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WO 2014/165136 Al 9 October 2014 (09.10.2014) P O P C T

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WO 2014/165136 Al 9 October 2014 (09.10.2014) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2014/165136 Al 9 October 2014 (09.10.2014) P O P C T (51) International Patent Classification: (74) Agents: SERVANCE, Squire, J. et al; Morgan Lewis & A61M 5/178 (2006.01) A61P 19/00 (2006.01) Bockius LLP, 1701 Market Street, Philadelphia, PA 19103 A61P 5/00 (2006.01) A61P 37/00 (2006.01) (US). A61P 17/00 (2006.01) (81) Designated States (unless otherwise indicated, for every (21) International Application Number: kind of national protection available): AE, AG, AL, AM, PCT/US2014/024530 AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (22) International Filing Date: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, 12 March 2014 (12.03.2014) HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (25) Filing Language: English KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (26) Publication Language: English OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (30) Priority Data: SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, 61/778,398 12 March 2013 (12.03.2013) US TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (71) Applicant: ANTARES PHARMA, INC. [US/US]; 100 Princeton South Corporate Center, Suite 300, Ewing, NJ (84) Designated States (unless otherwise indicated, for every 08628 (US). kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (72) Inventors; and UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, (71) Applicants : WOTTON, Paul, K. [US/US]; 1 Jefferson TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, Court, Newtown, PA 18940 (US). SADOWSKI, Peter EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, [US/US]; 8974 Pheasant Run Road, Woodbury, MN 553 18 MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (US). KAUSHIK, Dave, J. [US/US]; 250 Phillips Blvd., TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, Suite 290, Ewing, NJ 08618 (US). CAPONE, Dominic, KM, ML, MR, NE, SN, TD, TG). Phillip [US/US]; 2046 Parkview Avenue, Abington, PA 19001 (US). Published: — with international search report (Art. 21(3)) (54) Title: CONSTANT VOLUME PREFILLED SYRINGES AND KITS THEREOF (57) Abstract: The present disclosure relates, in part, to a kit including at least one first prefilled syringe. The first prefilled syringe includes a dose of a hazardous agent in a first volume of a pharmaceutical composition comprising a pharmaceutically acceptable solvent. The dose of the hazardous agent is in a range of from about 7.5 mg to about 25 mg, and the first volume of the pharmaceut - ical composition in the first prefilled syringes is substantially the same as a second volume of the pharmaceutical composition in a second prefilled syringe containing the same hazardous agent, the second prefilled syringe being from the same kit or a different kit. TITLE OF THE INVENTION [0001] Constant Volume Prefilled Syringes and Kits Thereof CROSS REFERENCE TO RELATED APPLICATIONS [0002] This application claims priority of U.S. Provisional Patent Application No. 61/778,398 filed March 12, 2012, which is incorporated by reference herein for all purposes. BACKGROUND OF THE INVENTION [0003] Since the late 1980's hazardous agents, such as cytotoxic agents, have been useful in managing and treating a number of diseases such as rheumatoid arthritis (and other autoimmune diseases), juvenile rheumatoid arthritis, psoriasis, psoriatic arthritis, systemic lupus erythematosus, steroid-resistant polymyositis or dermatomyositis, Wegener's granulomatosis, polyarteritis nodosa, hormonal imbalances, and some forms of vasculitis. Hazardous agents tend to exhibit side effects, however, that are harmful or toxic to the subject. Many of these side effects occur when hazardous agents are administered orally, but the oral form is generally the preferred method of delivery of these agents due to its ease of use. [0004] In addition to increased toxicity, variable and reduced bioavailability has been observed for some hazardous agents, such as methotrexate, that are orally administered. These limitations are particularly demonstrated when the oral dosing is escalated beyond 15 g per week. It has been suggested that with parenteral administration, such as by injection, more predictable, reproducible and complete bioavailability along with better therapeutic results could be achieved, particularly at higher dosages. [0005] Only about 7% of the prescriptions for methotrexate written by rheumatologists are for an injectable formulation. Reasons for prescribing methotrexate injections are usually to improve bioavailability or to alleviate side effects. Physicians have expressed interest in increasing the number of prescriptions for cytotoxic agent injections, and particularly injections for home use and administration by a patient. This is generally not considered feasible because it is not possible to ensure that patients can reliably and repeatably draw an accurate dose from vials and correctly administer the product by subcutaneous (SC) injection, especially with agents used to treat patients suffering from certain debilitating diseases. Additionally, the toxicity of hazardous agents increases the risk that non-users of the injections will come into contact with the cytotoxic agents in a home setting. Insufficient data exists on the effect of low dose, chronic exposure to hazardous agents that are, or may be, candidates for home use or self-injection. In the absence of such information, practice guidelines direct one to assume a high degree risk for injectable hazardous agents such as methotrexate, with the recommendation of formal directives and risk assessments, including formal training and mitigation strategies, to minimize risk (see Oliver, S,, and Livermore, P., Administering subcutaneous methotrexate for inflammatory arthritis: RCN guidance for nurses, 2004; Royal College of Nursing, Wyeth, Publication Code 002 269). Specific directives include: preparation of syringes in dedicated pharmacies with aseptic preparation areas; administration performed in specific locations and only by adequately trained personnel; spillage kits located proximal to use areas; accounting for all who may be at risk in the event of an accident; and audits to assess compliance and execution of risk mitigation strategies. Because of the need for such directives, and thus the large number of precautions that must be learned and followed in order to safely inject a hazardous agent, it is presently thought that it is not practical for hazardous agents, and particularly methotrexate, to be self- injected by a patient outside of a clinical setting or without the assistance of a health care provider. BRIEF SUMMARY OF THE INVENTION [0006] In one aspect, the present invention provides a kit including at least one first prefilled syringe, the first prefilled syringe includes a dose of a hazardous agent in a first volume of a pharmaceutical composition comprising a pharmaceutically acceptable solvent, wherein the dose of the hazardous agent is in a range of from about 7.5 mg to about 25 mg, and wherein the first volume of the pharmaceutical composition in the first prefilled syringes is substantially the same as a second volume of the pharmaceutical composition in a second prefilled syringe containing the same hazardous agent, the second prefilled syringe being from the same kit or a different kit. [0007] In another aspect, the present invention provides a kit comprising at least one first prefilled syringe, the first prefilled syringe including a dose of a hazardous agent in a first volume of a pharmaceutical composition comprising a pharmaceutically acceptable solvent, wherein the dose of the hazardous agent being in a range of from about 50 mg to about 100 mg, and wherein the first volume of the pharmaceutical composition in the first prefilled syringe is substantially the same as a second volume of the pharmaceutical composition in a second prefilled syringe containing the same hazardous agent, the second prefilled syringe being included in the same kit. [0008] In another aspect, the present invention provides a method of treating a patient with a hazardous agent, the method comprising administering to the patient the hazardous agent from the kit, the kit including at least one first prefilled syringe, the first prefilled syringe including a dose of a hazardous agent in a first volume of a pharmaceutical composition comprising a pharmaceutically acceptable solvent, wherein the dose of the hazardous agent being in a range of from about 7.5 mg to about 25 mg, and wherein the first volume of the pharmaceutical composition in the first prefilled syringe is substantially the same as a second volume of the pharmaceutical composition in a second prefilled syringe containing the same hazardous agent, the second prefilled syringe being from the same kit or a different kit. [0009] In another aspect, the present invention provides a method for treatment, the method comprising: (a) selecting a dose level of a hazardous agent for subcutaneous administration to a patient, wherein the selected dose level of the hazardous agent for subcutaneous administration is equivalent to the oral dose of the hazardous agent, (b) subcutaneously administering the hazardous agent to the patient at the selected dose level; (c) evaluating the patient's response to the subcutaneously administered dose level of the hazardous agent; and (d) changing or maintaining the selected dose level of the hazardous agent on the basis of the patient's response in step (c). DETAILED DESCRIPTION OF THE INVENTION A. PREFILLED SYRINGES [0010] In one aspect, the present invention provides a kit including at least one first prefilled syringe and instruction for use.
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