MLリソース：ヘルペス治療剤
【日本語版コメント】
単純ヘルペスの場合、治療開始後１０日～２週間で治癒するのが通常で重症化することがないせいか、受療率は低い。 日本では800万人が罹患と推定されるのに実際通院するのは２万人足らず。
【市場】
主要製品世界売上2001年度バラシクロビル製剤Valtrex [GSK] 423億円(Euro 350 million)[+42]、アシクロビル製剤 Zovirax [GSK] 358億円(E296M)[-19]、famciclovir製剤 Famvir [Novartis] 267億円(323 CHF Million)(-)。GSKの独占状態(Novartis製品はGSKが供給)。
日本では、ゾビラックス[GSK] 270億円、バルトレックス[GSK] 80, アラセナA[持田] 31(+27)
【開発中の新薬】
特にめぼしいものはない。 【解説資料】
単純ヘルペスは口唇型と性器型に分けられ、口唇型は主として１型，性器型は同２型により起こる。
１型による初感染は乳幼児期に起こり、大部分は不顕性に終るが、ときに歯肉口内炎を発症させる。またごく稀に角膜炎、脳炎、Kaposi水痘様疹を起こす。その後、神経節に潜伏し、疲労、ストレスなどにより再活性化し、口唇周囲などに水疱を生じる。
[治療]抗ウイルス薬にはアシクロビルやビダラビン（Ara-A)があるが、前者の方が有効とされる。
■①単純ヘルペスウイルス herpes simplex virus（HSV）
■産経新聞:口唇ヘルペス：専門家のアドバイス
■COLD SORE (Fever Blister; Herpes Simplex) [MDAdvice]解説ページ
■Learn about Cold Sores
【疫学資料】
「患者調査」によると日本の1999年度患者数は、性器ヘルペス 1千人、単純ヘルペス19千人、帯状疱疹34千人、合計54千人。
米国では人口の80%が口唇ヘルペスウイルスのキャリアで、毎年その20-40%、少なくとも5000万人が発病する。【臨床ガイドライン】
【総説】 多施設合同による帯状疱疹の年間統計解析の試み(2000年4月～2001年3月) by 石川 博康(山形県立中央病院皮膚科)ら：(日皮会誌：113(8)1229-1239,2003) 【ニュース・トピックス】
【リソース・オンライン雑誌】
■MEDLINEplus: Herpes Simplex|MEDLINEplus: Shingles (Herpes Zoster)
【主要サイト】
●GSK:口唇ヘルペス
■American Herpes Foundation[各種ヘルペス情報（一般向け、専門家向け）を提供。 AHF Monitor[季刊]は無料閲覧可]■HRC :Herpes Resource Center[ヘルペス関連の解説資料のWEB発行、リンク頁]■IHMF: International Herpes Management Forum[online雑誌 HERPES[年３回]は全文無料閲覧可。]■HerpesWeb[性器ヘルペス関連情報、診療ガイドラインがある。]
●解説
■①単純ヘルペスウイルス herpes simplex virus（HSV）
●口唇型と性器型に分けられ、口唇型は主として単純ヘルペスウイルス１型，性器型は同２型により起こる。
[略]
●１型による初感染は乳幼児期に起こり、大部分は不顕性に終るが、ときに歯肉口内炎を発症させる。またごく稀に角膜炎、脳炎、Kaposi水痘様疹を起こす。その後、神経節に潜伏し、疲労、ストレスなどにより再活性化し、口唇周囲などに水疱を生じる。
[略]
[治療]抗ウイルス薬にはアシクロビルやビダラビン（Ara-A)があるが、前者の方が有効である。
[略]
■産経新聞:口唇ヘルペス
専門家のアドバイス
口唇ヘルペスといわれる病気のようですね。この病気は最初、単純ヘルペスウイルス（ＨＳＶ）が小児期に咽頭から感染します。このときには発熱など、いわゆるかぜの症状があって、いったんおさまります。
[略]
治療法はゾビラックス（アシクロビル）のような抗ウイルス薬が有効ですが、これらはＨＳＶの増殖を抑えはしますが、現在のところ遺伝子の形でいるウイルスを撲滅する方法はありません。ですから、この病気に取りつかれた人は、いかに再発を少なく、軽くするかに努めた方がよいことになります。
[略]
（駿河台日本大学病院院長 鈴木太）
●COLD SORE (Fever Blister; Herpes Simplex) [MDAdvice]解説ページ
●データ
■[PhRMA] -New Medicines in Development
2002.10.2現在
●Herpes Infections
Drug Name
(Proprietary name/Generic name)Indications Addressed Company Development Status Notes PNU-243672
none / PNU-243672Herpes Infections Pharmacia
Peapack, NJPhase I
●Herpes Labialis
Drug Name
(Proprietary name/Generic name)Indications Addressed Company Development Status Notes ME-609 cream
none / ME-609 creamHerpes Labialis Medivir
Huddinge, SwedenPhase II completed NVTL0001
none / NVTL0001Herpes Labialis Novactyl
St. Louis, MOPhase I
●Herpes Simplex
Drug Name
(Proprietary name/Generic name)Indications Addressed Company Development Status Notes herpes simplex vaccine
none / herpes simplex vaccineHerpes Simplex Wyeth Pharmaceuticals
Philadelphia, PAPhase I Valtrex
Valtrex / valacyclovirHerpes Simplex GlaxoSmithKline
Research Triangle Park, NCPhase III
●Herpes Zoster
Drug Name
(Proprietary name/Generic name)Indications Addressed Company Development Status Notes low-dose oral interferon-alpha
none / low-dose oral interferon-alphaHerpes Zoster Atrix Laboratories
Fort Collins, COPhase I MIV-606
none / MIV-606Herpes Zoster Medivir
Huddinge, SwedenPhase II
●平成１１年患者調査の概況
Ａ60 肛門性器ヘルペスウイルス[単純ヘルペス]感染症 Ａ60.0 性器及び尿路性器のヘルペスウイルス感染症 1 Ａ60.1 肛門周囲皮膚及び直腸のヘルペスウイルス感染症 Ａ60.9 肛門性器ヘルペスウイルス感染症,詳細不明 皮膚及び粘膜病変を特徴とするウイルス感染症(Ｂ00－Ｂ09) Ｂ00 ヘルペスウイルス[単純ヘルペス]感染症 Ｂ00.0 疱疹性湿疹 Ｂ00.1 ヘルペスウイルス(性)小水疱性皮膚炎 9 Ｂ00.2 ヘルペスウイルス(性)歯肉口内炎及び咽頭扁桃炎 1 Ｂ00.3+ ヘルペスウイルス(性)髄膜炎(Ｇ02.0*) 0 Ｂ00.4+ ヘルペスウイルス(性)脳炎(Ｇ05.1*) 0 Ｂ00.5+ ヘルペスウイルス(性)眼疾患 7 Ｂ00.7 播種性ヘルペスウイルス疾患 Ｂ00.8 その他の型のヘルペスウイルス感染症 Ｂ00.9 ヘルペスウイルス感染症,詳細不明 2 Ｂ02 帯状疱疹[帯状ヘルペス] Ｂ02.0+ 帯状疱疹(性)脳炎(Ｇ05.1*) Ｂ02.1+ 帯状疱疹(性)髄膜炎(Ｇ02.0*) Ｂ02.2+ 帯状疱疹,その他の神経系合併症を伴うもの 7 Ｂ02.3+ 帯状疱疹(性)眼疾患 Ｂ02.7 播種性帯状疱疹 Ｂ02.8 帯状疱疹,その他の合併症を伴うもの Ｂ02.9 帯状疱疹,合併症を伴わないもの 27
●臨床ガイドラインなど
●総説記事・文献
●ニュース・トピックス
●リンク＆リソース
■MEDLINEplus: Herpes Simplex
Contents of this page: News From the NIH General/Overviews Clinical Trials Coping Diagnosis/Symptoms Prevention/Screening Specific Conditions/Aspects Treatment Directories Organizations Children Teenagers The primary NIH organization for research on Herpes Simplex is the National Institute of Allergy and Infectious Diseases Search MEDLINE for recent research articles on Herpes Simplex: ・ General ・ Genital Herpes You may also be interested in these MEDLINEplus related pages: ・ Sexually Transmitted Diseases ・ Shingles (Herpes Zoster) ・ Infections ●Latest News Earlier Sex Linked to Herpes Infections (10/03/2002, United Press International) Drug Reduces Spread of Genital Herpes (09/27/2002, United Press International) ●From the National Institutes of Health Genital Herpes (National Institute of Allergy and Infectious Diseases) ●General/Overviews Genital Herpes (Centers for Disease Control and Prevention) Genital Herpes (National Women's Health Information Center) Genital Herpes: A Hidden Epidemic (Food and Drug Administration) Herpes: Get the Facts (American Social Health Association) Also available in: Spanish Herpes: What It Is and How to Deal With It (American Academy of Family Physicians) ●Clinical Trials ClinicalTrials.gov: Herpes Genitalis (National Institutes of Health) ClinicalTrials.gov: Herpes Simplex (National Institutes of Health) ●Coping When to Tell a Partner (American Social Health Association) Also available in: Spanish Why Tell a Partner? (American Social Health Association) Also available in: Spanish ●Diagnosis/Symptoms Tests to Diagnose Herpes (American Social Health Association) ●Prevention/Screening Condoms and Sexually Transmitted Diseases. . . Especially AIDS (Food and Drug Administration) Condoms: A User's Guide (Mayo Foundation for Medical Education and Research) New CDC Treatment Guidelines Critical to Preventing Health Consequences of Sexually Transmitted Diseases (Centers for Disease Control and Prevention) Right Way to Use a Condom (American Social Health Association) ●Specific Conditions/Aspects What Is a Canker Sore? (Mayo Foundation for Medical Education and Research) What Is a Cold Sore? (Mayo Foundation for Medical Education and Research) ●Treatment Antiviral Drug Sharply Reduces Return of Herpes of the Eye (National Eye Institute) Treatment and Therapy (American Social Health Association) ●Directories Herpes: Local HELP (Support) Groups (American Social Health Association) ●Organizations American Social Health Association National Institute of Allergy and Infectious Diseases ●Children Coping with Cold Sores (Nemours Foundation) Herpes Simplex (Nemours Foundation) ●Teenagers Genital Herpes (Nemours Foundation) Page last updated: 03 October 2002 Topic last reviewed: 01 October 2002
■MEDLINEplus: Shingles (Herpes Zoster)
Contents of this page: From the NIH General/Overviews Clinical Trials Pictures/Diagrams Prevention/Screening Research Specific Conditions/Aspects Organizations The primary NIH organization for research on Shingles (Herpes Zoster) is the National Institute of Allergy and Infectious Diseases Search MEDLINE for recent research articles on Shingles (Herpes Zoster): ・ General ・ Diagnosis ・ Causes ・ Therapy You may also be interested in these MEDLINEplus related pages: ・ Chickenpox ・ Brain and Nervous System ・ Infections ・ Seniors' Health ●From the National Institutes of Health Shingles (National Institute of Neurological Disorders and Stroke) Shingles: Hope Through Research (National Institute of Neurological Disorders and Stroke) ●General/Overviews Herpes Zoster (American Academy of Dermatology) Shingles (Patient Education Institute) - - requires Flash plug-in Shingles: An Unwelcome Encore (Food and Drug Administration) ●Clinical Trials ClinicalTrials.gov: Herpes Zoster (National Institutes of Health) ●Pictures/Diagrams Photos of Shingles (National Institute of Allergy and Infectious Diseases) ●Prevention/Screening Shingles Prevention Study: Common Questions (National Institute of Allergy and Infectious Diseases) Shingles Prevention Study: Overview (National Institute of Allergy and Infectious Diseases) ●Research Herpes Virus Hijacks Cell's Own Transportation System (National Institute of General Medical Sciences) Potential Shingles Vaccine (National Institutes of Health) ●Specific Conditions/Aspects Ramsay Hunt Syndrome Type I (National Institute of Neurological Disorders and Stroke) Shingles (Acute Herpes Zoster) and Postherpetic Neuralgia (PHN) (Beth Israel Medical Center, Dept. of Pain Medicine and Palliative Care) ●Organizations National Center for Infectious Diseases National Institute of Allergy and Infectious Diseases National Institute of Neurological Disorders and Stroke VZV Research Foundation Page last updated: 03 October 2002 Topic last reviewed: 30 September 2002
●主要サイト
■IHMF: International Herpes Management Forum
online雑誌 HERPES[年３回]は全文無料閲覧可。 IHMF Activities Monographs & Guidelines Herpes Journal Online Learnig Zone Regional Management Forum Physician's Resources 10th Annual Meeting Patients' Resources GSK Elion Awards Genital Herpes Global Management Survey healthfinder
■HerpesWeb 性器ヘルペス関連情報、診療ガイドラインがある。
Global connections Healthcare professionals GENERAL VISITORS MENU This site has been developed with aid of an educational grant from Glaxo-SmithKleine
■American Herpes Foundation
各種ヘルペス情報（一般向け、専門家向け）を提供。 AHF Monitor[季刊]は無料閲覧可 Educating Your Patients Clinician Information AHF Clinical Educational Initiatives AHF Research Awards Conferences The Herpes Monotor AHF Online CME Hereps Resources Subscribe Today
●www.herpeslabialis.com
解説ページAbout lips and cold sores
% of Americans have the cold sore virus, with 55 million expressing recurrent symptoms
Pure lip remedy and Pure Lip Preventionを販売するPure Lip社の専門サイト
http://www.oralherpes.com/">http://www.oralherpes.com/も同社のサイト
[1092]●製品 docosanol (Abreva cream[Avenir Pharmaceuticals]) 日本語版註）docosanol (Abreva cream[Avenir Pharmaceuticals])
【別名】1-DOCOSANOL;DOCOSANOL,1-;LIDAKOL;N-DOCOSANOL;ドコサノール，１;ライダコール 【開発元】LIDAK [DBR_ID]42740
【化学名】n-docosanol, also known as behenyl alcohol, a saturated 22-carbon aliphatic alcohol
【承認】FDA承認=25-JUL-00 ,発売=Oct-2000[by GSK];【製剤】 【適応】cold sore[herpes simplexの口語]/fever blister[熱性疱疹(口唇の単純疱疹を表す口語)] treatment 【製品情報】Abreva 【添付文書】http://www.fda.gov/cder/foi/label/2000/20941lbl.pdf 【日本】未開発 【その他】以前グレラン製薬㈱から報告されたことがある。
米国でOTC用にCold sore製品としてFDA承認をうけた唯一の製品
●承認データ：FDA
情報ソース●FDA New Drug Approvals for July 2000 Original Application #: 020941 Approval Date: 25-JUL-00 Trade Name: ABREVA Chemical Type: 1 Therapeutic Potential: S Dosage Form: CREAM Applicant: AVANIR PHARMACEUTICALS Active Ingredient(s): DOCOSANOL OTC/RX Status: OTC Indication(s): For the treatment cold sore[herpes simplexの口語]/fever blister [熱性疱疹(口唇の単純疱疹を表す口語)] ●Drug Approvals Abreva Cream, Topical, OTC Avanir Pharmaceutical Application #=NDA 20 941 Approval Date=7/25/00 Letter Posted=12/6/00 Label Posted =12/6/00 Review Posted= Abreva Indication: cold sore/fever blister treatment
■メーカーサイト
●Avanir Pharmaceuticals - http://www.avanir.com/; 創立1988年、医薬研究開発型ベンチャー。 慢性疾患を対象 Abrevaは、OTC薬としてFDA承認、GSKにより米、加で販売。 ●開発品目 Neurodex[AVP-923] P2/3 神経変性疾患治療薬[Lou Gehrig's disease] ●News ・August 5, 2002 AVANIR Signs Agreement With Bruno Farmaceutici To Market Docosanol 10% Cream in Italy Abreva(TM) Approved for Marketing in Canada[2002.5.28] AVANIR's Docosanol 10% Cream Approved for Marketing in Israel[2002.5.31] AVANIR's Docosanol 10% Cream Approved for Marketing in Korea[2002.5.29] AVANIR Pharmaceuticals Files for Marketing Approval Of Docosanol 10% Cream in Europe[2002.5.7] - スエーデンで本日申請。Reviewに12カ月要する見込み。 欧州cold sore製品市場は年間$90 million以上と推定。 ・May 2, 2002 AVANIR Pharmaceuticals Receives CalTIP Grant to Develop a Docosanol-Based Genital Herpes Treatment ・March 20, 2002 AVANIR Pharmaceuticals Awarded $1 Million Research Grant To Develop a New Docosanol Formulation for Genital Herpes Treatment ・March 14, 2002 AVANIR CEO Reports Progress on Patent Extension Request for Abreva(TM) At Company's Annual Meeting ・January 30, 2002 AVANIR Pharmaceuticals Expands Docosanol Distribution Through Licensing Agreement With Biopharm Group ・December 10, 2001 AVANIR Pharmaceuticals Earns Final $5 Million Milestone Payment From GlaxoSmithKline ・October 9, 2001 AVANIR Pharmaceuticals Reports ABREVA(TM) Market Performance; ABREVA(TM) Number One Pharmacist Recommended Brand ・October 8, 2001 AVANIR Pharmaceuticals Announces Potential Docosanol Collaborations At UBS Warburg Global Life Sciences Conference Today ・September 19, 2001 AVANIR Pharmaceuticals Receives $5 Million Milestone Payment From GlaxoSmithKline for ABREVA(TM) Licensing ・September 11, 2001 AVANIR Pharmaceuticals to Present New Docosanol Data at Premier International Scientific Conference AVANIR Pharmaceuticals Reports Fourth Quarter and Fiscal 2001 Year-End Results[2001.12.18] - 2001/9期; GSKからのAbreva北米売上に対するRoyaltyは2.5 Millionだが、milestone payments $10 millionがある。
●Avanir - Product Research and Development: Docosanol 10% Cream - http://www.avanir.com/productrd/ A broad spectrum, topical cream for the treatment of cold sores and fever blisters. ★Product Description: Docosanol 10% cream is a topical treatment for recurrent oral-facial herpes simplex episodes (cold sores or fever blisters). The active ingredient is n-docosanol, also known as behenyl alcohol, a saturated 22-carbon aliphatic alcohol which exhibits antiviral activity against many lipid enveloped viruses including herpes simplex virus (HSV). ★Development Stage: The FDA has approved docosanol 10% cream as a treatment for cold sores and fever blisters. It is being marketed by SmithKline Beecham and will be available without prescription in the over-the-counter market under the trade name Abreva. ★Disease Description: Roughly 50 million Americans suffer from fever blisters or cold sores with more than 100 million episodes estimated annually. The medical term for the condition is recurrent herpes simplex labialis. It is caused by a virus (HSV) that lies dormant in the nerve ganglia. Upon reactivation by various stimuli, the virus travels along nerve pathways towards the lips and mouth where it emerges as a lesion or blister. The disfiguring lesions typically last 7 to 10 days. [以下略]
●Abreva
- http://www.abreva.com/ Learn about Cold Sores | Learn more about ABREVA | Buy ABREVA Now Home | Contact Us | Site Map
■一般サイトから
●Abreva Cream [FDA Approval] FDA News (Non-evaluative reports of recent FDA approvals or other FDA actions or postings.)
FDA APPROVAL DATE: 07/25/2000 [FDA Approval]
DRUG: Abreva Cream (docosanol) [previously known as "Lidakol" and "N-docosanol"]
COMPANY: Avanir Pharmaceutical (to be marketed in the U.S. by SmithKline Beecham)
FDA-APPROVED INDICATION: "cold sore/fever blister treatment" [per FDA Website]
ANTICIPATED AVAILABILITY DATE: [not known at the time of this writing (08/16/2000)]
ANTICIPATED COST: [not known at the time of this writing (08/16/2000)]
PACKAGE LABELING: [not available at the time of this writing (08/16/2000)]
When/If the package labeling is posted on the FDA Web-site, it will probably be located at http://www.fda.gov/cder/foi/label/1999/20941lbl.pdf.
[This would be a pdf which can be read using Adobe Acrobat. Acrobat can be downloaded from http://www.adobe.com/prodindex/acrobat/readstep.html].
PRESCRIPTION STATUS: Over-the-counter.
--------------------------------------------------------------------------------
●NOTES FROM PRESS RELEASE:
In a press release, Avanir Pharmaceuticals announced U.S. FDA approval for docosanol 10% cream, "a topical treatment for recurrent oral-facial herpes simplex infections, commonly known as cold sores or fever blisters." The FDA has approved the product to be sold without prescription.
The press release states that 80% of U.S. adults "are carriers of the virus that causes cold sores. Each year, 20 to 40 percent of these -- more than 50 million adults -- develop symptomatic episodes, characterized by the formation of a blister on the upper or lower lip. The number of treatable episodes ranges from 100 to 130 million outbreaks annually, with 70 to 80% of these episodes treated by products in the over-the-counter (OTC) market."
Describing clinical trials with docosanol 10% cream, the press release "significantly reduced the healing time of patients' cold sore episodes compared to placebo (p<0.01). In addition, patients treated with docosanol demonstrated statistically significant reductions in the duration of associated symptoms of pain and/or burning, itching or tingling when compared to placebo (p<0.01)."
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- 関連●抗ウイルス剤
- 1062★99.09.24★性感染症治療薬●1062追加メモ[470KB]
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- ■2002-------------------------------------------
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★1143★18/23★02.11.11★095★口唇ヘルペス治療薬バラシクロビル（Valtrex）/2p●MLリソース：抗ウイルス剤|MLリソース：ヘルペス治療剤
- ■2000-------------------------------------------
- ■1997-------------------------------------------
- 1003★13/13★97.06.20★057★口唇ヘルペスに対する局所用ペンシクロビル
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- 一覧へ戻る。
- ホームへ戻る。
- 作成：2000.12.23 最終更新:2002.12.16 小菅博之
The Medical Letter日本語版
●追加メモ to 1092,1143
On Drugs and Therapeutics
- このページは［The Medical Letter日本語版］の補足データとして添付しています。 ［The Medical Letter］は新薬の厳正な評価誌であり、ここに収録される製品は新しくＦＤＡ承認された新薬に対する評価を中心としています。
- 企画意図の第一は、収録製品についての米国内・世界での背景情報です。 例えば、各製品の承認関連データ、競合品との、あるいは市場での位置づけ、疫学データなど。 第二は、日本での該当製品や市場の情報。 市場の主要製品売上、開発中の治験薬等。 調査項目としては、■製品■解説■データ■臨床ガイドラインなど■総説記事・文献■ニュース・トピックス■リンク■主要サイト