|
●薬剤分類情報閲覧システム（厚労省診療情報提供サービス）」 - １２２ 骨格筋弛緩剤 /2008.2.16現在
--- http://www1.iryohoken.ne.jp/yakuzai/index.html ; 先発医薬品と後発医薬品の一覧表 2002.4.1-
| [1276]●製品 シクロベンザプリン徐放性製剤 cyclobenzaprine HCl extended-release capsules（Amrix- Cephalon） |
日本語版註シクロベンザプリン徐放性製剤 cyclobenzaprine HCl extended-release capsules（Amrix- Cephalon）
【別名】 【開発元】ECR Pharmaceuticals [DBR_ID]
【化学名】3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride
【承認】FDA申請=April 29, 2004、FDA承認=Feb 1,2007(製造販売ECR Pharmaceuticals, Inc)販売Cephalon社子会社Anesta社; 【製剤】extended-release capsules - 15 and 30 mg cyclobenzaprine hydrochloride 【適応】(急性筋肉痛に伴う筋肉痙攣) indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. 【用法用量】通常成人１日１回15mg。 １日１回30mg迄可。 但し２～３週間を超えないこと。 【作用】a skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. 【特徴】１日１回 【製品情報】www.amrix.com 【添付文書】AMRIX Prescribing Information 【提携】2007.8.23 Cephalon社は北米ライセンス獲得。、米国は子会社Anesta社が販売 【EU】未開発 【日本】未開発 【その他】AMRIXはECR Pharmaceuticals, Incの商標。 Amrix(R) is an extended release muscle relaxant product developed by Eurand for ECR using its proprietary Diffucaps(R) technology.
日本語版註）シクロベンザプリンcyclobenzaprine HCl (FLEXERIL [MCNEIL PED])
【別名】MK-130 【開発元】Merck & Co [DBR_ID]02446-1220
【化学名】3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride
【承認】FDA申請=、FDA承認=Aug 26,1977 ; 【製剤】Tablets contain 5mg,10mg Cyclobenzaprine HCl 【適応】indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. 【用法用量】初回15才以上１日5mgを３回、通常１日10mgを３回。 但し２～３週間を超えないこと。 【作用】Cyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle function. 中枢神経系筋肉痙攣には無効。 【特徴】 【製品情報】http://www.flexeril5mg.com/ 【添付文書】FLEXERIL-PI 【EU】 【日本】未開発 【その他】Flexerilは米Merck社が創製し米国では1977から販売されているが、Alza社がMerckから2001年にFlexerilの権利を商標を含めて買収。 その後Alza社をJ&Jが買収し、現在米国ではMcNeil-PPC, Incの事業部のMcNeil Pediatricsが販売。
●CYCLOBENZAPRINE HCL[INN][NFN][USAN] 02446-1220 by MERCK SHARP & DOHME[US] in 1959
CYCLOBENZAPRINE HCL;CYCLOBENZAPRINE HCL[INN][NFN][USAN];FLEXERIL;FLEXIBAN;KCB-691;LISSERIL;MK-130;PROHEPTATRIENE;RO 4-1577;RP-9715;塩酸シクロベンザプリン;シクロベンザプリン;シクロベンザプリン塩酸塩;フレキシリール
《JA》KCB-691（キッセイ薬品工業㈱）IN IU＊∥《US》FLEXERIL（MERCK SHARP & DOHME）10-77＊∥CYCLOBENZAPRINE HCL（BARR LABORATORIES, INC.）05-95＊NDA MAY95∥《IT》FLEXIBAN（MERCK SHARP & DOHME）-85＊
【日本語版コメント】
筋弛緩剤は２つに分類され、まず筋緊張状態の改善(腰痛・肩こり等)を主適応とする中枢性筋弛緩剤があり、塩酸エペリゾン(ミオナール他)と塩酸チザニジン(テルネリン他)の両者で年間200億円市場のシェア85%を占める。 意識を伴わずに中枢神経系（脊髄の介在ニューロンや脳幹の介在ニューロン）の抑制で骨格筋の弛緩を起こすのが中枢性筋弛緩剤である。臨床では、脳性・脊髄性の筋痙攣や硬直・痙性麻痺・腰痛・筋緊張性頭痛などが適応となる。
もう一つの末梢性筋弛緩剤は、「麻酔時や気管挿管時の筋弛緩」に使われ、臭化ベクロニウム(マスキュラックス静注用)が最も繁用(市場規模70億円中トップシェア43%の30億円)されてきたが、昨2007年10月から後継品で替わってトップ製品と見込まれる臭化ロクロニウム(スラックス(R)静注[日本オルガノン])が登場した。といっても1994年に米国、英国等で承認、現在世界88ヵ国で承認されているので、日本導入が大幅に遅れたわけだが。
→詳細は参考資料●MLリソース：筋弛緩剤に纏めた。
<日本語版コメント要約＞
・中枢に作用する筋弛緩薬シクロベンザプリンの徐放性製剤が、筋痙攣の治療薬としてFDAに承認された。
・本剤は、中枢の下行性セロトニン作動性経路に作用し、緊張性の体性運動活性を抑制すると考えられる。
・徐放性製剤は利便性が高いが、速放性製剤との有効性比較データはない。
●2004.5.1 以降 Drugs@FDA
Drug Name(s) =AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE)
FDA Application No. =(NDA) 021777
Active Ingredient(s)=CYCLOBENZAPRINE HYDROCHLORIDE
Company =ANESTA
Dosage Form/Route =CAPSULE, EXTENDED RELEASE; ORAL
Strength =15MG,30mg
- Approval Date=02/01/2007[000][Approval] :Label[添付文書]|Letter[承認書]|
To ECR Pharmaceuticals
Drug Name(s) =FLEXERIL (CYCLOBENZAPRINE HYDROCHLORIDE)
FDA Application No. =(NDA) 017821
Active Ingredient(s)=CYCLOBENZAPRINE HYDROCHLORIDE
Company =MCNEIL PED
Dosage Form/Route =TABLET; ORAL
Strength =5MG,10MG
- Approval Date=08/26/1977[000][Approval] :
- Approval Date=02/03/2003[045][Efficacy Supplement with Clinical Data to Support] :Label[添付文書]|Letter[承認書]|
Manufactured by Merck & Co. Inc., West Point, PA 19486, USA.
Distributed and Marketed by McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA 19034
Original Approval or Tentative Approval Date August 26, 1977
Chemical Type 1 New molecular entity (NME)
Review Classification P Priority review drug
/2008.1.18
Appl
No | TE Code | RLD | Active
Ingredient | Dosage Form;
Route | Strength | Proprietary
Name | Applicant | 承認日 |
|---|
| 021777 | | No | CYCLOBENZAPRINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE; ORAL | 15MG,30MG | AMRIX | ANESTA | Feb 1, 2007 |
| 077209 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 10MG | CYCLOBENZAPRINE HYDROCHLORIDE | ACTAVIS TOTOWA | Oct 4, 2005 |
| 077291 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 5MG | CYCLOBENZAPRINE HYDROCHLORIDE | ACTAVIS TOTOWA | Feb 3, 2006 |
| 077563 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 5MG,10MG | CYCLOBENZAPRINE HYDROCHLORIDE | CADISTA PHARMS | Apr 19, 2006 |
| 017821 | AB | Yes | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 5MG,10MG | FLEXERIL | MCNEIL PED | Aug 26,1977 |
| 073541 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 5MG,10MG | CYCLOBENZAPRINE HYDROCHLORIDE | MUTUAL PHARM | [10mg]May 23, 1995
[5mg]Apr 6, 2006 |
| 073144 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 5MG,10MG | CYCLOBENZAPRINE HYDROCHLORIDE | MYLAN | [10mg]May 30, 1991
[5mg]Feb 3, 2006 |
| 074421 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 10MG | CYCLOBENZAPRINE HYDROCHLORIDE | PLIVA | Sep 29, 1995 |
| 072854 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 10MG | CYCLOBENZAPRINE HYDROCHLORIDE | SANDOZ | [10mg]Nov 19, 1991
[5mg]Feb 3, 2006 |
| 073683 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 10MG | CYCLOBENZAPRINE HYDROCHLORIDE | SANDOZ | Feb 26, 1993 |
| 072854 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 5MG | CYCLOBENZAPRINE HYDROCHLORIDE | SANDOZ | [10mg]Nov 19, 1991
[5mg]Feb 3, 2006 |
| 077797 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 5MG,10MG | CYCLOBENZAPRINE HYDROCHLORIDE | VINTAGE PHARMS | Feb 28, 2007 |
| 073143 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 10MG | CYCLOBENZAPRINE HYDROCHLORIDE | WATSON LABS | Nov 27, 1991 |
| 071611 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 5MG,7.5MG,10MG | CYCLOBENZAPRINE HYDROCHLORIDE | WATSON LABS | [10mg]May 3, 1989
[5mg,7.5mg]Feb 3, 2006 |
| 074436 | AB | No | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET; ORAL | 10MG | CYCLOBENZAPRINE HYDROCHLORIDE | WATSON LABS | Nov 30, 1994 |
Application Number: 021777
Active Ingredient : CYCLOBENZAPRINE HYDROCHLORIDE
Proprietary Name : AMRIX [ANESTA] CAPSULE, EXTENDED RELEASE; ORAL 15MG,30MG
Approval Date : Feb 1, 2007
Exclusivity Data : NDF FEB 01,2010
Patent Data : -
Application Number: 017821
Active Ingredient : CYCLOBENZAPRINE HYDROCHLORIDE
Proprietary Name : FLEXERIL [MCNEIL PED] TABLET; ORAL 5MG,10MG
Approval Date : Aug 26,1977
Exclusivity Data : -
Patent Data : -
AH Robins Companyは、1989年American Home Products (現Wyeth)に売却されたが、その後
創業者Robins一族のE. Claiborne Robins, JrがECR Pharmaceuticalsを設立。
現在一般薬メーカーとしてBranded Pharmaceutical Association会員
Virginia Biotechnology Association(VaBIO)会員。
●Products & Dosage
●Newsline
ECR Sells Amrix to Cephalon[2007.11]
- ECR recently announced that Cephalon, a major US pharmaceutical and biotech firm, had acquired the
Company's marketing rights to Amrix, a once-a-day dosage muscle relaxant formulation. Amrix is the fir
st in its class of once daily musculoskeletal relaxants. Its active ingredient is cyclobenzaprine, the
most widely prescribed drug in this market.
FDA Approves ECR's New Drug Application[2007.3]
- ECR Pharmaceuticals has received approval for its new drug application for AMRIX(R) (cyclobenzaprine
hydrochloride extended release capsules). The product is a once-a-day dosage formulation and is indica
ted as an adjunct for the treatment of skeletal muscle spasm, notably that which is associated with bac
k pain and similar musculoskeletal disorders. The product will be available only by prescription and th
e firm anticipates marketing the product by late summer 2007
- http://www.cephalon.com/
バイオ企業、1987年設立；従業員数2200人。
本社米国West Chester, Pennsylvania
米国で３新薬を含む世界で２０製品を販売
2000.10.10 Anesta Corp.[米]を買収、100%子会社とする。同社名のまま存続。
(ACTIQ(R) (oral transmucosal fentanyl citrate)を手に入れた )
2001.12.28 Group Lafon(Laboratoire L Lafonが中核)[仏]の買収完了。
(Provigilの開発元)(買収額$454.2 million)。同社名のまま存続。
●Products
AMRIX(Cyclobenzaprine HCl Extended-release capsules) - 骨格筋弛緩剤
PROVIGIL(midafinil) - 睡眠障害治療薬
FENTORA(fentanyl buccal tablets) -鎮痛剤(子会社CIMA Labs開発のOraVescent(R) drug delivery system利用)
VIVITROL(naltrexone extended-release injectable suspension) - 最初で唯一の月１回投与のアルコール依存症治療薬
- Alkermes, Inc.から2005.6に米国ライセンス
Trisenox(arsenic trioxide) -骨髄性白血病
- Cell Therapeutics, Inc.から2005.7譲受($71.9 million)
ACTIQ(oral transmucosal fentanyl citrate) - 癌疼痛用薬
GABITRIL(tiagabine HCl) -抗てんかん剤
●Investor Information
★SEC Filing
- FORM 10-K(2007.2.28) - [pdf]
- FORM 10-K(2006.3.13) - [pdf,]
- FORM 10-K(2005.3.15)
- FORM 10-K(2004.3.)
★Annual Reports
●News Room
Cephalon Reports Outstanding Financial Results for 2005[2006.2.14]
Cephalon, Inc. Completes Acquisition of TRISENOX(R) From Cell Therapeutics, Inc.[2005.7.19]
Cephalon, Inc. Reports Record Financial Results for 2003[2004.2.12]
Cephalon Reports Outstanding Financial Results for 2004[2005.2.15]
●Research and Development
Pipeline
08/23/07★Cephalon, Inc. Announces Agreement to Acquire AMRIX, A Once-Daily Extended-Release Muscle Relaxant
[]dantrolene sodium (Dantrium [P&G])
| []●製品 dantrolene sodium (Dantrium [P&G]) |
日本語版註）dantrolene sodium (Dantrium [P&G])
【別名】F-368[AS BASE];F-440; 【開発元】Norwich Eaton Pharmaceuticals,→現Procter &Gamble子会社 [DBR_ID]02107-1220
【化学名】hydrated 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2, 4-imidazolidinedione sodium salt
【承認】FDA申請=、FDA承認=15 Jan 1975; 【製剤】Capsules - 25 mg, 50 mg, and 100 mg of dantrolene sodium; Dantrium Intravenous is supplied in 70 mL vials containing 20 mg dantrolene sodium 【適応～静注】1)Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages 2)Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible. 【適応～カプセル】1)In Chronic Spasticity: Dantrium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). 2)In Malignant Hyperthermia: Oral Dantrium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. 【用法用量】[Chronic Spasticity]成人初回25mg１日１回７日間、２週目25mg tid,３週目50mg tid,最大100mg tid→添付文書 【作用】 【特徴】 【添付文書】Dantrium Capsules Full Prescribing Product Information & Dantrium I.V. Full Prescribing Product Information 【EU】 【日本】ダントリウム静注用20mg & ダントリウムカプセル25mg,50mg[製造販売／アステラス製薬株式会社 提携／プロクター・アンド・ギャンブル・ファーマシューティカルズ]Dantrium発売1981年１月(Cap)発売1985年9月(注)効能追加承認年月1994年7月 【製剤～日本】1バイアル中日局ダントロレンナトリウム水和物20mg；１カプセル中日局ダントロレンナトリウム水和物25mg,50mg 【適応～日本】1)麻酔時における悪性高熱症(注) 2)悪性症候群(注,Cap) 3)全身こむら返り病(Cap) 4)下記疾患に伴う痙性麻痺(Cap)：脳血管障害後遺症、脳性麻痺、外傷後遺症（頭部外傷、脊髄損傷）、頸部脊椎症、後縦靱帯骨化症、脊髄小脳変性症、痙性脊髄麻痺、脊髄炎、脊髄症、筋萎縮性側索硬化症、多発性硬化症、スモン（SMON）、潜水病 【用法用量～日本】1)麻酔時における悪性高熱症(初回量1mg/kgを静脈内投与し、1mg/kgずつ追加、最大7mg/kg) 2)悪性症候群(初回量40mgを静脈内投与し、20mgずつ増量、最大200mg) 3)全身こむら返り病および痙性麻痺(成人１日１回25mgより投与を始め、１週毎に25mgずつ増量し（１日２～３回に分割投与）維持量を決定する。ただし、１日最高投与量は150mg３回分割投与。) 【添付文書～日本】ダントリウムカプセル25mg・カプセル50mg ダントリウム静注用20mg 【その他】国際誕生1974年1月
●02107-1220 by NORWICH-EATON PHARM.[US] 1966
DANTAMACRIN;DANTRIUM;DANTRIUM[;ｱｸｾｲｼﾖｳｺｳｸﾞﾝ];DANTRIUM FOR INJ ﾀﾞﾝﾄﾘｳﾑ;DANTRIUM ﾀﾞﾝﾄﾘｳﾑ;DANTRIX;DANTROLENE NA;DANTROLENE SODIUM[INN][USAN][BAN][NFN];DANTROLEN I.V.;F-368[AS BASE];F-440;ﾀﾞﾝﾄﾘｳﾑ;ﾀﾞﾝﾄﾛﾚﾝｿｼﾞｳﾑ;ﾀﾞﾝﾄﾛﾚﾝﾅﾄﾘｳﾑ
《JA》DANTRIUM ﾀﾞﾝﾄﾘｳﾑ（山之内製薬㈱）01-81＊∥DANTRIUM FOR INJ ﾀﾞﾝﾄﾘｳﾑ（山之内製薬㈱）09-85＊∥DANTRIUM[;ｱｸｾｲｼﾖｳｺｳｸﾞﾝ]（山之内製薬㈱）07-94＊93/12∥《US》DANTRIUM（NORWICH-EATON PHARM.）02-74＊∥《UK》DANTRIUM（NORWICH-EATON PHARM.）03-75＊∥《FR》DANTRIUM（OBERVAL,LABS）06-79＊∥《WG》DANTRIUM（ROHM PHARMA GMBH）01-81＊∥DANTAMACRIN（ROHM PHARMA GMBH）12-77＊∥DANTROLEN I.V.（ROHM PHARMA GMBH）05-81＊∥《IT》DANTRIUM（FORMENTI DOTT SPA）-81＊∥DANTRIX（SIT SPA [SPEC IGIEN TERA）01-83＊NA TETRAHYDR
●2004.5.1 以降 Drugs@FDA
Drug Name(s) =DANTRIUM (DANTROLENE SODIUM)
FDA Application No. =NDA # 017443
Active Ingredient(s)=DANTROLENE SODIUM
Company =PROCTER AND GAMBLE
Dosage Form/Route =CAPSULE; ORAL: 100MG; 25MG; 50MG
Strength =
- Approval Date=01/15/1974[000] :
Original Approval or Tentative Approval Date January 15, 1974
Chemical Type 1 New molecular entity (NME)
Review Classification P Priority review drug
FDA Application No. =NDA # 018264
Active Ingredient(s)=DANTROLENE SODIUM
Company =PROCTER AND GAMBLE
Dosage Form/Route =INJECTABLE; INJECTION: 20MG/VIAL
Strength =
- Approval Date=09/19/1979[000] :
Original Approval or Tentative Approval Date September 19, 1979
Chemical Type 3 New dosage form
Review Classification P Priority review drug /O Orphan drug
Drug Name(s) =DANTROLENE SODIUM (DANTROLENE SODIUM)
FDA Application No. =ANDA # 076686
Active Ingredient(s)=DANTROLENE SODIUM
Company =ACTAVIS TOTOWA
Dosage Form/Route =CAPSULE; ORAL: 100MG; 25MG; 50MG
Strength =
- Approval Date=10/24/2005[000] :
Original Approval or Tentative Approval Date October 24, 2005
FDA Application No. =ANDA # 076856
Active Ingredient(s)=DANTROLENE SODIUM
Company =IMPAX LABS
Dosage Form/Route =CAPSULE; ORAL: 100MG; 25MG; 50MG
Strength =
- Approval Date=03/01/2005[000] :
Original Approval or Tentative Approval Date March 1, 2005
FDA Application No. =ANDA # 078378
Active Ingredient(s)=DANTROLENE SODIUM
Company =US WORLDMEDS
Dosage Form/Route =INJECTABLE; INJECTION: 20MG/VIAL
Strength =
- Approval Date=07/24/2007[000] :Letter[承認書]|<
Original Approval or Tentative Approval Date July 24, 2007
Application Number: 017443
Active Ingredient : DANTROLENE SODIUM
Proprietary Name : DANTRIUM [PROCTER AND GAMBLE] CAPSULE; ORAL 25MG,50MG,100MG
Approval Date : Approved Prior to Jan 1, 1982
Exclusivity Data : -
Patent Data : -
Application Number: 018264
Active Ingredient : DANTROLENE SODIUM
Proprietary Name : DANTRIUM [PROCTER AND GAMBLE] INJECTABLE; INJECTION 20MG/VIAL
Approval Date : Approved Prior to Jan 1, 1982
Exclusivity Data : -
Patent Data : -
Application Number: 076686
Active Ingredient : DANTROLENE SODIUM
Proprietary Name : DANTROLENE SODIUM [ACTAVIS TOTOWA] CAPSULE; ORAL 25MG,50MG,100MG
Approval Date : Oct 24, 2005
Exclusivity Data : -
Patent Data : -
Application Number: 076856
Active Ingredient : DANTROLENE SODIUM
Proprietary Name : DANTROLENE SODIUM [IMPAX LABS ] CAPSULE; ORAL 25MG,50MG,100MG
Approval Date : Mar 1, 2005
Exclusivity Data : -
Patent Data : -
Application Number: 078378
Active Ingredient : DANTROLENE SODIUM
Proprietary Name : DANTROLENE SODIUM [US WORLDMEDS ] INJECTABLE; INJECTION 20MG/VIAL
Approval Date : Jul 24, 2007
Exclusivity Data : -
Patent Data : -
●EMEA - Human Medcines
●List of Authorized Products (EPARs)★[A-Z 承認品目]
該当なし
■Investors
●Annual Reports
●SEC Filing
Annual Filings 10-K[08/28/07] - [pdf]- [word]
●News
●P&G日本支社
- http://jp.pg.com/ ; 日本支社では医薬品は扱わない
ニュースリリース～医薬品は除かれている
決算情報
- http://www.pgpharma.com/index.shtml
●P&GP Products
Actonel ®(risedronate sodium tablets) - osteoporosis
Asacol ® (mesalamine)Delayed-Release Tablets -ulcerative colitis
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[]tizanidine HCl(Zanaflex[Acorda]) 塩酸チザニジン(テルネリン[ノバルティス])
| []●製品 tizanidine HCl(Zanaflex[Acorda]) 塩酸チザニジン(テルネリン[ノバルティス]) |
日本語版註）tizanidine HCl(Zanaflex[Acorda]) 塩酸チザニジン(テルネリン[ノバルティス])
【別名】DS 103-282;SIRDALUD;ZANAFLEX 【開発元】Sandoz AG →現Novartis [DBR_ID]18209-1220
【化学名】5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole HCl
【承認】FDA申請=、FDA承認=27 Nov 1996 ; 【製剤】Tablets - 2mg,4mg;Capsules -2mg,4mg and 6mg tizanidine HCl 【適応】for the management of spasticity 【用法用量】１回8mg。 １日３回迄、最大１日36mg迄。 【作用】塩酸チザニジンは種々の動物実験により、脊髄及び脊髄上位の中枢に作用し固縮緩解作用、脊髄反射抑制作用等の筋緊張緩和作用を有することが確認されている。臨床的には疼痛を伴う筋緊張及び脳性・脊髄性疾患に起因する慢性痙縮に対して筋のこわばり、つっぱり感、こり感、痛み等の症状を改善し日常生活動作を容易にする。 【特徴】 【製品情報】www.zanaflex.com 【添付文書】Zanaflex full prescribing information 【EU】商品名：Sirdalud(R)[Novartisまたは関連会社] 発売国：スイス、オランダ、ドイツ、デンマーク、ベルギー、ギリシャ、ルクセンブルグ、ポルトガル、イタリア、ウルグアイ、フィンランド、ブラジル、オーストリア、スペイン、アルゼンチン、韓国、チリ、コロンビア、タイ ほか; 1991年米Athena Neurosciences, Inc.は米・加・英・アイルランドの独占販売権をSandoz Pharma Ltd.から取得、thenaは1993.12にNDA申請、1996.3 approval letter受領。Athenaは1996.6.27にElanに吸収合併。ElanがZanaflex(tizanidine HCl)を販売していたが2004.7 Acorda社に権利売却。(Eon Labs, Inc.が2002.6 ジェネリックFDA承認に伴い売上激減) 【日本】テルネリン錠1mg、顆粒0.2％[製造販売／ノバルティス ファーマ株式会社]Ternelin[錠]薬価基準収載年月=1988年4月、販売開始年月=1988年5月；[顆粒]薬価基準収載年月=1994年6月、販売開始年月=1994年7月 【製剤～日本】1錠中塩酸チザニジン1.144mg（チザニジンとして1mg）、顆粒1g中塩酸チザニジン2.288mg（チザニジンとして2mg） 【適応～日本】1.)下記疾患による筋緊張状態の改善－頸肩腕症候群、腰痛症 2.)下記疾患による痙性麻痺－脳血管障害、痙性脊髄麻痺、頸部脊椎症、脳性（小児）麻痺、外傷後遺症（脊髄損傷、頭部外傷）、脊髄小脳変性症、多発性硬化症、筋萎縮性側索硬化症 【用法用量～日本】[1.筋緊張状態の改善の場合]通常成人には、チザニジンとして3mg（錠剤の場合3錠、顆粒剤の場合1.5g）を1日3回に分けて食後に経口投与する。なお、年齢・症状により適宜増減する。 [2. 痙性麻痺の場合] 通常成人には、チザニジンとして1日3mg（錠剤の場合3錠、顆粒剤の場合1.5g）より投与を始め、効果をみながら1日6～9mg（錠剤の場合6～9錠、顆粒剤の場合3～4.5g）まで漸増し、1日3回に分けて食後に経口投与する。なお、年齢・症状により適宜増減する。 【添付文書～日本】テルネリン 製品情報一覧 添付文書 [html] - [pdf] インタビューフォーム[pdf] 【その他】日本ではジェネリック製品１４社、筋緊張緩和剤
●18209-1220 tizanidine HCl by Sandoz[SZ]
AN021[;ATHENA NEUROSCIENCES-US];DS 103-282;SIRDALUD;TERNELIN GRAN ﾃﾙﾈﾘﾝ;TERNELIN TABS ﾃﾙﾈﾘﾝ;TIZ;TIZANIDINE HCL[INN];ZANAFLEX (TABLET);ZANAFLEX;ZANAFLEX[;SANDOZ];塩酸ﾁｻﾞﾆｼﾞﾝ;ﾁｻﾞﾆｼﾞﾝ塩酸塩;ﾃﾙﾈﾘﾝ
《JA》TERNELIN TABS ﾃﾙﾈﾘﾝ（サンド薬品㈱）05-88＊∥TERNELIN TABS ﾃﾙﾈﾘﾝ（三共㈱）05-88＊∥TERNELIN GRAN ﾃﾙﾈﾘﾝ（サンド薬品㈱）07-94＊∥《US》ZANAFLEX (TABLET)（ATHENA NEUROSCIENCES）03-96＊FDA=960311∥ZANAFLEX（ATHENA NEUROSCIENCES）11-96＊FDA=961127∥《WG》SIRDALUD（WANDER AG）05-85＊∥《IT》SIRDALUD（SANDOZ A.G.）08-93＊
チザニジン tizanidine（Zanaflex - Athena Neurosciences ;テルネリン - ノバルティス、他）が、痙性（spasticity）に関連した筋緊張の増加に対する経口治療薬として、米国ＦＤＡにより承認された。 本剤は、短期間の筋弛緩剤として、すでに１２年前よりヨーロッパ及び日本では入手可能になっている。
痙性に対する他の経口剤 － 多発性硬化症又は脊髄に影響を及ぼす他の疾患の患者における、筋緊張の増加及び有痛性筋痙攣の治療に対して、バクロフェン（Lioresal,and others；ギャバロン、リオレサール）が数年前から入手可能となっている（Medical Letter,20:43,1978）。 本剤は、特に長期間の使用により、一部の患者で経口投与で無効になることがある。 また本剤は、鎮静、虚弱増加、及び突然の投薬中止で痙攣及び幻覚を引き起こすことがある。 多くの患者では、移植可能のポンプを使用した、連続鞘内投与のみが有効である。 これらの装置の使用には、感染症を避けるため細心の注意を必要とし、また過量投与により死に至ることがある。 ジアゼパム（Valium and others；セルシン、ホリゾン、他）及びダントロレンナトリウム（Dantrium；ダントリウム）も、痙性の治療に対して経口投与されるが、バクロフェンよりは有効性は劣る。
●2004.5.1 以降 Drugs@FDA
Drug Name(s) =Zanaflex
FDA Application No. =NDA # 021447
Active Ingredient(s)=TIZANIDINE HYDROCHLORIDE
Company =ACORDA
Dosage Form/Route = CAPSULE; ORAL:EQ 2MG BASE ;EQ 4MG BASE ;EQ 6MG BASE
Strength =
- Approval Date=08/29/2002[000] :Label[添付文書]|Letter[承認書]|Review
FDA Application No. =NDA # 020397
Active Ingredient(s)=TIZANIDINE HYDROCHLORIDE
Company =ACORDA
Dosage Form/Route = TABLET; ORAL:EQ 2MG BASE ;EQ 4MG BASE
Strength =
- Approval Date=11/27/1996[000] :
- Approval Date=02/04/2000[004] :|Review [105p,Manufacturing Change or Addition]
- Approval Date=07/28/2006[021] :Label[添付文書]|Letter[承認書]|Labeling Revision
Original Approval or Tentative Approval Date November 27, 1996
Chemical Type 1 New molecular entity (NME)
Review Classification S Standard review drug/O Orphan drug
/2007/9/20/
| | | | |
| 021447 | TIZANIDINE HCl | CAPSULE; ORAL EQ 2MG,4MG,6MG BASE | ZANAFLEX [ACORDA] | Aug 29, 2002 |
| | [Patent Data]6455557 NOV 28,2021 |
| 020397 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | ZANAFLEX [ACORDA] | Nov 27, 1996[4mg]
Feb 4, 2000[2mg] |
| 076283 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [ACTAVIS ELIZABETH] | Jul 12, 2002 |
| 076281 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [ACTAVIS TOTOWA] | Oct 20, 2003 |
| 076282 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [ALPHAPHARM] | Dec 16, 2003 |
| 076371 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [BARR] | Apr 9, 2003 |
| 076416 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [CARACO] | Sep 29, 2003 |
| 076347 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [COREPHARMA] | Oct 11, 2002 |
| 076286 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [DR REDDYS LABS INC] | Jul 3, 2002 |
| 076321 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [IVAX PHARMS] | Sep 30, 2004 |
| 076354 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [MYLAN] | Mar 28, 2003 |
| 076399 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG BASE | TIZANIDINE HYDROCHLORIDE [SANDOZ] | Nov 26, 2002 |
| 076280 | TIZANIDINE HCl | TABLET; ORAL EQ 4MG BASE | TIZANIDINE HYDROCHLORIDE [SANDOZ] | Jun 27, 2002 |
| 076284 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [TEVA] | Jul 3, 2002 |
| 076533 | TIZANIDINE HCl | TABLET; ORAL EQ 2MG,4MG BASE | TIZANIDINE HYDROCHLORIDE [TORPHARM] | Jan 16, 2004 |
●EMEA - Human Medcines
●List of Authorized Products (EPARs)★[A-Z 承認品目]
該当なし
■Products[製品]
Pharmaceutical Best Sellers -主要製品リスト
Products -Pharmaceuticals - 全製品[A-Z]
Sirdalud(R)
(Tizanidine)
Used in the treatment of muscle spasms
独 SIRDALUD 2 mg
英 発売なし
■Diseases & Conditions[疾病]
■Investor Relations
●日本の販売額
売上高は、[2002年度]1837億円（前年比16.6%増）、[2001年度]1575億円（前年比9.4%増）。売り上げ上位10製品（薬価ベース）。
(億円) 2002 2001 2000
テルネリン 80 80(-11.1) 90 筋緊張緩和薬
●News
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★医療関係者
- 添付文書情報以外に、EBMデータ
テルネリン 製品情報一覧
添付文書 2007年1月改訂[html] - 2007年1月改訂[pdf]
インタビューフォーム 2003年3月改訂[pdf]
■Investors Relations
●News & Announcements
Acorda Therapeutics Partners with Cardinal Health to Expand Sales Force for ZANAFLEX CAPSULES[2005.11.10]
Acorda Therapeutics Launches ZANAFLEX(R) CAPSULES for the Management of Spasticity in People with MS and Spinal Cord Injury[2005.4.4]
- Acorda社はZANAFLEX(R) CAPSULES and ZANAFLEX(R) (tizanidine HCl) tablets
を1994.7 Elan Corpから取得。 今回はカプセル剤6mgを新発売。
●SEC Filings
10-K Annual report[2007.3.26] - [pdf] - [word] - [xls]
●Anual Reports
■Pipeline
●Marketed Products
市販製品はZanaflex CapsulesTM (tizanidine hydrochloride) のみ
Zanaflex full prescribing information
●Clinical Stage
Fampridine-SR - multiple sclerosis and spinal cord injury P3
| ($ 000) | 2006 | 2005 | 2004 | 2003/12 | 2003/6 | 2002/6 | 備考 |
| Zanaflex売上 | 26,944 | 4,809 | (4,417) | - | - | - | [tizanidine HCl]筋弛緩剤;痙性麻痺 |
[Zanaflex 2006]
2004.7 We acquired all marketing, sales and distribution rights in the United States
to Zanaflex Capsules and Zanaflex tablets from Elan.
These products contain tizanidine, one of the two leading treatments for spasticity.
Zanaflex Capsules are the only approved capsule formulation of tizanidine and are
protected by a patent that expires in 2021.
These products contain tizanidine, one of the two leading treatments for the management of spasticity. Zanaflex tablets were approved by the FDA in 1996 and lost compound patent protection in 2002. There are currently 12 generic versions of tizanidine tablets on the market. However, substantial brand loyalty remains in the prescriber community for the Zanaflex brand. Approximately 90% of all prescriptions for tizanidine tablets are written as “Zanaflex,” although most are switched automatically at the pharmacy for a generic tizanidine tablet. Zanaflex Capsules were approved by the FDA in 2002, but were never marketed by Elan. We began marketing Zanaflex Capsules in April 2005.
Clinical trials conducted by Elan demonstrated that Zanaflex Capsules, when taken with food, produce average peak levels of tizanidine in a person’s blood that are lower and rise more gradually compared to the peak levels following a similar dose of the tablet form. The FDA recognizes these pharmacokinetic differences and therefore has determined that Zanaflex tablets and generic tizanidine tablets are not therapeutically equivalent, that is, are not AB-rated to Zanaflex Capsules. As a result, under state pharmacy laws, prescriptions written for Zanaflex Capsules may not be filled by the pharmacist with Zanaflex tablets or generic tizanidine tablets, although some substitution does take place in practice. Zanaflex Capsules are available in 2 mg, 4 mg and 6 mg doses, while tablet formulations are only available in 2 mg and 4 mg doses. Our goal is to convert sales of Zanaflex tablets and generic tizanidine tablets to sales of Zanaflex Capsules. We discontinued supply of the 2 mg dose of Zanaflex tablets in February 2006 due to a reduction in demand, and we do not intend to order additional supply of this product in the future. Demand for the 4 mg Zanaflex tablet is also declining, but supports continued supply. The 6 mg capsule gives patients and physicians an additional dosing choice and an opportunity to reduce the number of pills a patient must take daily. In addition, many patients may find capsules easier to swallow than tablets. Also, people who have difficulty swallowing may open the capsule and sprinkle it on food. The pharmacokinetic effect of sprinkling contents of the capsule on food, however, is different from when the intact capsule is taken with food.
In 2006, retail sales of Zanaflex capsules, Zanaflex tablets and generic equivalents of Zanaflex tablets (tizanidine) totaled approximately $290 million. For the same period, retail sales of Baclofen totaled approximately $181 million, for an approximate aggregate market of $471 million. The vast majority of these prescriptions were written by a relatively small group of prescribers. Specialists accounted for approximately 40% of tizanidine prescribing. High-volume specialist prescribers were responsible for approximately two or three-and-one-half times more prescriptions per physician than high-volume primary care prescribers. We believe that our internal specialty sales force including our tele-sales team, will be able to reach virtually all of these high-volume prescribers.
[Spasticity 2006]
Spasticity refers to the often painful involuntary tensing, stiffening or contracting of muscles. Spasticity is not a disease but a symptom of other conditions, such as MS, SCI, stroke, traumatic brain injury and cerebral palsy, where portions of the nervous system that control voluntary movement have been damaged. This damage results in the nerve cells in the spinal cord becoming disconnected from controlling centers in the brain and, as a result, transmitting unregulated impulses to the muscles. People who have spasticity may experience it intermittently?it may be triggered by a stimulus, such as pain, pressure sores, cold weather or a urinary tract infection. The majority of people with MS and SCI experience some form of spasticity, as do many people following stroke or brain injuries. We Move, a non-profit organization dedicated to movement disorders, estimates that spasticity affects approximately 500,000 people in the United States and over 12 million worldwide.
Current treatments for spasticity are focused on reducing spasm frequency, pain or irritating stimuli that can provoke spasticity. Treatment of spasticity often involves a combination of physical therapy and oral medications. Baclofen and tizanidine, the active ingredient in the Zanaflex products, are the two most frequently prescribed oral medications for spasticity. For more intractable spasticity, treatments sometimes include surgical or chemical destruction of nerve roots in the affected area.
|