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August 5, 2013
Eli Lilly issued results from a randomized, double-blind, parallel, placebo-controlled trial of Cialis, for the treatment of erectile dysfunction (ED). The study was conducted at 51 sites in the U.S. and Canada and enrolled 623 men with ED aged 18 years and older who had some response (IIEF-EF >/= 17) but were unable to reach normal erectile function (IIEF-EF <26) while on a maximum dose of an as needed PDE5 inhibitor treatment. The International Index of Erectile Function-Erectile Function Domain (IIEF-EF) is a questionnaire evaluating sexual function in which higher scores indicate better erectile function. Treatment with Cialis 2.5mg to 5mg and 5mg met the primary endpoint, resulting in significantly higher percentages of men (38.7% and 39.6%, respectively) with IIEF-EF domain scores in the normal range (>/= 26) through 12 weeks v. placebo (12.1%; both, p<.001). For the secondary objective, improvements in the IIEF-EF domain score were statistically significant for the tadalafil 2.5mg to 5mg group (8.1) and the tadalafil 5mg group (8.0), compared to the placebo group (1.9; both, p<.001).
December 13, 2010
Vivus released positive results from a phase III trial of avanafil for the treatment of erectile dysfunction (ED). This pivotal open-label, long term extension trial enrolled 712 subjects with mild to severe ED who had participated in one of two prior phase III trials. The subjects took 50 mg. 100 mg or 200 mg of Avanafil as needed and evaluated for 52 weeks. The trial met all primary endpoints by demonstrating improvement from baseline in erectile function, as measured by the Sexual Encounter Profile (both SEP2 and SEP3). For the SEP2 measurement, 80% of sexual attempts among subjects on avanafil had erections sufficient for intercourse. For the SEP3 measurement, 67% of patients taking avanafil experienced successful intercourse. Successful intercourse was achieved as early as 15 minutes after dosing. Avanafil was well tolerated.
November 30, 2009
Vivus reported positive results from a phase III trial of avanafil for the treatment of erectile dysfunction (ED). This randomized, double-blind, placebo-controlled study, dubbed REVIVE, enrolled 646 men with a history of generalized ED for at least six years. The subjects underwent a four-week run-in, no treatment period followed by 12 weeks of treatment with one of three dose levels of avanafil (50mg, 100 mg and 200mg) or placebo. They were asked to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. All three doses met the primary endpoints, improvement in erectile function as measured by the Sexual Encounter Profile and improvements in the International Index of Erectile Function score, with statistical significance. Full efficacy was seen in 30 minutes or less, and based on patient reported outcomes, the duration of full effect lasted beyond six hours.
May 18, 2009
Eli Lilly reported positive results from a clinical trial of tadalafil once daily for the treatment of erectile dysfunction (ED). This 16-week double-blind, multi-center, randomized study followed 342 men with a minimum three-month history of ED. In the first, four-week run-in phase of the study, the subjects remained treatment-free and were asked to make a minimum of four sexual attempts with their partners. In the second, 12-week treatment phase of the study, the subjects were randomized to receive either a placebo or tadalafil 5 mg taken once daily and were asked to make at least one sexual attempt with their partner per week. Throughout the study, evaluations were made based on the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain, Sexual Encounter Profile (SEP) diary and the Sexual Quality of Life (SQoL) domain of the Sexual Life Quality Questionnaire (SLQQ). Results showed that tadalafil 5 mg daily significantly improved erectile function according to changes from baseline measured by the IIEF and SEP. The average increase from baseline to endpoint in the IIEF-EF domain was 7.9 points in the tadalafil group, compared with 0.7 points in the placebo group. The tadalafil treatment group reported a 28.6% increase on average in the ability to achieve an erection sufficient for vaginal penetration, compared with 2.7% in the placebo group. When asked if their erections lasted long enough for successful intercourse, the tadalafil group reported a 46% increase on average in positive responses from baseline to endpoint, compared with 10.8% in the placebo group. Significant improvement in the SQoL score was also reported in the tadalafil treatment group; the average increase from baseline to endpoint for was 39.5 points, compared with 12.5 point increase in the placebo group.
April 30, 2007
Vectura issued positive results from a phase IIb trial of VR004 for the treatment of erectile dysfunction. This double-blind, placebo-controlled trial enrolled 241 subjects. Following a four week "no treatment" run-in period, subjects were randomized to either placebo or VR004 at one of three doses (100 g, 150 g and 200 g) for 12 weeks. The primary endpoints were changes from baseline in positive responses to Sexual Encounter Profile (SEP) questions 2, a measure of the ability of a patient to achieve vaginal penetration and 3, the ability of a patient to maintain an erection suitable for successful intercourse. Statistically significant improvements for SEP 2 and 3 were seen at all doses when compared to placebo (p<0.001). The mean onset of erectile function was dose dependent, with 60% responding to VR004 within five minutes of dosing and 85% responding within 10 minutes. Based on the results, Vectura is undergoing discussions with potential licensing partners prior to commencing phase III trials.
November 13, 2006
Palatin and King announced positive results from two phase IIb trials, study 16 and 17, of bremelanotide for the treatment of male erectile dysfunction (ED). Both double-blind, placebo-controlled and parallel dose trials had a primary endpoint of a change in the Erectile Function domain of the International Index of Erectile Function (IIEF-ED) from baseline to the end of the three-month treatment period. Study 16 enrolled 726 non-diabetic ED subjects. The subjects were randomized to receive bremelanotide or placebo at doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg, for three months. Treatment was well tolerated across all doses. The incidence of adverse events was dose related, with the most commonly reported events including nausea, emesis, headache and prolonged erection. The primary endpoint was reached, with statistical significance (a change of 4 points from baseline) observed for all doses. IIEF-ED changes ranged from 5.7 for the 7.5 mg dose to 8.4 for the 15 mg dose, compared to 1.8 for placebo. Study 17 enrolled 294 diabetic ED subjects. The subjects were randomized to receive bremelanotide or placebo at doses of 10 mg, 12.5 mg or 15 mg. Adverse events were similar to those observed in Study 16. The primary endpoint was reached, with statistical significance observed in the 12.5 mg and 15 mg dose groups, with IIEF-ED changes of 5.9 and 7.1, respectively, versus 2.3 for placebo. Based on these results Palaltin and King are preparing for an end-of-phase II meeting with the FDA.
November 28, 2005
Surface Logix announced positive results of a phase I trial of their investigational PDE-5 inhibitor SLx-2101, for the treatment of endothelial and erectile dysfunction, at the 2005 Sexual Medicine Society of North America meeting. Results from the study yielded preliminary evidence of efficacy in both erectile and endothelial endpoints, with clinically meaningful erectile activity observed via RigiScan plethysmography, and improved endothelial function through 9.5-24 hours post treatment observed via RH-RAT index (based on dose level). Treatment was generally safe and well-tolerated, with headache observed most frequently. This double-blind, placebo controlled, randomized study enrolled 40 healthy male volunteers, who received one of 5 doses of the drug (5, 10, 20, 40 or 80 mg) or placebo. Based on these results, the company announced plans to initiate phase II trials for both indications before year's end.
March 28, 2005
Palatin Technologies and King Pharmaceuticals reported positive results of a clinical trial of their investigational intranasal melanocortin receptor agonist PT-141, for the treatment of erectile dysfunction (ED). Results from the trial indicated that addition of the drug to standard therapy with sildenafil produced no significant safety concerns or incidence of adverse events, and increased the duration of erectile activity by a mean factor of 5.3 (range: 1.9 - 8.3), compared to treatment with sildenafil alone. This open-label study enrolled 32 ED patients already receiving treatment with sildenafil (50 mg or 100 mg doses), half of whom were randomized to receive one of two intranasal doses of PT-141 (7.5 mg or 10 mg).The company announced that these results would serve to support ongoing phase II trials of the drug for the treatment of both ED and female sexual dysfunction.
November 22, 2004
Auxilium Pharmaceuticals reported positive results of a clinical trial of their approved testosterone replacement gel Testim in hypogonadal HIV-positive men. Top-line results indicate that the drug was efficacious in treating symptoms of hypogonadism, with significant improvements observed in reported sex drive, erectile function, and sexual-satisfaction with sex life, as well as satisfaction with androgen therapy. These improvements in sexual function resulted in a significantly fewer Testim treated men requiring titration to a higher dose compared to men treated with AndroGel, another approved topical testosterone therapy (30% vs. 74%; p<0.05). This approved-therapy controlled study enrolled a total of 48 HIV-positive hypogonadal men who had not achieved adequate symptom relief on AndroGel.
September 20, 2004
Auxilium Pharmaceuticals has reported the results of a phase IV study of their topical testosterone therapy Testim, for the treatment of hypogonadism in men unable to achieve symptom amelioration with AndroGel, another topical testosterone therapeutic. The study found that Testim therapy was effective in treating symptoms of hypogonadism, significantly improving sexual function and satisfaction, compared with men remaining on a comparable dose of AndroGel. In addition, a significantly higher portion of subjects receiving Testim did not require dose escalation to achieve results at the end of the study period, compared with AndroGel. The study enrolled a total of 151 hypogonadal men who were refractory to or insufficiently served by AndroGel therapy; these subjects were randomized to receive either continued treatments with AndroGel or Testim once daily for 4 weeks.
May 24, 2004
Dong-A PharmTech reported positive results from a phase I trial investigating DA-8159, a PDE 5 inhibitor for the treatment of erectile dysfunction (ED). Data showed DA8159 had a Tmax of 1.0-1.5 hours and a half-life of 11-13 hours. The most frequently reported side effects were spontaneous erections and headaches. The double-blind, placebo controlled study was designed to test a ascending single doses of 50, 100, 200 and 400mg and multiple doses of 100 and 200mg on healthy subjects. Adverse events, vital signs, 12-lead ECG, clinical laboratory tests, physical examination and pharmacokinetic profile were assessed. Results were reported at the 99th Annual Meeting of the American Urological Association in San Francisco. The company announced plans to file an IND in the U.S. during 2004.
Palatin Technologies reported positive results from a phase IIb trial investigating PT-141, an analog of alpha-melanocyte-stimulating hormone for the treatment of erectile dysfunction (ED). Results showed that treatment with PT-141 improved erectile function compared with placebo. Improvement was measured by a statistically significant increase in IIEF-EF domain scores and improvement in the quality of erections as assessed by the global assessment questionnaire score. The parallel-group, double-blind, randomized, placebo-controlled trial enrolled 271 subjects with moderate-to-severe ED at 21 sites in the U.S. Subjects received intranasal PT-141 at 5, 10, 15 or 20 mg or placebo for four weeks. The primary end point of the study was the change in a patient's erectile function domain of the International Index of Erectile Function (IIEF) score after PT-141 treatment versus their baseline score. Results were reported at the 99th Annual Meeting of the American Urological Association in San Francisco.
April 19, 2004
MacroChem Corporation reported negative preliminary results from a phase II trial investigating Topiglan, a synthetic prostaglandin E1in a topical cream formulation, for the treatment of erectile dysfunction. Results demonstrate that Topiglan did not meet the study's primary clinical endpoints. The randomized, placebo-controlled, double-blind study compared the efficacy of Topiglan in men with mild-to- moderate erectile dysfunction to a placebo cream. The trial measured efficacy using the RigiScan monitoring technique.
October 20, 2003
Eli Lilly reported positive new data from a serious of clinical trials investigating Cialis (tadalafil), a PDE5 inhibitor for the treatment of erectile dysfunction. Results demonstrated that 62% of men who underwent bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP) reported improved erections after taking the drug. Data showed that 82% of men attempted intercourse at least once between four hours and up to 36 hours after taking the drug over a 12-week period. The trial was a phase III multi-center enrolling 303 men who had undergone surgery 12-48 months pre-study. The most commonly reported drug related adverse events were headache, upset stomach and muscle ache. Results were presented at the annual meeting of the Sexual Medicine Society in Denver.
July 28, 2003
Vectura Limited reported positive results from a phase IIa trial investigating VR004 (inhaled apomorphine), a neuroactive agent for the treatment of erectile dysfunction. Results showed that VR004 improved erectile performance with a rapid onset of action compared with placebo and demonstrated excellent tolerability at all doses tested. The proportion of subjects achieving Grade 3 or 4 erectile performance was 49% and 59% respectively compared with 31% for placebo. The placebo-controlled, escalating dose study enrolled 35 subjects with mild to moderate ED and was designed to test the efficacy and tolerability of VR004 in 200, 400 and 800 ug doses. Erectile performance was assessed in response to visual stimuli in a clinic setting using a modified version of Question 4 of the International Index of Erectile Function questionnaire.
June 16, 2003
Nastech reported mixed results from a phase II trial investigating intranasal apomorphine, a dopamine agonist for the treatment of female sexual dysfunction. Results showed that in women taking intranasal apomorphine (0.5 mg) a statistically significant improvement from baseline was achieved in many areas including, sexual relationship satisfaction, overall sexual life satisfaction, arousal frequency, arousal intensity and maintaining the aroused state. Data demonstrated however, that the difference between apomorphine and placebo treatments did not reach statistical significance. The study enrolled 38 pre-menopausal women who had been diagnosed with female sexual arousal disorder. Adverse events in both the apomorphine and placebo groups were generally mild with no observations of flushing, nausea, vomiting, hypotension or syncope.
NexMed reported positive results from two pivotal phase III trials investigating Alprox-TD, a alprostadil transdermal cream for the treatment of erectile dysfunction (ED). Results demonstrated that the three dose levels of Alprox-TD tested were effective over placebo in each study and in the combined analysis of the two studies. All doses showed a highly significant increase in Erectile Function Domain scores using the International Index of Erectile Function (IIEF), the standard for measuring efficacy in ED products. The side effects reported were mostly mild to moderate, localized and transient. The overall discontinuance rate due to side effects was less than 4%. The randomized, double blind, placebo-controlled studies enrolled over 1,700 subjects with mild to severe ED and were conducted at 85 sites in the U.S.
May 5, 2003
Lilly reported positive results from a phase III trial investigating Cialis (tadalafil), a phosphodiesterase type five inhibitor for the treatment of erectile dysfunction (ED). Results showed that 79% of subjects treated with Cialis reported improved erections, as determined by the Global Assessment Question, compared with 19% on placebo. Data also demonstrated that 77% of attempts at penetration were successful for subjects on Cialis, as recorded in the Sexual Encounter Profile diary compared with 43% on placebo. In addition, men taking Cialis were able to complete 64% of sexual intercourse attempts compared with 23% for men taking placebo. The 12-week, randomized, placebo-controlled study enrolled 207 subjects in the U.S. and Puerto Rico.
January 27, 2003
Palatin Technologies reported positive results from a phase IIa trial investigating PT-141, a melanocortin receptor activator for the treatment of male erectile dysfunction (MED). Results showed that PT-141 demonstrated a highly significant effect on time of penile base rigidity (greater than 60% of full base rigidity) versus placebo. Significant results were also demonstrated from the secondary endpoint, time of penile base rigidity (greater than 80% of full base rigidity) versus placebo. Greater than 80% of subjects who enrolled in the trial received erections sufficient for intercourse after treatment. The drug was well tolerated with no significant adverse events reported. Efficacy was evaluated using RigiScan, a standardized device that measures penile rigidity and tumescence. The placebo controlled, randomized, double-blind study enrolled 24 male subjects with MED who had a history of inadequate responses to Viagra (sildenafil citrate).
June 10, 2002
Positive initial results were reported from a phase IIa trial of PT-141, Palatin Technologies' intranasal treatment for erectile dysfunction. The placebo-controlled trial enrolled 24 subjects with mild-to-moderate erectile dysfunction. Subjects received PT-141 or placebo by intranasal administration, and efficacy was evaluated using RigiScan. In terms of the primary endpoint, duration of erection with greater than 60% rigidity, PT-141 produced significant improvement compared to placebo.
December 17, 2001
Positive results were reported from the first pivotal phase III data on vardenafil, an investigational phosphodiesterase-5 inhibitor being developed by Bayer for erectile dysfunction (ED). The double-blind, placebo-controlled trial included 736 subjects over age 18 with ED of varying severity and causes. The study population included subjects with underlying conditions, including hypertension, diabetes and enlarged prostate. Subjects were evaluated at 12 and 26 weeks using the General Assessment Question (GAQ). At 26 weeks, subjects reported an 85% improvement in erections with a 20 mg vardenafil dose, compared to 28% for subjects receiving placebo. Subjects receiving 10 mg and 5 mg of vardenafil reported significant improvements in erectile function of 80% and 65%, respectively.