Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2002-01-08
2004-10-26
Tate, Christopher R. (Department: 1654)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C424S725000, C424S737000, C424S739000
Reexamination Certificate
active
06809079
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to compositions and methods for the local administration of a therapeutic preparation for treating female sexual arousal dysfunction, and more particularly, to a preparation comprising calcitonin gene-related peptide conjugated to a hydrophobic agent and methods of use for promoting blood flow to the genital region, specifically the clitoris of a female patient.
2. Description of the State of Art
According to the Journal of the American Medical Association, more than 43% of American women (about 40 million) experience some form of sexual disorder. Other reports state that 70% of post-menopausal and 25% of pre-menopausal women experience sexual dysfunction. Any woman can experience Female Sexual Dysfunction at some point in her life. Physicians and other healthcare providers recognize Female Sexual Dysfunction as a medical condition. It includes a variety of disorders that are related to the desire for sex, arousal during sexual activity, problems with orgasm or pain during sexual activity. If a woman's sexual concerns are recurring in nature and cause her personal distress, she may indeed have female sexual dysfunction.
Specifically, Female Sexual Dysfunction is divided into categories related to desire, orgasm, arousal and pain.
Disorders of Sexual Arousal
It is believed that the difficulty or inability to achieve clitoral tumescence may be related to and associated with other symptoms of female sexual arousal disorder. According to the International Consensus Report on Female Sexual Dysfunction, Female Sexual Arousal Disorder (FSAD) is defined as the persistent or recurrent inability to attain or maintain adequate genital lubrication or swelling responses. FSAD may be expressed as a lack of subjective excitement or lack of genital (lubrication/swelling) or other somatic responses (AFUD Consensus Report of FSD, 1998). Reduced sexual arousal may result in discomfort or even pain due to insufficient vaginal lubrication and/or a lack of physical preparation of the genitalia for sexual activity. Although female sexual arousal disorder is often a change from a previous state of arousability, in some cases it is a lifelong condition.
The clitoris in the human female consists of a cylindrical, erectile organ composed of three parts: The outermost glans or head, the middle corpus or body, and the innermost crura. The glans of the clitoris is visualized as it emerges from the labia minora, which bifurcates to form the upper prepuce anteriorly and the lower frenulum posteriorly. The body of the clitoris consists of two paired corpora cavernosa of about 2.5 cm in length. The body extends under the skin at the corona to the crura. The two crura of the clitoris, formed from the separation of the most proximal portions of the corpora in the perineum, attach bilaterally to the undersurface of the symphysis pubis at the ischiopubic rami.
A fibrous tunica albuginea enseathes each corporal body made up of lacunar space sinusoids surrounded by trabecula of the vascular smooth muscle and collagen connective tissue. No retractor clitoridis muscle exists in humans as it does in other animals such as cattle and sheep, however a supporting suspensory ligament does hold the clitoris in the introital region.
The main arterial supply to the clitoris is from the ilio-hypogastric-pudendal arterial bed. The internal pudendal artery is the last anterior branch off the internal iliac artery. Distally, the internal pudendal artery traverses Alcock's canal, then terminates as it supplies the inferior rectal and perineal artery which supply the labia. The common clitoral artery continues to the clitoris. This artery bifurcates into a dorsal clitoral artery and a cavernosal clitoral artery.
In the normal female, autonomic efferent innervation of the clitoris passes from the pelvic and hypogastric nerves to the clitoris. Pelvic nerve stimulation results in clitoral smooth muscle relaxation in an increase in clitoral cavernosal artery inflow and an increase in clitoral intracavernous pressure, which lead to tumescence and extrusion of the glans clitoris.
Clitoral erectile insufficiency or reduced clitoral arterial flow may be caused by cardiac insufficiency, atherosclerosis, medication, diabetes mellitus, smoking, certain sexually transmitted diseases, nerve damage may have a negative effect on physiological, or age-related causes, among other factors. Women who are breastfeeding often report a reduction in vaginal lubrication. Reduced levels of estrogen during and after menopause also contributes to arousal difficulties as well.
Reduced clitoral arterial flow may lead to fibrosis of the clitoral cavernosa and reduced clitoral physiological function. In an animal model, Park, et al., demonstrated that significant collagen build up occurs when the arterial inflow to the clitoris is compromised. This work demonstrated the importance of maintaining arterial flow to the clitoris to prevent collagen build up and fibrosis of the smooth muscle. See Park, K., et al., “Vasculogenic Female Sexual Dysfunction: The Hemodynamic Basis for Vaginal Engorgement Insufficiency and Clitoral Erectile Insufficiency,”
IJIR,
9:27-37 (1997).
Certain medication can also interfere with arousal. Antidepressants, antihypertensives, and antihistamine medications are commonly associated with adverse sexual side effects. The direct physiological effects of these drugs interfere with the processes involved in sexual excitement.
Treatments to Enhance Sexual Arousal in Women
Most of the treatments for sexual arousal disorders are still in the experimental stages, although a variety of products are being evaluated for their effectiveness in increasing blood flow to the genitalia and facilitating lubrication. Several vasodilator creams are being tested to measure their ability to improve sexual arousal. These creams work by expanding the arteries to increase blood flow to genital tissue. A number of oral medications are being investigated as well, including Viagra and related drugs, “natural” supplements such as DHEA and yohimbine, dopamine agonists, and drugs that stimulate the sympathetic nervous system. These drugs work by promoting blood flow, stimulating certain components of the nervous system, or a combination of both. Because most of these studies are fairly recent (or ongoing), there is not yet an FDA-approved medication for female sexual arousal disorder.
The FDA recently approved a new non-pharmaceutical product to aid sexual arousal in women. EROS-CVD is a small device that creates a gentle suction over the clitoris in order to increase blood flow and sensation. It is available only by prescription.
Until recently, most vasculogenic sexual-dysfunction research has focussed on males, e.g., on physiologic causes of erectile insufficiency. Abnormal reduction of blood flow through the penile cavernosal arteries and excess venous outflow, i.e., veno-occlusive dysfunction, are well-recognized physiologic causes of impotence and have been the subject of intense study. Now, however, an increasing amount of research is being conducted in the field of vasculogenic female sexual dysfunction.
Studies of sexual dysfunction in couples have revealed that more females than males may experience arousal or orgasmic problems. Whereas 40% of men experienced erectile or ejaculatory dysfunction in one such study, arousal or orgasmic dysfunctions affected 63% of women. See Frank, E., et al., “Frequency of sexual dysfunction in ‘normal’ couples,”
N. Engl. J. Med.,
299:111-115 (1978), which is incorporated herein by reference. Vasculogenic factors are thought to be one of the primary causes of female sexual dysfunction, and increasing age and the onset of menopause contribute to the problem.
It is known that during normal sexual function, the female undergoes many physiological changes. These changes include, among others, increased labial flow, dilation of the introitus, changes in vaginal-wall blood flow (resulting in color change, for example), vaginal lubricati
Rosenthal Gary J.
Southard Jeffrey L.
Yewey Gerald L.
Audet Maury
Morrison & Foerster / LLP
Tate Christopher R.
VasoGenix Pharmaceuticals, Inc.
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