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US 2016.005 1466A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0051466A1 FARR et al. (43) Pub. Date: Feb. 25, 2016 (54) NOVEL FORMULATIONS FORTREATMENT Publication Classification OF MIGRAINE (51) Int. Cl. 71) Applipplicant: ZOGENIX,9 INC.... E.EmeryV1lle, ille, CA (US A619/00 2006.O1 A613 L/478 (2006.01) (72) Inventors: Stephen J. FARR, Orinda, CA (US); A613 L/4045 (2006.01) John TURANIN, Danville, CA (US); (52) U.S. Cl. Roger HAWLEY, Rancho Santa Fe, CA CPC ........... A61 K9/0019 (2013.01); A61 K3I/4045 SS Jeffrey A. Schuster, Bolinas, CA (2013.01); A61 K31/4178 (2013.01) (57) ABSTRACT (21) Appl. No.: 14/930,982 Systems and methods are described for treating un-met medi (22) Filed: Nov. 3, 2015 cal needs in migraine and related conditions such as cluster headache. Included are treatments that are both rapid onset Related U.S. Application Data and long acting, which include Sustained release formula tions, and combination products. Also included are treat (60) Continuationonunuation oIof application No. 13/863,686,oso, filedIlled on ments ford multiplecombination symptoms products. of migraine, Also included especially head Apr.of 16, 2013, which is a division220 of application No. acheh andd nausea andd Vomiting. Systems thath are se1f filed as -application - - - No. PCT/US2009/002533• 1s s on Apr.s contained, portable, prefilled, and simple to self administer at 24, 2009 the onset of a migraine attack a disclosed, and preferably s include a needle-free injector and a high Viscosity formula (60) Provisional application No. 61/048.463, filed on Apr. tion, to eliminate Such issues as fear of self administration 28, 2008. with needles, and needle Stick and cross contamination. Patent Application Publication Feb. 25, 2016 Sheet 1 of 3 US 2016/0051466 A1 -- J ----. Imigran Time (Hours post-dose) FIG. 1 Sumatriptan 6 mg (injected) 200 md (oral Clinical efficacy (at 2 hrs) 83% 68% Pharmacokinetic parameters: Cmax (ng/ml) 52 95 e AUC(ng/h/ml) 82 413 Ta (min) 13 75 FIG 2 Patent Application Publication Feb. 25, 2016 Sheet 2 of 3 US 2016/0051466 A1 Analgesic Efficacy and Speed of Onset T vs. efficacy with oral migraine drugs (package insert data) 90 80 Eff 7O NZaizatriptan (% enders Zolmitriptan p < 0.02 at 2 hours) 6O Sumatriptan r = -0.98 naratriptan 50 4O Tmax (hrs) Effect of Viscosity on injection time - Needle vs. Intraject 1 hour Intraject 1.OE+O6 O Needle 1.OE+05 1 O E -- O 4 1.OE+03 1.OE+02 1.OE+01 1 5 10 20 50 100 500 1000 12,500 30,000 Viscosity (centipoise) SecondsO.2 FIG. 4 Patent Application Publication Feb. 25, 2016 Sheet 3 of 3 US 2016/0051466 A1 DrugS Subjects Efficacy Haloperidol 6 100% Chlorpromazine 213 93% Droperidol 35 91% Prochlorperazine 64 86% Methotrimeperazine 29 82% FIG. 5 US 2016/005 1466 A1 Feb. 25, 2016 NOVEL FORMULATIONS FOR TREATMENT for 18 months while taking sildenafil citrate 3 or 4 times OF MIGRAINE weekly, wherein the migraines returned when the treatment was ceased. Zonisamide has been studied for and used as a CROSS-REFERENCES migraine preventative medication 0001. This application is a 371 National Phase of PCT/ 0007. Many acute, abortive treatments are used in the US2009/002533 filed Apr. 24, 2009 which application claims treatment of migraine. the benefit of U.S. Provisional Application No. 61/048,463, 0008 Selective serotonin receptor agonists known as filed Apr. 28, 2008 which applications are incorporated herein “triptans' are widely prescribed, and include Sumatriptan, by reference. almotriptan, eletriptan, froVatriptan, naratriptan, rizatriptan, donitriptan and Zomitriptan. Different triptans have varying FIELD OF THE INVENTION pharmacokinetic parameters. Sumatriptan has a half life of 2.5 hours, rizatriptan has a half life of 2-3 hours, naratriptan 0002 The present invention relates to novel formulations has a half life of 5-8 hours, Zolmitriptan has a half life of 3 for treatment of migraine and cluster headache. Various hours, eletriptan has a half life of 4 hours, almotriptan has a classes of formulations including novel combinations and half life of 3-4 hours, and froVatriptan has a half life of 26 sustained release formulations are listed. Preferably these hours. formulations are applicable to needle-free delivery. 0009 Prior to the introduction of triptans and 1991, ergopeptines, including ergotamine, methysergide, and dihy BACKGROUND OF THE INVENTION droergotamine were the standard of care for oral drugs. 0003 Migraine is a debilitating neurological disease that NSAIDs including aspirin, ibuprofen, naproxen, and causes numerous acute symptoms, including headache, nau acetaminophen are available over the counter, while other sea, vomiting, and a heightened sensitivity to brightlights and NSAIDS including diclofenac, flurbiprofen, meclofenamate, noise. Untreated, attacks last from several hours to a few days. isometheptene and indomethacin are available by prescrip Approximately /3 of Suffers experience aura, the perception tion. Opioid analgesics include codeine, morphine, hydroc of strange light or Smell at the onset of an attack. odone, acetyldihydrocodeine, oxycodone, oxymorphone, 0004 Susceptibility to migraine is widespread, with 18% papaverine, fentanyl, alfentanil, Sufentanil, remifentanyl, and of women and 6% of men report having had at least one tramadol. Phenothiazines, including prochlorperazine, have migraine episode in the previous year Lancet 2004:363:381 been used to treat nausea and Vertigo, and are being developed 391, and it will affect 12-28% of people during their life to treat migraine pain. Cox-2 inhibitors include celecoxib times. Eur J Neurol 2006; 13:333-45). The highest rates are (CelebrexR), rofecoxib (Vioxx(R), meloxicam, piroxicam, found in women, between puberty and menopause. Studies in JTE-522 (Japan Tobacco, inc.), L-745,337, NS398, dera twins have shown a genetic component of migraine Suscep coxib, Valdecoxib, Ilumiracoxib, etoricoxib, parecoxib. 4-(4- tibility, and it is twice as prevalent in the families of epilepsy cyclohexyl-2-methyloxazol-5-yl)-2 fluorobenzenesulfona sufferers Ottman, R and Lipton, R. Neurology, 1994. mide, 2-(3,5-difluorophenyl)-3-(4-(methylsulfonyl)phenyl)- Migraine's annual direct medical costs exceed $1 billion, and 2 cyclopenten-1-one, N-2-(cyclohexyloxy)-4-nitrophenyl the yearly cost to employers is approximately S13 billion. methanesulfonamide, 2-(3.4 difluorophenyl)-4-(3-hydroxy 0005. Many drug and non-drug treatments are used for 3-methylbutoxy)-5-4-(methylsulfonyl)phenyl-3(2H) migraine. Non drug treatments include cold or hot shower, pyridaZinone, 2-(2,4-dichloro-6-methylphenyl)amino-5- resting in a dark, silent room, coffee, massage or physical ethyl-benzeneacetic acid, (3Z) 3-(4-chlorophenyl) 4 therapy, acupuncture, acupressure, biofeedback, self-hypno (methylsulfonyl)phenyl)methylenedihydro-2(3H)- sis, herbal remedies, and diet. Recent data have Suggested a furanone, and (S)-6,8-dichloro-2-(trifluoromethyl)-2H-1- possible correlation between patent foramen ovale (PFO) and benzopyran-3-carboxylic acid. Barbiturates can be used, migraine with aura (Headache, October 2007), and studies including amobarbital, butalbital, cyclobarbital, pentobar are underway to determine if surgically closing PFO has any bital, allobarbital, methylphenobarbital, phenobarbital, seco impact on migraine. barbital, and vinylbital. Ion channel modulators, particularly 0006 Preventative drug treatments that have been used calcium channel blockers (Verapamil, Diltiazem, Nifedipine) include low dose aspirin, beta blockers, antihistamines (in or Sodium or potassium channel modulators, may be useful in cluding pizotifen) anticonvulsants (including divalproex), the treatment of migraine. EP0754453B1 discloses the topi monoamine oxidase inhibitors (MAOIs, including phe cal use of local anesthetics, including lidocaine, tetracaine, helzine, isocarboxazid), antidepressants for exampletricyclic prilocaine, bupivicaine, mepivacaine, etidocaine, procaine antidepressants (TCAS, including amitriptyline, nortrip and benzocaine. Monoamine oxidase inhibitors (MAOIs) tyline, doxepin, and protriptyline) selective serotonin may be used, including phehelzine and isocarboxazid. Other reuptake inhibitors (SSRIs), methysergide (although it has useful drugs include dichloralphenaZone, nimopidine, Sub been withdrawn from the US market due to side effects), and stance Pantagonists, capsaicin receptor agonists, botulinum memantine. Beta blockers include but are not limited to non toxin, captopril, tioSpirone, or steroids. For any of these com selective agents (Alprenolol, Carteolol, Levobunolol, Mepin pounds variants including but not limited to an isomer, a dolol, Metipranolol, Nadolol, Oxprenolol, Penbutolol, Pin pharmaceutically acceptable salt, ester, or prodrug thereof dolol, Propranolol, Sotalol, Timolol) B1-Selective agents also may be used. (Acebutolol, Atenolol, Betaxolol, Bisoprolol, Esmolol, 0010 Combinations products have been used, including Metoprolol, Nebivolol) Mixed C.1/B-adrenergic antagonists combinations of aspirin, acetaminophen, and caffeine (Carvedilol, Celiprolol, Labetalol) and B2-Selective agents (ExedrinTM, Novartis), caffeine and ergotamine (Migerot'TM, (Butaxamine). WO0219213 A2 discloses use of PDE-5 G and W Labs), butalbital, acetaminophen and caffeine inhibitors for treatment of prevention of migraine, including (FioricetTM, Watson Pharmaceuticals, also available in com an example where a human migraine Suffer is migraine free bination with Codeine, and EsgicTM, Mikart), butalbital, aspi US 2016/005
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