pumping Methods 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 208000019116 sleep disease Diseases 0.000 description 2
- 208000020685 sleep-wake disease Diseases 0.000 description 2
- 229910052708 sodium Inorganic materials 0.000 description 2
- 239000003381 stabilizer Substances 0.000 description 2
- 238000007920 subcutaneous administration Methods 0.000 description 2
- 238000011287 therapeutic dose Methods 0.000 description 2
- 238000002562 urinalysis Methods 0.000 description 2
- 210000002700 urine Anatomy 0.000 description 2
- OBHRVMZSZIDDEK-UHFFFAOYSA-N urobilinogen Chemical compound CCC1=C(C)C(=O)NC1CC1=C(C)C(CCC(O)=O)=C(CC2=C(C(C)=C(CC3C(=C(CC)C(=O)N3)C)N2)CCC(O)=O)N1 OBHRVMZSZIDDEK-UHFFFAOYSA-N 0.000 description 2
- 230000002861 ventricular Effects 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 206010006326 Breath odour Diseases 0.000 description 1
- 208000025721 COVID-19 Diseases 0.000 description 1
- 229940022962 COVID-19 vaccine Drugs 0.000 description 1
- 244000025254 Cannabis sativa Species 0.000 description 1
- 235000012766 Cannabis sativa ssp. sativa var. sativa Nutrition 0.000 description 1
- 235000012765 Cannabis sativa ssp. sativa var. spontanea Nutrition 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- 208000000094 Chronic Pain Diseases 0.000 description 1
- 102000004420 Creatine Kinase Human genes 0.000 description 1
- 108010042126 Creatine kinase Proteins 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 208000025966 Neurological disease Diseases 0.000 description 1
- IOVCWXUNBOPUCH-UHFFFAOYSA-M Nitrite anion Chemical compound [O-]N=O IOVCWXUNBOPUCH-UHFFFAOYSA-M 0.000 description 1
- 208000008589 Obesity Diseases 0.000 description 1
- 206010033645 Pancreatitis Diseases 0.000 description 1
- 241000233805 Phoenix Species 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- 208000005793 Restless legs syndrome Diseases 0.000 description 1
- 201000001880 Sexual dysfunction Diseases 0.000 description 1
- LEHOTFFKMJEONL-UHFFFAOYSA-N Uric Acid Chemical compound N1C(=O)NC(=O)C2=C1NC(=O)N2 LEHOTFFKMJEONL-UHFFFAOYSA-N 0.000 description 1
- TVWHNULVHGKJHS-UHFFFAOYSA-N Uric acid Natural products N1C(=O)NC(=O)C2NC(=O)NC21 TVWHNULVHGKJHS-UHFFFAOYSA-N 0.000 description 1
- 206010046543 Urinary incontinence Diseases 0.000 description 1
- KAOVAAHCFNYXNJ-SBSPUUFOSA-N [(2r)-2-amino-3-phenylpropyl] carbamate;hydrochloride Chemical compound Cl.NC(=O)OC[C@H](N)CC1=CC=CC=C1 KAOVAAHCFNYXNJ-SBSPUUFOSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 208000005298 acute pain Diseases 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 230000001430 anti-depressive effect Effects 0.000 description 1
- 230000000561 anti-psychotic effect Effects 0.000 description 1
- 239000000935 antidepressant agent Substances 0.000 description 1
- 229940005513 antidepressants Drugs 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 239000000164 antipsychotic agent Substances 0.000 description 1
- 229940005529 antipsychotics Drugs 0.000 description 1
- 238000007486 appendectomy Methods 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 229940125717 barbiturate Drugs 0.000 description 1
- 229940049706 benzodiazepine Drugs 0.000 description 1
- 150000001557 benzodiazepines Chemical class 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 201000001883 cholelithiasis Diseases 0.000 description 1
- 235000012000 cholesterol Nutrition 0.000 description 1
- 235000019506 cigar Nutrition 0.000 description 1
- 235000019504 cigarettes Nutrition 0.000 description 1
- 230000002060 circadian Effects 0.000 description 1
- 229960003920 cocaine Drugs 0.000 description 1
- 230000002301 combined effect Effects 0.000 description 1
- 229940124301 concurrent medication Drugs 0.000 description 1
- 229940109239 creatinine Drugs 0.000 description 1
- 229940127089 cytotoxic agent Drugs 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 1
- 239000000221 dopamine uptake inhibitor Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 206010013663 drug dependence Diseases 0.000 description 1
- 238000007877 drug screening Methods 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 210000000232 gallbladder Anatomy 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 208000024798 heartburn Diseases 0.000 description 1
- 208000012285 hip pain Diseases 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 206010020765 hypersomnia Diseases 0.000 description 1
- 229960001680 ibuprofen Drugs 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000000977 initiatory effect Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000007919 intrasynovial administration Methods 0.000 description 1
- 238000007913 intrathecal administration Methods 0.000 description 1
- 238000007914 intraventricular administration Methods 0.000 description 1
- 150000002576 ketones Chemical class 0.000 description 1
- 108010000849 leukocyte esterase Proteins 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 238000001294 liquid chromatography-tandem mass spectrometry Methods 0.000 description 1
- 239000007937 lozenge Substances 0.000 description 1
- 210000002751 lymph Anatomy 0.000 description 1
- 230000003050 macronutrient Effects 0.000 description 1
- 235000021073 macronutrients Nutrition 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 208000024714 major depressive disease Diseases 0.000 description 1
- TTWJBBZEZQICBI-UHFFFAOYSA-N metoclopramide Chemical compound CCN(CC)CCNC(=O)C1=CC(Cl)=C(N)C=C1OC TTWJBBZEZQICBI-UHFFFAOYSA-N 0.000 description 1
- 229960004503 metoclopramide Drugs 0.000 description 1
- 201000006417 multiple sclerosis Diseases 0.000 description 1
- 208000031225 myocardial ischemia Diseases 0.000 description 1
- 230000000926 neurological effect Effects 0.000 description 1
- 230000000422 nocturnal effect Effects 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 239000002767 noradrenalin uptake inhibitor Substances 0.000 description 1
- 229940127221 norepinephrine reuptake inhibitor Drugs 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 235000020824 obesity Nutrition 0.000 description 1
- 229940127240 opiate Drugs 0.000 description 1
- 229940127234 oral contraceptive Drugs 0.000 description 1
- 239000003539 oral contraceptive agent Substances 0.000 description 1
- 229960005489 paracetamol Drugs 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- JTJMJGYZQZDUJJ-UHFFFAOYSA-N phencyclidine Chemical compound C1CCCCN1C1(C=2C=CC=CC=2)CCCCC1 JTJMJGYZQZDUJJ-UHFFFAOYSA-N 0.000 description 1
- 229950010883 phencyclidine Drugs 0.000 description 1
- 239000002953 phosphate buffered saline Substances 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 231100000279 safety data Toxicity 0.000 description 1
- 230000001624 sedative effect Effects 0.000 description 1
- 231100000872 sexual dysfunction Toxicity 0.000 description 1
- 235000011888 snacks Nutrition 0.000 description 1
- XYGBKMMCQDZQOZ-UHFFFAOYSA-M sodium;4-hydroxybutanoate Chemical compound [Na+].OCCCC([O-])=O XYGBKMMCQDZQOZ-UHFFFAOYSA-M 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000021 stimulant Substances 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 208000011117 substance-related disease Diseases 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000007910 systemic administration Methods 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 210000001685 thyroid gland Anatomy 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 150000003626 triacylglycerols Chemical class 0.000 description 1
- 238000009810 tubal ligation Methods 0.000 description 1
- 206010045458 umbilical hernia Diseases 0.000 description 1
- 229940116269 uric acid Drugs 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 238000009528 vital sign measurement Methods 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- 229940051225 xyrem Drugs 0.000 description 1
Abstract
Selon certains modes de réalisation, l'invention concerne un procédé destiné à diminuer le potentiel d'événements indésirables causés par du solriamfétol dans un lait maternel, ingéré par un nourrisson, obtenu d'un sujet traité avec du solriamfétol comprenant : l'administration orale du solriamfétol au sujet à une dose quotidienne d'environ 37,5 mg à environ 300 mg ; et l'ingestion du lait maternel infantile du sujet au moins environ 5 heures après l'administration du solriamfétol au sujet, ce qui permet de diminuer le potentiel d'événements indésirables causés par du solriamfétol chez un nourrisson.
Applications Claiming Priority (11)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US18/148,682 | 2022-12-30 | ||
| US18/176,860 | 2023-03-01 | ||
| US18/176,855 | 2023-03-01 | ||
| US18/176,816 | 2023-03-01 | ||
| US18/323,229 | 2023-05-24 | ||
| US18/323,236 | 2023-05-24 | ||
| US18/323,232 | 2023-05-24 | ||
| US18/491,291 | 2023-10-20 | ||
| US18/491,319 | 2023-10-20 | ||
| US18/491,311 | 2023-10-20 | ||
| US18/491,301 | 2023-10-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2024145545A2 true WO2024145545A2 (fr) | 2024-07-04 |
Family
ID=
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US11110074B2 (en) | Methods of improving the pharmacokinetics of doxepin | |
| US6407128B1 (en) | Method for increasing the bioavailability of metaxalone | |
| EP3720433B1 (fr) | Bis-choline tétrathiomolybdate pour le traitement de la maladie de wilson | |
| CN115192575A (zh) | 使用芬氟拉明治疗Lennox-Gastaut综合征的方法 | |
| US11419832B2 (en) | Bis-choline tetrathiomolybdate for treating Wilson Disease | |
| US11872203B1 (en) | Methods of administering solriamfetol to lactating women | |
| US20210267944A1 (en) | Methods for treating agitation using dexmedetomidine hydrochloride | |
| RU2616520C2 (ru) | Лечение симптомов, связанных с гастропарезом у женщин | |
| US12005036B1 (en) | Methods of administering solriamfetol to lactating women | |
| US20240216302A1 (en) | Methods of administering solriamfetol to lactating women | |
| US20240216301A1 (en) | Methods of administering solriamfetol to lactating women | |
| US20240216303A1 (en) | Methods of administering solriamfetol to lactating women | |
| US20240216300A1 (en) | Methods of administering solriamfetol to lactating women | |
| WO2024145545A2 (fr) | Procédés d'administration de solriamfétol à des femmes en lactation | |
| US20220133717A1 (en) | Rabeximod in the treatment of rheumatoid arthritis | |
| US20190388370A1 (en) | Treatment of symptoms associated with female gastroparesis | |
| Adler et al. | Intervention Helps Workers With Depression. | |
| KR20220027981A (ko) | 수면 문제를 치료하기 위한 렘보렉산트 | |
| Tablets | CONCERTA® | |
| Babayan et al. | Neuroleptics and antipsychotic drugs |