HU229908B1 - Darifenacin hiperaktív hólyag által kiváltott sürgõsség kezelésében való alkalmazásra - Google Patents
Darifenacin hiperaktív hólyag által kiváltott sürgõsség kezelésében való alkalmazásra Download PDFInfo
- Publication number
- HU229908B1 HU229908B1 HU0402625A HUP0402625A HU229908B1 HU 229908 B1 HU229908 B1 HU 229908B1 HU 0402625 A HU0402625 A HU 0402625A HU P0402625 A HUP0402625 A HU P0402625A HU 229908 B1 HU229908 B1 HU 229908B1
- Authority
- HU
- Hungary
- Prior art keywords
- patients
- urgency
- treatment
- darifenacin
- time
- Prior art date
Links
- HXGBXQDTNZMWGS-RUZDIDTESA-N darifenacin Chemical compound C=1C=CC=CC=1C([C@H]1CN(CCC=2C=C3CCOC3=CC=2)CC1)(C(=O)N)C1=CC=CC=C1 HXGBXQDTNZMWGS-RUZDIDTESA-N 0.000 title claims description 12
- 206010020853 Hypertonic bladder Diseases 0.000 title claims description 10
- 229960002677 darifenacin Drugs 0.000 title claims description 10
- 208000009722 Overactive Urinary Bladder Diseases 0.000 title description 2
- 208000020629 overactive bladder Diseases 0.000 title description 2
- 208000024891 symptom Diseases 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 5
- 150000003839 salts Chemical group 0.000 claims description 5
- 239000003814 drug Substances 0.000 claims description 4
- 239000000902 placebo Substances 0.000 claims description 4
- 229940068196 placebo Drugs 0.000 claims description 4
- CPELXLSAUQHCOX-UHFFFAOYSA-N Hydrogen bromide Chemical compound Br CPELXLSAUQHCOX-UHFFFAOYSA-N 0.000 claims description 3
- 210000003750 lower gastrointestinal tract Anatomy 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 239000013563 matrix tablet Substances 0.000 claims description 2
- 206010012735 Diarrhoea Diseases 0.000 claims 1
- 240000004808 Saccharomyces cerevisiae Species 0.000 claims 1
- 238000005266 casting Methods 0.000 claims 1
- 239000000551 dentifrice Substances 0.000 claims 1
- 238000012377 drug delivery Methods 0.000 claims 1
- 230000002035 prolonged effect Effects 0.000 claims 1
- 206010021639 Incontinence Diseases 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 101100440640 Drosophila melanogaster conu gene Proteins 0.000 description 1
- 241000258180 Echinacea <Echinodermata> Species 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 208000007502 anemia Diseases 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 235000014134 echinacea Nutrition 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- ZYCMDWDFIQDPLP-UHFFFAOYSA-N hbr bromine Chemical compound Br.Br ZYCMDWDFIQDPLP-UHFFFAOYSA-N 0.000 description 1
- 230000009610 hypersensitivity Effects 0.000 description 1
- 238000009533 lab test Methods 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 239000012453 solvate Substances 0.000 description 1
- 239000006228 supernatant Substances 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4025—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil not condensed and containing further heterocyclic rings, e.g. cromakalim
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/402—1-aryl substituted, e.g. piretanide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/12—Antidiuretics, e.g. drugs for diabetes insipidus
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Urology & Nephrology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Medicinal Preparation (AREA)
- Plural Heterocyclic Compounds (AREA)
- Chemical Treatment Of Metals (AREA)
- Diaphragms For Electromechanical Transducers (AREA)
- Processing Of Meat And Fish (AREA)
- Document Processing Apparatus (AREA)
- Pyridine Compounds (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Inorganic Insulating Materials (AREA)
- Crystals, And After-Treatments Of Crystals (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
Description
A sürgősségi események száma/nap | Placebo | 7,5 mg | 15 mg | 30 mg: |
Alapvonal | 83 | 8,5 | 8,6 | 8,4 |
Közepes eltérés az alapvonaltól | -1,2 | -1,8 | . O -3* X-.J A ....... | |
Közepes %-os eltérés az alapvonaltól | -15/7 | -29/2 | 26,9 | -33,1 |
A. sürgősségi, események súlyossága/nap | Placebo | 7,5 mg | 15 mg | 30 mg |
: Alapvonal. | 53,5 | 53,2 | 58,2 | 53,5 |
Közepes eltérés az alapvonaltól | -3,9 | ..... .·····? : : - z | l|/-7Í3://: | -9,4* |
Közepes %-os eltérés az alapvonaltól | -8,0 | -14,2 | -1.1,6 | -19,9 |
A sürgősségi események száma/nap | 7,5 mg | 15 mg | 30 mg |
Alapvonal | 8,5 | 8,6 | 83 |
Közepes eltérés a piacehétől | -0,5 | -fel* | 3,4*** |
A sürgősség súlyossága/nap | feo mg | 15 mg | 30 mg |
Alapvonal | 53,2 | 56,2 | 53,5 |
Közepes eltérés a piaeebőtöl | -2,5 | -3,8* | -5,5* |
Claims (1)
- 2, klinikai vizsgálatEz a. vizsgáját egy űj módszert alkalmazott a sürgősség első fellépése és a vlzelés szükségessége közötti idő mérésére, amelyet mgyelmeztetési időfenek; neveznek:. Egy módosított stopperórát, használtak, amelynek, az egyik gombját akkor kellett megnyomnia a betegeknek, amikor a sürgősség fellepett, és egy második gombját akkor, amikor ügy érezték, hogy vizelniük kellDarifenaoint (hidrobromidsö formájában; 30 mg o.d.) és plánéból, értékeltünk, sürgősségi tünetes egyebekben. Az «gyedek között ndves ;VV3 g\o\a\v vV;\, ' 'oooo.x 'V ' \3 a,\ V lap ' κ o7® bőt/73 tési idöM az alapvonalon és a kéthetes kezelést követően értékeltük a módosított stopperóra alkalmazásával.beteg (29 nő, 7 férfi) kapott darkenaeint; éo 36 beteg (22 nő, 14 férfi) kapott pktcehóLA sürgősségtől szenvedő, dariíenaemnal kezelt egyebeknél jelentősen meghosszabbodott a figyelmeztetési idő a piacé hóval kezelt egyediekhez viszonyítva. Az adatok a 3. táblázatban láthatok.Meg kell jegyeznünk, hogy mind a nedves O.AB, mind a száraz OAB betegek rt:ágálták a kezelésre.
Sürgősségi idő (pere) Dariíénaein P.1 a.cebo- .Alapvon al (középérték) 4,7 ((((((((((((Ül)))))))))))/)! Két hét eltelte után (középérték) 8,4:V ................................... ...................... ..................................................................... 4/1 * ®0mI\ ** P® Ml '“FW01A közepes eltérés a placebőtól 4,3 pere.KövetkeztetésekAz eredmények azt mutatják, hogy a dariíénaein a, hiperaküv hólyagtól szenvedő egyesekben a sürgősség tünetet klinikadag szignifikáns módon envbitette.700053/PAI. Danfenada vagy gyögyássaiilag elfogadható saármas^kának alkalmasába hiperaktív hólyagtól szenvedő betegekben a sürgősség csökkentésére alkalmas gyógyszer előállításában,X Ás 1. igénypont szerinti alkalmazás, ahol adarifenadn gyógy aaaatílag elfogadható só formában van,3. Ás 1. vagy 2, Igénypont szerinti alkalmasás, ahol a darifenaeínt vagy gyógyta&tüag elfogadható sssánnasékát olyan dőrisformában adagoljuk, amefyfeől a datifenaeinnak vagy gyógyászatilag elfogadható ssármasékanak legalább 10 %-a a befog alsó gyomor-bél traktusában asabadnl fel,4, Á 3, igénypont szerinti alkalmasás, ahol a dosisfornxa egy lassú hatőanyagdeadásn mátrix tabletta..Á meghatalmazott , -nOAgfoüÁÁ ASys\' xWU SS } te-s é teteted \%v ·: ;te.te < \ U tete
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0129962.7A GB0129962D0 (en) | 2001-12-14 | 2001-12-14 | Method of treatment |
PCT/IB2002/000664 WO2003051354A1 (en) | 2001-12-14 | 2002-03-05 | Method of treatment |
Publications (2)
Publication Number | Publication Date |
---|---|
HUP0402625A2 HUP0402625A2 (hu) | 2005-04-28 |
HU229908B1 true HU229908B1 (hu) | 2014-12-29 |
Family
ID=9927643
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HU0402625A HU229908B1 (hu) | 2001-12-14 | 2002-03-05 | Darifenacin hiperaktív hólyag által kiváltott sürgõsség kezelésében való alkalmazásra |
Country Status (28)
Country | Link |
---|---|
US (3) | US20030130338A1 (hu) |
EP (1) | EP1458376B1 (hu) |
JP (3) | JP2005516925A (hu) |
KR (1) | KR100889086B1 (hu) |
CN (1) | CN100488505C (hu) |
AT (1) | ATE341323T1 (hu) |
AU (1) | AU2002236141B2 (hu) |
BR (1) | BR0214925A (hu) |
CA (1) | CA2469702C (hu) |
CY (1) | CY1105814T1 (hu) |
CZ (1) | CZ301283B6 (hu) |
DE (1) | DE60215219T2 (hu) |
DK (1) | DK1458376T3 (hu) |
ES (1) | ES2276910T3 (hu) |
GB (1) | GB0129962D0 (hu) |
HK (1) | HK1073779A1 (hu) |
HU (1) | HU229908B1 (hu) |
IL (2) | IL162391A0 (hu) |
MX (1) | MXPA04005760A (hu) |
NO (1) | NO20042586L (hu) |
NZ (1) | NZ533421A (hu) |
PL (1) | PL206034B1 (hu) |
PT (1) | PT1458376E (hu) |
RU (1) | RU2321398C2 (hu) |
SI (1) | SI1458376T1 (hu) |
SK (1) | SK287510B6 (hu) |
WO (1) | WO2003051354A1 (hu) |
ZA (1) | ZA200404289B (hu) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090062326A1 (en) * | 2006-03-17 | 2009-03-05 | Spindel Eliot R | M3 muscarinic receptor antagonists for treatment of m3 muscarinic receptor-expressing tumors |
CN101084891A (zh) * | 2007-06-29 | 2007-12-12 | 北京本草天源药物研究院 | 一种用于口服的达非那新或其药用盐的药物制剂 |
CZ200845A3 (cs) * | 2008-01-28 | 2009-09-02 | Zentiva, A. S. | Zpusob prípravy Darifenacinu |
NZ594311A (en) * | 2009-02-04 | 2013-05-31 | Astellas Pharma Inc | Pharmaceutical composition comprising tamsulosin and solifenacin for oral administration |
CN102048706B (zh) * | 2011-01-12 | 2012-02-22 | 山东创新药物研发有限公司 | 一种氢溴酸达非那新缓释片及制备方法 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB8906166D0 (en) * | 1989-03-17 | 1989-05-04 | Pfizer Ltd | Therapeutic agents |
GB9518953D0 (en) * | 1995-09-15 | 1995-11-15 | Pfizer Ltd | Pharmaceutical formulations |
-
2001
- 2001-12-14 GB GBGB0129962.7A patent/GB0129962D0/en not_active Ceased
-
2002
- 2002-03-05 KR KR1020047009000A patent/KR100889086B1/ko active IP Right Grant
- 2002-03-05 WO PCT/IB2002/000664 patent/WO2003051354A1/en active IP Right Grant
- 2002-03-05 DE DE60215219T patent/DE60215219T2/de not_active Expired - Lifetime
- 2002-03-05 CA CA2469702A patent/CA2469702C/en not_active Expired - Lifetime
- 2002-03-05 PL PL369426A patent/PL206034B1/pl unknown
- 2002-03-05 AU AU2002236141A patent/AU2002236141B2/en not_active Expired
- 2002-03-05 SK SK250-2004A patent/SK287510B6/sk not_active IP Right Cessation
- 2002-03-05 SI SI200230464T patent/SI1458376T1/sl unknown
- 2002-03-05 HU HU0402625A patent/HU229908B1/hu not_active IP Right Cessation
- 2002-03-05 IL IL16239102A patent/IL162391A0/xx unknown
- 2002-03-05 PT PT02702623T patent/PT1458376E/pt unknown
- 2002-03-05 MX MXPA04005760A patent/MXPA04005760A/es active IP Right Grant
- 2002-03-05 EP EP02702623A patent/EP1458376B1/en not_active Expired - Lifetime
- 2002-03-05 DK DK02702623T patent/DK1458376T3/da active
- 2002-03-05 RU RU2004121780/15A patent/RU2321398C2/ru active
- 2002-03-05 NZ NZ533421A patent/NZ533421A/en not_active IP Right Cessation
- 2002-03-05 BR BR0214925-7A patent/BR0214925A/pt active Search and Examination
- 2002-03-05 ES ES02702623T patent/ES2276910T3/es not_active Expired - Lifetime
- 2002-03-05 JP JP2003552287A patent/JP2005516925A/ja not_active Withdrawn
- 2002-03-05 AT AT02702623T patent/ATE341323T1/de active
- 2002-03-05 CN CNB028249364A patent/CN100488505C/zh not_active Expired - Lifetime
- 2002-03-05 CZ CZ20040719A patent/CZ301283B6/cs not_active IP Right Cessation
- 2002-09-26 US US10/256,420 patent/US20030130338A1/en not_active Abandoned
-
2004
- 2004-06-01 ZA ZA2004/04289A patent/ZA200404289B/en unknown
- 2004-06-07 IL IL162391A patent/IL162391A/en active IP Right Grant
- 2004-06-18 NO NO20042586A patent/NO20042586L/no not_active Application Discontinuation
-
2005
- 2005-07-25 HK HK05106309.8A patent/HK1073779A1/xx not_active IP Right Cessation
-
2006
- 2006-11-30 CY CY20061101729T patent/CY1105814T1/el unknown
-
2007
- 2007-07-19 US US11/880,006 patent/US20070264333A1/en not_active Abandoned
-
2009
- 2009-03-04 US US12/397,433 patent/US8748476B2/en not_active Expired - Lifetime
- 2009-10-30 JP JP2009250519A patent/JP2010024244A/ja not_active Withdrawn
-
2013
- 2013-07-11 JP JP2013145736A patent/JP2013199506A/ja active Pending
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GB9A | Succession in title |
Owner name: MERUS LABS LUXCO SARL, LU Free format text: FORMER OWNER(S): NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD., BM |
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FH91 | Appointment of a representative |
Free format text: FORMER REPRESENTATIVE(S): S.B.G. & K. SZABADALMI UEGYVIVOEI IRODA, HU Representative=s name: SBGK SZABADALMI ES UEGYVEDI IRODA, HU |
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FH92 | Termination of representative |
Representative=s name: S.B.G. & K. SZABADALMI UEGYVIVOEI IRODA, HU |
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GB9A | Succession in title |
Owner name: MERUS LABS LUXCO II S.A.R.L., LU Free format text: FORMER OWNER(S): NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD., BM; MERUS LABS LUXCO SARL, LU |
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MM4A | Lapse of definitive patent protection due to non-payment of fees |