Malcolm C Pike

US Patent:

6958142, Oct 25, 2005

Filed:

Nov 15, 2002

Appl. No.:

10/298378

Inventors:

John R. Daniels - Pacific Palisades CA, US
Malcolm C. Pike - Marina Del Rey CA, US
Darcy V. Spicer - La Canada CA, US
AnnaMarie Daniels - Pacific Palisades CA, US

Assignee:

Balance Pharmaceuticals, Inc. - Santa Monica CA

International Classification:

A61K009/12
A61K031/56
A61F002/02

US Classification:

424 45, 424434, 424426, 424239, 514 2, 514 58, 514874

Abstract:

A nasal spray formulation for use in female contraception or in the treatment of benign gynecological disorders is described. The nasal preparation is comprised of a GnRH compound and an estrogenic compound in the form of a water-soluble complex with a water-soluble cyclodextrin. The preparation effectively suppresses ovarian estrogen and progesterone production, and prevents signs and symptoms of estrogen deficiency, without a significant increase in the risk of endometrial hyperplasia.

US Patent:

6960337, Nov 1, 2005

Filed:

Nov 15, 2002

Appl. No.:

10/298851

Inventors:

Anne-Marie Daniels - Pacific Palisades CA, US
John R. Daniels - Pacific Palisades CA, US
Malcolm C. Pike - Marina Del Rey CA, US
Darcy V. Spicer - La Canada CA, US

Assignee:

Balance Pharmaceuticals, Inc. - Santa Monica CA

International Classification:

A61K009/12
A61K031/56
A61F002/02

US Classification:

424 45, 424434, 424426, 424239, 514 2, 514841, 514843, 514874, 514 58

Abstract:

An improvement in a method of treating benign gynecological disorders is described. In the method, treatment of a benign gynecological disorder with a composition comprised of a gonadotropin releasing hormone (GnRH) compound and an estrogenic compound, and optionally, an androgenic compound, is extended to premenopausal women who are not receiving an exogenously supplied progestin on a regular or periodic basis. Treatment in accord with the invention does not increase significantly the risk of endometrial hyperplasia. The method is also suitable for contraception.

US Patent:

7029657, Apr 18, 2006

Filed:

Nov 15, 2002

Appl. No.:

10/295337

Inventors:

Malcolm C. Pike - Marina Del Rey CA, US
Darcy V. Spicer - La Canada CA, US
AnnaMarie Daniels - Pacific Palisades CA, US
John R. Daniels - Pacific Palisades CA, US

Assignee:

Balance Pharmaceuticals, Inc. - Santa Monica CA

International Classification:

A61K 9/12
A61K 9/72

US Classification:

424 45, 424434, 424426, 424239, 514 2, 514841, 514843, 514874

Abstract:

The present invention relates to an improvement in a method of contraception, in treatment of benign gynecological disorders, and in hormone replacement. The improved method includes administering intranasally an estrogenic compound and an androgenic compound, and in some embodiments an optional progestin compound, in a once-daily bolus formulation comprised of the two or three steroids complexed with a cyclodextrin. An intranasal delivery system for administration of the formulation is also described.

US Patent:

20010016578, Aug 23, 2001

Filed:

May 1, 2001

Appl. No.:

09/846626

Inventors:

Darcy Spicer - Pasadena CA, US
Malcolm Pike - Long Beach CA, US
John Daniels - Pacific Palisades CA, US

Assignee:

Balance Pharmaceuticals, Inc.

International Classification:

A61K031/57
A61K031/56

US Classification:

514/171000, 514/519000

Abstract:

Compositions and methods for use in preventing conception or treating benign gynecological disorders, wherein an effective amount of an antiprogestational agent [e.g., progesterone (progestin, progestogen, gestagen) antagonist or progesterone synthesis inhibitor] administered over a first period of time is combined with an effective amount of a progestogen for a second period of time. The antiprogestational agent is selected from single agents or mixtures thereof. The progestogen is selected from single agents or mixtures of natural or synthetic progestogens. The formulations are effective as contraceptive agents and for treatment of benign gynecological disorders including uterine fibroids, premenstrual syndrome, dysfunctional uterine bleeding, polycystic ovarian syndrome and endometriosis.

US Patent:

20060008420, Jan 12, 2006

Filed:

Sep 9, 2005

Appl. No.:

11/223531

Inventors:

John Daniels - Pacific Palisades CA, US
Malcolm Pike - Marina Del Rey CA, US
Darcy Spicer - La Canada CA, US
AnnaMarie Daniels - Pacific Palisades CA, US

International Classification:

A61L 9/04

US Classification:

424045000

Abstract:

A nasal spray formulation for use in female contraception or in the treatment of benign gynecological disorders is described. The nasal preparation is comprised of a GnRH compound and an estrogenic compound in the form of a water-soluble complex with a water-soluble cyclodextrin. The preparation effectively suppresses ovarian estrogen and progesterone production, and prevents signs and symptoms of estrogen deficiency, without a significant increase in the risk of endometrial hyperplasia.

US Patent:

20060013776, Jan 19, 2006

Filed:

Sep 9, 2005

Appl. No.:

11/223661

Inventors:

Anna-Marie Daniels - Pacific Palisades CA, US
John Daniels - Pacific Palisades CA, US
Malcolm Pike - Marina Del Rey CA, US
Darcy Spicer - La Canada CA, US

International Classification:

A61K 38/09
A61K 31/56
A61K 31/724
A61L 9/04

US Classification:

424045000, 514015000, 514171000, 514058000

Abstract:

An improvement in a method of treating benign gynecological disorders is described. In the method, treatment of a benign gynecological disorder with a composition comprised of a gonadotropin releasing hormone (GnRH) compound and an estrogenic compound, and optionally, an androgenic compound, is extended to premenopausal women who are not receiving an exogenously supplied progestin on a regular or periodic basis. Treatment in accord with the invention does not increase significantly the risk of endometrial hyperplasia. The method is also suitable for contraception.

US Patent:

20060147385, Jul 6, 2006

Filed:

Mar 3, 2006

Appl. No.:

11/367910

Inventors:

Malcolm Pike - Marina Del Rey CA, US
Darcy Spicer - La Canada CA, US
AnnaMarie Daniels - Pacific Palisades CA, US
John Daniels - Pacific Palisades CA, US

International Classification:

A61K 31/724
A61L 9/04
A61K 31/56

US Classification:

424045000, 514058000, 514170000

Abstract:

The present invention relates to an improvement in a method of contraception, in treatment of benign gynecological disorders, and in hormone replacement. The improved method includes administering intranasally an estrogenic compound and an androgenic compound, and in some embodiments an optional progestin compound, in a once-daily bolus formulation comprised of the two or three steroids complexed with a cyclodextrin. An intranasal delivery system for administration of the formulation is also described.

US Patent:

62252984, May 1, 2001

Filed:

Jun 18, 1997

Appl. No.:

8/878690

Inventors:

Darcy V. Spicer - Pasadena CA
Malcolm Cecil Pike - Long Beach CA
John R. Daniels - Pacific Palisades CA

Assignee:

Balance Pharmaceuticals, Inc. - Pacific Palisades CA

International Classification:

A61K 3156

US Classification:

514170

Abstract:

Compositions and methods for use in preventing conception or treating benign gynecological disorders, wherein an effective amount of an antiprogestational agent [e. g. , progesterone (progestin, progestogen, gestagen) antagonist or progesterone synthesis inhibitor] administered over a first period of time is combined with an effective amount of a progestogen for a second period of time. The antiprogestational agent is selected from single agents or mixtures thereof. The progestogen is selected from single agents or mixtures of natural or synthetic progestogens. The formulations are effective as contraceptive agents and for treatment of benign gynecological disorders including uterine fibroids, premenstrual syndrome, dysfunctional uterine bleeding, polycystic ovarian syndrome and endometriosis.