In the Journal of American Medical Association in 1999 article, sexual problems are common in women and men. In a survey of men and women aged 18 – 59 years, about 43 percent of women and 31 percent of men reported some sexual problem. According to Sexual Function Health Council of the American Foundation of Urological Diseases (2006) in the United States, estimated about 30 million men have some form of erectile dysfunction (ED) or sometimes called impotence. Experiencing the inability to get or achieve sexual achievement of satisfaction does vary from chronic, partial or brief episodes. In older men the problem associated to ED usually is physically related to disease, injury or side of effects of medication.
Also, erectile dysfunction has been linked to emotional stress, such as the loss of a partner and depression. Statistically, about five percent of men in their forties and fifteen to twenty-five percent of sixty-five year old men experience erectile dysfunction. In some cases, erectile dysfunction causes emotional and relationship problems and has lead to diminished self-esteem. In 1999, according to the National Ambulatory Medical Survey, approximately 22 out of 1000 men in the United States received medical attention for erectile dysfunction. Female sexual dysfunction is caused by hormonal imbalance, such a decrease in estrogen following menopause or related to a medical condition (Including having pain during intercourse, linked to a variety of medical problems). Also, depression or emotional stress can be linked to a lack of sexual desire or achievement of sexual fulfillment. The problem can cause stress and have a negative impact in a relationship.
Medication is available to treat erectile dysfunction, including popular and advertised Viagra, Levitra and Cialis. All of these medications are classified as Phosphodiesterase – 5 inhibitors (PDE – 5 Inhibitors), taken at least one hour before planning to have sexual activity. About eighty-three percent of men taking any one of these PDE – 5 inhibitors, erectile dysfunction had been cured. However, according to the Food and Drug Administration, reported cases taking PDE – 5 inhibitors experienced varies degrees of vision loss or in some cases irreversible vision loss. Those taking nitrates such as nitroglycerin should not take a PDE – 5 Inhibitor. The combination could dangerously lower blood pressure and lead to a stroke, heart attack or death. Statistically, one half of all patients initially prescribed a PDE – 5 Inhibitor did not renew their prescription due to adverse side effects, problems associated taking other medications and / or not achieving desired results.
Palatin Technologies, a bio-pharmaceutical firm based in Cranbury, developed a drug called Bremelanotide (BMT), partnership with King Pharmaceuticals (both companies are publicly traded) treating sexual dysfunction and packaged as a nasal spray. Bremelanotide is a synthetic aphrodisiac, colorless, odorless, and tasteless substance. Also, first compound in a new drug class called melanocortin receptor agonists. The Clinical trials both companies jointly undertook (May 2006) to ascertain safety and efficacious doses, evaluating Bremelanotide. Originally, bremelanotide was sold as peptide Melantan (one and two) as a sunless tanning agent. Noticeable side effect, in most men increased sexual arousal and spontaneous erections. Including in the clinical trail study patients that are diabetic and non – diabetic. Phosphodiesterase – 5 inhibitors target the vascular system (transport blood through the body), however bremelanotide acts on the pathway that controls sexual function, seems to provide better treatment.
During clinical trials of BMT a single dose has shown to spark arousal within 10 to 45 minutes. Upon administering the nasal spray of BMT, both men and females experienced positive sexual improvement. Additional study tests have been performed on pre-menopausal women with sexual arousal disorder. Two – thirds of them, experienced increase sex drive after taking BMT and, being stimulated watching an adult movie. After clinical trial results have been submitted, some time during the second half of 2006, both companies will seek Food and Drug Administration approval for a large – scale home drug study. Chief Executive Officer and President Carl Spana of Palatin Technologies anticipates Bremelanotide nasal spray will be made available for sale sometime between 2009 to early 2010, and will be first marketed to men. Also, expects the price for the drug to cost between eleven to twelve dollars a dose. The estimated value of sexual pharmaceutical market is $3.8 billion, and estimated to increase $6.6 billion by 2012.
Previously, pharmaceutical companies have failed to provide medication to treat female sexual dysfunction. Pfizer pharmaceutical company unsuccessfully tried Viagra on women and Proctor and Gamble pharmaceutical Intrinsa, failed to gain FDA approval for a testosterone patch shown in studies to increase a women’s libido (The FDA advisory committee required Proctor and Gamble to conduct more tests to find out what are the long term side effects – December 2004). A published study in the Journal of Sexual Medicine July edition, reported women within a day taking BMT had a “sexual encounter” and said the sex was a good as, if not better than, before they began experiencing arousal problems. Most had initiated the sex with their partner.