Be the First

A new erectile dysfunction drug? Treatment for premature ejaculation? Safe, effective testosterone replacement therapy? YES! There are exciting new approaches on the horizon for treatment of these problems. The FDA has approved some of these new drugs, while others are beginning clinical field trials and being given patent approval. Here is a status report and you can discuss these with your care provider.

Testosterone Replacement Therapy

United Pharmaceuticals Incorporated (UniMed), a subsidiary of Solvay Pharmaceuticals, was recently approved by the Food and Drug Administration for the first topical gel for testosterone/androgen replacement. Approximately 4 to 5 million Americans and 2 percent to 16 percent of all erectile dysfunction patients have low levels of male hormones. Until recently injections every two to three weeks or daily patch therapy with a 33 percent irritation level have been the only acceptable safe and effective therapies. Oral drugs are contraindicated for chronic use due to their liver toxicity.

The FDA has approved UniMed's effective, safe, convenient, nonirritating 1 percent testosterone gel, Androgel. This skin gel is only indicated in men with testosterone deficiencies with symptoms including erectile dysfunction, muscle weakness, osteoporosis, vasomotor instability including hot flashes, and depression due to androgen deficiency. Androgel is a clear, colorless gel that is applied once daily to the shoulders, upper arms, or abdomen, and dries within a few minutes. During that time the skin absorbs the testosterone and acts as a reservoir for the hormone which slowly enters the blood stream over the course of the next 24 hours. Normal male hormone levels are restored and symptoms are can be relieved.

The drug is not indicated for women, and pregnant women should certainly avoid contact that may cause significant harm to the fetus. Residual testosterone can be removed with soap and water. Testosterone should not be used to improve athletic performance. Patients interested in getting further information can do so online at www.unimed.com, or call toll free 1-877-463-7645.

Bayer's New Erectile Dysfunction Drug

Since ViagraTM's introduction the diagnosis and treatment of erectile dysfunction in men has been revolutionized. ViagraTM (Sildenafil) falls into a class of drugs called type V phosphodiesterase inhibitors. Type V is basically localized to the pelvic area whereas types I, II, III and IV are located in the eye, heart, blood supply, and gastroesophageal junction. The major side effects of ViagraTM include facial flushing, headaches, stomach upset, and a bright vision with a blue-green halo. All of these are the results of the nonspecific aspects of Sildenafil, i.e. it doesn't just affect type V, it affects type I, III and VI involving the eyes, the stomach, and the blood vessels.

Now Bayer Pharmaceuticals has just developed a new, more specific type V phosphodiesterase inhibitor called Vardenafil, which appears to be more potent than ViagraTM and a lower dosage may produce the same result. It has not been established yet whether it will work on patients that do not respond to ViagraTM. Because it is more specific and involves, for all practical purposes, only type V inhibitors, this drug can have fewer side effects.

At this time there are major phase III clinical trials to determine Vardenafil's safety, dosage, and effectiveness. Over the next one to two years trial results will be completed.

An New Cream For Premature Ejaculation

Premature ejaculation, or the uncontrollable ejaculation immediately after vaginal penetration, causing dissatisfaction in the sexual life of both the man and his partner, probably represents a 20 to 30 percent prevalence among men. Psychiatric counseling and behavioral therapy using the start-stop or squeeze techniques have been reported to be successful in 60 to 95 percent of the patients, but the remission rate is quite high. Patients with premature ejaculation have a heightened sensory response to stimulation in the genital region, and the inability to maintain a sympathetic dampening response as occurs in most men with an erect penis.

Medical therapies for premature ejaculation include topical anesthetics, serotonin re-uptake inhibitors (including Prozac, Zoloft, and Anafranil), sympathetic alpha blockade, and in extreme cases the use of injection therapy with Prostaglandin E-1 to maintain an erection beyond ejaculation for partner satisfaction.

These therapies are reported to be effective in 30 to 70 percent of the patients, but in some situations the side effects make then difficult to use. A new cream called SS Cream is a topical agent developed in Korea from the extract of nine natural products: Ginseng, Angelicae Gigantic Radix, Cistancis Herba, Zanthoxylli Fructs, Torlidis Semen, Asiasara Radix, Catyophylli Flos, Cinnamoni Cortex, and Bufonis Veneum. The cream appears to desensitize the penis and allows for longer, more satisfactory sexual performance.

In a recent study on 55 patients published in the Journal of Urology, approximately 80 percent had a positive effect, whereas fewer than 20 percent were affected by the placebo control cream. Mild, transient local side effects including penile warmth; burning and irritation occurred in fewer than 18 percent of the 530 trials in these patients. Interestingly, four of the patients reported delayed ejaculation of more than 45 minutes. SS Cream may soon be added to our armamentarium of already effective treatments for premature ejaculation.

Vivus Patent for Treatment of Premature Ejaculation

Vivus Incorporated recently announced that the U.S. Patent Office has awarded the company a patent for the administration of 5-HT.Sub.3 receptor antagonist to treat premature ejaculation. This patent provides Vivus with broad protection for the oral administration of this serotonin antagonist, specifically 5-HT3 agonist. The patent also allows administering this 5-HT3 agonist topically (as a cream), transdermally (with a skin patch), or transurethrally (directly through the penis).

In addition, Vivus has announced it will begin phase-2 studies in the United States and Europe with Alista trademark, of a proprietary topical formulation for the treatment of female sexual dysfunction. In December of 1999, Vivus filed a new drug application with the FDA for its second-generation erectile dysfunction drug Alibra, which is an intraurethral pellet containing Prostaglandin E-1 and the alpha I blocker Prazosin.