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(19) TZZ __T (11) EP 2 554 184 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 45/00 (2006.01) A61K 45/06 (2006.01) 26.10.2016 Bulletin 2016/43 A61K 31/137 (2006.01) A61K 31/222 (2006.01) A61K 31/4174 (2006.01) A61K 31/4415 (2006.01) (2006.01) (21) Application number: 11765663.7 A61P 17/00 (22) Date of filing: 30.03.2011 (86) International application number: PCT/JP2011/058071 (87) International publication number: WO 2011/125763 (13.10.2011 Gazette 2011/41) (54) PREVENTIVE AND/OR REMEDY FOR HAND AND FOOT SYNDROME MITTEL ZUR VERHINDERUNG UND/ODER HEILUNG DES HAND-FUSS-SYNDROMS AGENT PRÉVENTIF ET/OU REMÈDE POUR LE SYNDROME D’ENFLURE DOULOUREUSE DES MAINS ET DES PIEDS (84) Designated Contracting States: JP-A- 2008 506 674 JP-A- 2009 542 581 AL AT BE BG CH CY CZ DE DK EE ES FI FR GB JP-A- 2010 018 564 GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR • JACOBI U ET AL: "Release of doxorubicin in sweat: first step to induce the palmar-plantar (30) Priority: 31.03.2010 JP 2010082379 erythrodysesthesia syndrome?", ANNALS OF 08.11.2010 JP 2010250168 ONCOLOGY,KLUWER, DORDRECHT, NL, vol. 16, no. 7, 27 April 2005 (2005-04-27) , pages (43) Date of publication of application: 1210-1211, XP009134287, ISSN: 0923-7534, DOI: 06.02.2013 Bulletin 2013/06 10.1093/ANNONC/MDI204 • HEALD, R.C.: "Anticholinergic drugs as (73) Proprietor: ONO Pharmaceutical Co., Ltd. antiperspirants", AMERICAN PERFUMER AND Osaka-shi, Osaka 541-8526 (JP) COSMETICS, vol. 81, no. 10, 1966, pages 95-8, XP8058047, (72) Inventors: • WEBSTER-GANDY ET AL: "Palmar-plantar • ISHIZAKA, Kazuhiro erythrodysesthesia (PPE): A literature review Kanagawa 2138507 (JP) with commentary on experience in a cancer • NOMIZU, Tadashi centre", EUROPEAN JOURNAL OF ONCOLOGY Koriyama-shi NURSING, CHURCHILL LIVINGSTONE, Fukushima 963-8846 (JP) AMSTERDAM, NL, vol. 11, no. 3, 1 July 2007 • KITAO, Aya (2007-07-01), pages238-246, XP022136232, ISSN: Osaka-shi 1462-3889 Osaka 541-8526 (JP) • LOKESH JAIN ET AL: "Lack of Association Between Excretion of Sorafenib in Sweat and (74) Representative: Jones, Nicholas Andrew et al Hand-Foot Skin Reaction", Withers & Rogers LLP PHARMACOTHERAPY, vol. 30, no. 1, January 4 More London Riverside 2010 (2010-01), pages 52-56, XP055070331, ISSN: London, SE1 2AU (GB) 0277-0008, DOI: 10.1592/phco.30.1.52 • HEALD, R.C.: ’Anticholinergic drugs as (56) References cited: antiperspirants’ AMERICAN PERFUMER AND EP-A1- 2 368 549 WO-A2-2007/046102 COSMETICS vol. 81, no. 10, 1966, pages 95 - 98, WO-A2-2007/046102 WO-A2-2009/150408 XP008058047 Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 2 554 184 B1 Printed by Jouve, 75001 PARIS (FR) (Cont. next page) EP 2 554 184 B1 • M. L. HENSLEY ET AL.: ’Sunitinib malate in the • T. AHMAD ET AL.: ’Kinase Inhibition with BAY treatment of recurrent or persistent uterine 43-9006 in Renal Cell Carcinoma’ CLINICAL leiomyosarcoma: A Gynecologic Oncology CANCER RESEARCH vol. 10, 2004, pages 6388S Group phase II study’ GYNECOLOGIC - 6392S, XP002362669 ONCOLOGY vol. 115, 2009, pages 460 - 465, XP026733163 2 EP 2 554 184 B1 Description TECHNICAL FIELD 5 [0001] The present invention relates to an agent for the prevention and/or treatment of Hand-Foot Syndrome comprising a compound with anticholinergic activity. BACKGROUND ART 10 [0002] Hand-Foot Syndrome is a skin disease developed as a side effect of anti-cancer drug treatment and therefore is an indicator of dose limiting factor of anti-cancer drug. Favorite sites of Hand-Foot Syndrome are distal portions of the extremities, especially, palms, soles, and nails and it often appears at these sites with erythema or pigmentation. Patients with mild symptoms (grade 1 of Hand-Foot Syndrome judging criteria) would not be limited in activities of daily living, however in severe cases, patients would develop swelling or redness with pain (grade 2 of said criteria). In addition, 15 cornification or desquamation of palms and soles would become prominent, and sometimes skin fissure would be developed which is accompanied by hyperesthesia. Patients with such conditions might experience difficulty in holding things or in ambulation because of the pain (grade 3 of said criteria). [0003] Pathogenic mechanism of Hand-Foot Syndrome is currently unexplained. For example, there are some factors such as inhibition of proliferating ability of cutaneous basal cell, leakage of anti-cancer drug from blood vessels e.g( ., 20 see Patent Document 1), or secretion of anti-cancer drug from eccrine gland ( e.g., see Nonpatent Document 1), which are suggested as one of the possible causes of Hand-Foot Syndrome, however, causal connection between pathogenesis of the same and anti-cancer drug is yet unknown. [0004] As mentioned above, pathogenic mechanism of Hand-Foot Syndrome is unknown and therefore no prevention method or treatment method is established. Current treatment method of Hand-Foot Syndrome is mainly symptomatic 25 treatment relying on empirical treatment such as: resting limbs, or in the situation of severe swelling, cooling limbs or elevating limbs; local treatment using external formulation such as urea ointment, heparinoid preparation or vitamin ointments for moisturizing purpose; local treatment using topical steroid with anti-inflammatory effect; systemic treatment using internal remedy such as prednisolone, dexamethasone, or pyridoxine hydrochloride (Vitamin B6) (e.g., see Non- patent Document 2); and for treatments of symptoms on nail, washing, protecting with gauze, taping, onychoplasty, 30 artificial nail, cryosurgery, and so on. [0005] In addition to the above, for example, following treatments are suggested; usage of local DMSO for the treatment of Hand-Foot Syndrome caused by liposomal doxorubicin (e.g., see Patent Document 1), usage of dihydropyrimidine dehydrogenase, thymidine phosphorylase, and/or uridine phosphorylase enzyme inhibitor for the treatment of Hand- Foot Syndrome caused by fluorouracil or its precursor (e.g., see Patent Document 2), and usage of cyclin-dependent 35 kinase II inhibitor for prevention and/or reduction of severity of epithelial cytotoxicity side effects including Hand-Foot Syndrome caused by chemotherapy and/or radiation therapy (e.g., see Patent Document 3). [0006] However, effects of aforementioned treatments are not satisfactory. [0007] In addition, there are cases where administration of responsible agents might have to be interrupted as there is no means to treat such symptoms. Nevertheless, for example, at Phase 2 clinical study of capecitabine in Japan, it 40 is reported that the period for recovery of Hand-Foot Syndrome for patients with the highest Hand-Foot Syndrome judging criteria grade of 3 after interruption is about two to three months in average e.g( ., see Nonpatent Document 3), which shows the fact that it takes a long time for its recovery even with interruption. [0008] Thus more effective drug product with instant results is demanded. [0009] On the other hand, as for Hand-Foot Syndrome, there are some reports indicating the connectivity of its patho- 45 genesis with sweat. For example, Patent Document 4 discloses adhesive skin patch for patients under anti-cancer drug treatment, which contains an adhesive base, and at least one compound selected from the group consisting of oil, polyhydric alcohol, and hydrophilic high-molecular compound. In which, it is described that aforementioned skin adhesive patch is effective against Hand-Foot Syndrome by preventing sweat or sebum which contains such an anti-cancer drug to be stored in skin and by absorbing sweat or sebum which contains such an anti-cancer drug. However, this document 50 focused on the fact that use of certain skin adhesive patches to remove anti-cancer drug contained in sweat or sebum is effective for Hand-Foot Syndrome. Furthermore, in this document, anti-cancer drug that caused the pathogenesis of Hand-Foot Syndrome is not specified and it is not described in this document that which route of blood vessels and eccrine glands is important as a secretion pathway of anti-cancer drug to sweat or sebum. [0010] On the other hand, it is described in Nonpatent Document 1 that anti-cancer drug doxorubicin was detected in 55 the sweat from patients with Hand-Foot Syndrome who were administered with such a drug and that they were associated with hyperhidrosis, which implies the connectivity of Hand-Foot Syndrome with hyperhidrosis. However, it is not validated in this document the connectivity of pathogenesis of Hand-Foot Syndrome with drug substance in sweat. This document suggests usage of antiperspirant such as iontophoresis or aluminum chloride to suppress pathogenesis of Hand-Foot 3 EP 2 554 184 B1 Syndrome as the nature of this document is to associate Hand-Foot Syndrome with sweat. Although it has been five years since this document was published, it shows no successful experience of suppressing pathogenesis of Hand-Foot Syndrome using such antiperspirant. [0011] Currently, causal association between Hand-Foot Syndrome and secretion of drug substance into sweat is 5 being questioned (e.g., see Nonpatent Document 4). It was described in this document that drug substance was not detected in sweat from patients with Hand-Foot Syndrome caused by anti-cancer drug sorafenib administration, and therefore there is no relationship between Hand-Foot Syndrome caused by sorafenib and secretion of drug substance in sweat.
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    Scripps Health Formulary July 2016 Foreword Pharmacy and Therapeutics Committee. MedImpact approves such multi- This document represents the efforts of the MedImpact Healthcare Systems source drugs for addition to the MAC list based on the following criteria: Pharmacy and Therapeutics (P & T) and Formulary Committees to provide physicians A multi-source drug product manufactured by at least one (1) nationally and pharmacists with a method to evaluate the safety, efficacy and cost-effectiveness marketed company. of commercially available drug products. A structured approach to the drug selection At least one (1) of the generic manufacturer’s products must have an “A” process is essential in ensuring continuing patient access to rational drug therapies. rating or the generic product has been determined to be unassociated with The ultimate goal of the Portfolio Formulary is to provide a process and framework to efficacy, safety or bioequivalency concerns by the MedImpact P & T support the dynamic evolution of this document to guide prescribing decisions that Committee. reflect the most current clinical consensus associated with drug therapy decisions. Drug product will be approved for generic substitution by the MedImpact P & T Committee. This is accomplished through the auspices of the MedImpact P & T and Formulary Committees. These committees meet quarterly and more often as warranted to ensure This list is reviewed and updated periodically based on the clinical literature and clinical relevancy of the Formulary. To accommodate changes to this document, pharmacokinetic characteristics of currently available versions of these drug updates are made accessible as necessary. products. As you use this Formulary, you are encouraged to review the information and provide If a member or physician requests a brand name product in lieu of an approved your input and comments to the MedImpact P & T and Formulary Committees.
  • Toviaz) Reference Number: ERX.ST.16 Effective Date: 09.01.17 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log

    Toviaz) Reference Number: ERX.ST.16 Effective Date: 09.01.17 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log

    Clinical Policy: Fesoterodine (Toviaz) Reference Number: ERX.ST.16 Effective Date: 09.01.17 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Fesoterodine (Toviaz®) is a muscarinic antagonist. FDA approved indication Toviaz is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Toviaz is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Step Therapy for Toviaz (must meet all): 1. Age ≥ 18 years; 2. Previous use of 2 formulary generic overactive bladder agents, each trialed for 30 days, unless all are contraindicated or clinically significant adverse effects are experienced; 3. Previous use of Myrbetriq and Vesicare, each trialed for 30 days, unless both are contraindicated or clinically significant adverse effects are experienced; 4. One of the aforementioned trials occurred within the past 6 months, unless all are contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 8 mg per day (1 tablet per day). Approval duration: 12 months II. Continued Therapy A. Step Therapy for Toviaz (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or member has previously met initial approval criteria; 2. If request is for a dose increase, new dose does not exceed 8 mg per day (1 tablet per day).