Treatment Of Suicidal Ideation Or Behavior Using Inhibitors Of Nicotinic Acetylcholine Receptors

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(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(19) World Intellectual Property Organization
International Bureau

(43) International Publication Date 2 1 April 2011 (21.04.2011)
(51) International Patent Classification: A61K 31/407 (2006.01) A61P 25/18 (2006.01) A61K 31/55 (2006.01) A61P 25/24 (2006.01) A61K 33/14 (2006.01)

(10) International Publication Number

PCT

WO 2011/047341 A 3
AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.

(21) International Application Number: PCT/US20 10/052949 (22) International Filing Date:
15 October 2010 (15.10.2010)

(84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, English (26) Publication Language: GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, (30) Priority Data: TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, 61/252,343 16 October 2009 (16.10.2009) US EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, ΓΓ , LT, LU, (71) Applicant (for all designated States except US): UNI¬ LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, VERSITY OF SOUTH FLORIDA [US/US]; 3802 SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, Spectrum Blvd., Suite 100, Tampa, FL 33612-9220 (US). GW, ML, MR, NE, SN, TD, TG). (25) Filing Language:

English

(72) Inventors; and (75) Inventors/ Applicants (for US only): SHEEHAN, David, V . [US/US]; 6 1 1 Warren Road, Lutz, FL 33548 (US). SHYTLE, R., Douglas [US/US]; 14784 Sunset Drive, Largo, FL 33774-4810 (US).

Published:

— —

with international search report (Art. 21(3)) before the expiration o the time limit for amending the f claims and to be republished in the event of receipt of amendments (Rule 48.2(h))

(74) Agents: LADWIG, Glenn et al; Saliwanchik, Lloyd & Saliwanchik, P.O. Box 142950, Gainesville, FL (88) Date of publication of the international search report: 18 August 201 1 32614-2950 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM,

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(54) Title: TREATMENT OF SUICIDAL IDEATION OR BEHAVIOR USING INHIBITORS OF NICOTINIC ACETYLCHOLINE RECEPTORS

o

(57) Abstract: The invention concerns methods of treating suicidal ideation or behavior in a subject in need thereof, comprising decreasing endogenous nicotinic acetylcholine receptor (nAChR) activity in the subject; therapeutic packages for treating suicidal ideation or behavior; and methods for determining the efficacy of a treatment for suicidal ideation or behavior. In some em b o di ments, the treatment methods comprise administering t o the subject an effective amount of an inhibitor of a nAChR, such a s a lithium compound, mecamylamine, clozapine, or asenapine.

A.

CLASSIFICATION

O F SUBJECT

MATTER

A61K 31/407(2006.01)i, A61K 31/55(2006.01)1, A61K 33/14(2006.01)1, A61P 25/18(2006.01)1, A61P 25/24(2006.01)1
According to International Patent Classification (IPC) or t o both national classification and IPC
B.

FIELDS SEARCHED

Minimum documentation searched (classification system followed by classification symbols) A61K 31/407; A61K 31/473; A61K 31/474; A61K 31/44; A61K 31/551 Documentation searched other than minimum documentation t o the extent that such documents are included in the fields searched Korean utility models and applications for utility models Japanese utility models and applications for utility models Electronic data base consulted during the international search (name of data base and, where practicable, search terms used) eKOMPASS(KIPO internal), Pubmed, Google & Keywords: nicotinic acetylcholine receptor, iiAChR, suicide, depression, lithium, mecamylamine, asenapine
C.

DOCUMENTS

CONSIDERED

T O B E RELEVANT

Category

Citation of document, with indication, where appropriate, of the relevant passages
WO 2007-100430 A 2 (YALE UNIVERSITY
e t al.) 0 7 September

Relevant to claim No.
39-42,46-47

2007

See page 2 , lines 5-20, page 8 , lines 6-13 and claims 1-62. U S 2006-0211686 See paragraphs U S 2006-0084692 See paragraphs A l (ABBOTT LABORATORIES
[0005],
[0019] and claims
e t al.) 2 1 September
1 , 11.

2006

39-42,46-47

A l (PFIZER INC. e t al.) 20 April 2006 [0004]-[0005] and claim 20. and Suicide Risk in Major Journal o f Clinical Psychyatry,

39-42,46-47

BALDESSARINI , R.J. e t a l . , Lithium Treatment Affective Disorders :Update and New Findings, tables 1-4 and figures 1-2.
2004, Vol.64, pp. 44-52

39-42,46-47

See abstract,

GEORGE, T.P. e t a l . .Nicotinic Antagonist Reuptake Inhibitor-Refractory Psychopharmacology,

Augmentation

o f Selective

Serotonin

39-42,46-47

Major Depressive

Disorder .Journal o f Clinical

June 2008, Vol.29, No. 3 , pp. 340-344
1.

See abstract and figure

Further documents are listed in the continuation of Box C .
* Special categories of cited documents: document defining the general state of the art which i s not considered t o b e of particular relevance "E" earlier application or patent but published on or after the international filing date "L" document which may throw doubts on priority claim(s) or which i s cited t o establish the publication date of citation or other special reason (as specified) "O" document referring t o an oral disclosure, use, exhibition or other means "P" document published prior t o the international filing date but later than the priority date claimed
"A"

patent family annex.
later document published after the international filing date or priority date and not in conflict with the application but cited t o understand the principle or theory underlying the invention document of particular relevance; the claimed invention cannot b e considered novel or cannot b e considered t o involve an inventive step when the document i s taken alone document of particular relevance; the claimed invention cannot b e considered t o involve an inventive step when the document i s combined with one or more other such documents, such combination being obvious t o a person skilled in the art document member of the same patent family

Date of the actual completion of the international search
2 3 JUNE 201 1 (23.06.201 1)

Date of mailing of the international search report

2 3 JUNE 2011 (23.06.2011)
Authorized officer KANG-PIL KIM Telephone No.
82-42-481-8393

Name and mailing address of the ISA/KR
mm

Korean Intellectual Property Office Government Complex-Daej eon, 189 Cheongsa-ro, Seo-gu, Daejeon 302-701, Republic of Korea

Facsimile No. 82-42-472-7140 Form PCT/ISA/210 (second sheet) (July 2009)

Box No. I I

Observations where certain claims were found unsearchable (Continuation o f item 2 o f first sheet)

This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:

1.

Claims Nos.: 1-38, 43-45, 48-58 because they relate to subject matter not required to be searched by this Authority, namely: Claims 1-38, 43-45 and 48-58 pertain t o a method of treatment of the human body by therapy, and thus relate to a subject matter which this International Searching Authority i s not required to search under Article 17(2)(a)(i) of the PCT and Rule 39. 1(iv) of the Regulations under the PCT. Claims Nos.: 8 , 52-53, 55-56, 59-60 because they relate to parts of the international application that do not comply with the prescribed requirements t o such an extent that no meaningful international search can be carried out, specifically:

Claims 8 , 52-53, 55-56 and 59-60 are dependent claims of a multiple dependent claim.

Claims Nos.: 7 , 13-38, 5 1, 54, 57-58 because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
Box No. Ill Observations where unity o f invention is lacking (Continuation o f item 3 o f first sheet)

This International Searching Authority found multiple inventions in this international application, a s follows:

I I A s all required addtional search fees were timely
claims.

paid by the applicant, this international search report covers all searchable

I I A s all searchable claims could be searched without effort justifying
of any additional fee.

an additional fee, this Authority did not invite payment

I I A s only some of the required additional search fees were timely paid by the applicant, this international search report covers
only those claims for which fees were paid, specifically claims Nos.:

4.

I I N o required additional search fees were timely

paid by the applicant. Consequently, this international search report restricted t o the invention first mentioned in the claims; it i s covered by claims Nos.:

Remark o n Protest

|

j I

| The additional search fees were accompanied by the applicant's protest and, where applicable, the payment of a protest fee. j The additional search fees were accompanied by the applicant's protest but the applicable protest fee was not paid within the time limit specified in the invitation. N o protest accompanied the payment of additional search fees.

Form PCT/ISA/210 (continuation of first sheet (2)) (July 2009)

Information on patent family members

PCT/US2010/052949
Patent family member(s) Publication date

Patent document cited in search report

Publication date

O

2007-- 100430 A2

07 , 09 . 2007

E P 19765 9 A2

2009-31849 1 A O 2007- 100430 A3 wo 2007- 100430 A3
US

08 . 10 , 2008 24. 12 , 2009 2 1. 08 , 2008 07 . 09 , 2007 28 . 09 , 2006 12 . 12 , 2007 2 1. 08 , 2008 12 . 10 , 2007 28 . 09 , 2006 25 . 0 1 , 2007 09 . 07 , 2009

us 2006--02 11686

A1

, 2 1 . 09 . 2006

CA

260 1509 A

E P 1863485 A2

J P 2008-533 142 T
MX
WO WO

20070 1436 A 2006- 10 1745 A2 2006- 10 1745 A3 2009- 176855 A

us 2006--0084692

A

20 , 04 . 2006

US

PCT/ISA/210 (patent family annex) (July 2009)



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