NEXMED REPORTS POSITIVE RESULTS FOR EARLY EJACULATION PRODUCT.NexMed, Inc. (Nasdaq: NEXM), Robbinsville, NJ, a developer of innovative treatments based on the NexACT(r) drug delivery technology, has reported positive results from an international pilot study for NM100061, NexMed's proprietary product being developed as a treatment for Early Ejaculation ejaculation /ejac·u·la·tion/ (e-jak?u-la´shun) forcible, sudden expulsion; especially expulsion of semen from the male urethra. ("EE"). The 3-month multi-center study was double-blind, placebo controlled and included a total of 89 patients. The patients in this study averaged 43 years of age and were diagnosed with EE for 2.6 years. The primary endpoint for this trial was drug efficacy, as measured by simultaneously extending the ejaculatory e·jac·u·la·to·ry adj. Relating to an ejaculation. latency time to over 2 minutes and improving the patients' overall sexual satisfaction ratio by a minimum of 20%. The results of the study indicate that the primary endpoint was achieved, with a satisfaction rate for patients using the product being 84.8%, versus 23.3% in the placebo group (P<0.001 compared to placebo). The adverse events reported were local, mild and transient, and importantly, none of the enrolled patients reported numbness or decrease in penile penile /pe·nile/ (pe´nil) of or pertaining to the penis. pe·nile adj. Of or relating to the penis. penile of or pertaining to the penis. sensations. Commenting on these positive early stage results, Dr. Joseph Mo, president and C.E.O. of NexMed stated, "To date, we have completed testing NexMed's early ejaculation product, NM100061, in three separate studies that included more than 170 patients. The results from this most recent study are encouraging, and remain consistent with our previous findings. We intend to submit an IND filing to FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , and upon acceptance, begin clinical development in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The lack of effective treatments in the EE market presents an exciting opportunity for NexMed to become a pioneer in this area and our early human trials underscore the potential efficacy of this innovative product." EE, also known as premature ejaculation Premature Ejaculation Definition Premature ejaculation occurs when male sexual climax (orgasm) occurs before a man wishes it or too quickly during intercourse to satisfy his partner. , is the most prevalent condition of all male sexual problems, and is defined as the absence of voluntary control over ejaculation resulting in ejaculation either preceding vaginal entry or occurring immediately upon vaginal entry. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the May 2001 issue of Medical Aspects of Human Sexuality This article is about human sexual perceptions. For information about sexual activities and practices, see Human sexual behavior. Generally speaking, human sexuality is how people experience and express themselves as sexual beings. , EE affects approximately 33% of men, and is most common in adolescents, young adults, and men who lack sexual experience and frequency. Currently, no pharmaceutical product has been approved by FDA to treat the condition. NexMed currently has three products in development for treating sexual dysfunction sexual dysfunction Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems. , including the following: * Alprox-TD Cream: A proprietary product currently in Phase 3 clinical development for erectile dysfunction Erectile Dysfunction Definition Erectile dysfunction (ED), formerly known as impotence, is the inability to achieve or maintain an erection long enough to engage in sexual intercourse. . This product has been tested in over 1,700 patients and has shown statistically significant improvements with no drug- related serious side-effects. * Femprox Cream: A proprietary product currently in Phase 2 clinical development for female sexual dysfunction. Recent trial results demonstrated 77% mean percent success rate reported at the highest dose, with no drug- related serious side effects Side effects Effects of a proposed project on other parts of the firm. . * NM100061: A proprietary product being developed as a treatment for Early Ejaculation ("EE") that has demonstrated efficacy in more than 170 patients, with no serious side effects. About NexMed, Inc. NexMed, Inc. is an emerging drug developer that is leveraging its proprietary drug technology to develop a significant pipeline of innovative pharmaceutical products to address unmet medical needs. Its lead NexACT(r) product under development is the Alprox-TD(r) cream treatment for erectile dysfunction. The company is also working with various pharmaceutical companies to explore the incorporation of NexACT(r) into their existing drugs as a means of developing new patient-friendly transdermal products and extending patent lifespans and brand equity. For more information, call 609/208-9688, ext. 159 or visit http://www.nexmed.com. |
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