Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-10-12
2002-10-29
Wilson, James O. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S459000, C514S517000
Reexamination Certificate
active
06472370
ABSTRACT:
BACKGROUND OF THE INVENTION
Compounds of Formula 1:
are structurally novel aantiepileptic compounds that are highly effective anticonvulsants in animal tests (Maryanoff, B. E, Nortey, S. O., Gardocki, J. F., Shank, R. P. and Dodgson, S. P.
J Med. Chem
. 30, 880-887, 1987; Maryanoff, B. E., Costanzo, M. J., Shank, R. P., Schupsky, J. J., Ortegon, M. E., and Vaught J. L. Bioorganic & Medicinal Chemistry Letters 3, 2653-2656, 1993). These compounds are covered by U.S. Pat. No. 4,513,006. One of these compounds 2,3:4,5-bis-O-(1-methylethylidene)-&bgr;-D-fructopyranose sulfamate known as topiramate has been demonstrated in clinical trials of human epilepsy to be effective as adjunctive therapy or as monotherapy in treating simple and complex partial seizures and secondarily generalized seizures (E. FAUGHT, B. J. WILDER, R. E. RAMSEY, R. A. REIFE, L. D. KRAMER, G. W. PLEDGER, R. M. KARIM et. al., Epilepsia 36 (S4) 33, 1995; S. K. SACHDEO, R. C. SACHDEO, R. A. REIFE, P. LIM and G. PLEDGER, Epilepsia 36 (S4) 33, 1995), and is currently marketed for the treatment of simple and complex partial seizure epilepsy with or without secondary generalized seizures in approximately twenty countries including the United States, and applications for regulatory approval are presently pending in several additional countries throughout the world.
Compounds of Formula I were initially found to possess anticonvulsant activity in the traditional maximal electroshock seizure (MES) test in mice (SHANK, R. P., GARDOCKI, J. F., VAUGHT, J. L., DAVIS, C. B., SCHUPSKY, J. J., RAFFA, R. B., DODGSON, S. J., NORTEY, S. O., and MARYANOFF, B. E., Epilepsia 35 450-460, 1994). Subsequent studies revealed that Compounds of Formula I were also highly effective in the MES test in rats. More recently topiramate was found to effectively block seizures in several rodent models of epilepsy (J. NAKAM , S. TAMURA, T. KANDA, A. ISHII, K. ISHIHARA, T. SERIKAWA, J. YAMADA, and M. SASA, Eur. J. Pharmacol. 254 83-89, 1994), and in an animal model of kindled epilepsy (A. WAUQUIER and S. ZHOU, Epilepsy Res. 24, 73-77, 1996).
Preclinical studies on topiramate have revealed previously unrecognized pharmacological properties which suggest that topiramate will be effective in treating post traumatic stress disorder.
DISCLOSURE OF THE INVENTION
Accordingly, it has been found that compounds of the following formula I:
wherein X is O or CH
2
, and R1, R2, R3, R4 and R5 are as defined hereinafter are useful in treating alcohol addiction and abuse.
REFERENCES:
patent: 4513006 (1985-04-01), Maryanoff et al.
patent: WO 98 00123 (1998-08-01), None
Wauquier, A. et al “Topiramate: a potent anticonvulsant in the amygdala-kindled rat” Epilepsy Res. vol. 24, pp. 73-77, 1996.*
Keck, P. et al “Valproate and carbamazepine in the treatment of panic and post traumatic stress disorders, withdrawal states . . . ”J. Clin. Psychopharm., vol. 12, No. 1, pp. 36S-41S, 1992.*
Viola J. et al.: “Pharmacological Management of post-traumatic stress disorder: clinical study Of 5-year retrospective study, 1990-5”, Military Medicine (Sep. 1997) 162 (9) 515-9.
Friedman, M.J.: “Drug treatment for PTSD. Answers and Questions.” Annals of the N.Y. Academy of Sciences (Jun. 21, 1997) 821; 359-71, Ref. 50.
Davidson J. R.: “Biological therapies for Post-Traumatic Stress Disorder; an Overview.” J. of Clin. Psychiatry (1997) 58 supp. 9 29-32, Ref. 20.
Hamada K. et al.: “Therapeutic & Prophylactic effects of antiepileptic drugs in Kindling Model” Recent Advances in Clin. Neurophysiology, Jan. 1, 1996, pp 826-831, table 1.
Fesler F A: “VALPROATE IN Combat-Related Postraumatic Stress Disorder” Journal of Clinical Psychiatry, vol. 52, No. 9, 1991, pp. 361-364 XP000914362.
Maier Leigh C.
Ortho-McNeil Pharmaceutical , Inc.
Wilson James O.
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