madman
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Internationally Published, Head-to-Head Data From India of Petros Pharmaceuticals' STENDRA(R) (Avanafil) Tablets Reported Improvement in Erectile Function Compared to Sildenafil and Baseline After 12 Weeks of Therapy
Data Published in the "International Journal of Urology" Also Showed Secondary Endpoints, Such as Onset of action in 15 Minutes and Percentage of Patients Reaching Normal Erectile Function According to the IIEF-EF Score
NEW YORK, NY / ACCESSWIRE / September 8, 2022 / Petros Pharmaceuticals, Inc. (NASDAQTPI), a leading provider of therapeutics for men's health, today announces newly published third-party data in the International Journal of Urology Efficacy and safety of avanafil as compared with sildenafil in the treatment of erectile dysfunction by Kumar, Pathade, Gupta, Goyal, Rath, Thakre, Sanmukhani, and Mittal, detailing the Company's PDE 5 inhibitor STENDRA® (avanafil) tablets in a non-inferiority, the head-to-head study compared to sildenafil (Viagra) which was conducted in India. The primary efficacy endpoint was an improvement in erectile function based on the domain score of the International Index of Erectile Function (IIEF). Some secondary endpoints included the percentage of patients reaching a normal IIEF-EF score; the percentage of successful vaginal penetrations and successful intercourse in the two groups; and the percentage of doses with some erection in 15 mins in the two groups. The Zydus Healthcare-sponsored study, also showed rapid onset of action of STENDRA as demonstrated by a questionnaire determining whether some erection occurred within 15 minutes of dosing (see important safety information below).
"The results of this study are important for men's health as data demonstrated STENDRA, the latest entry into a long-standing ED oral administration category, provides men with a significant therapeutic option.," said Fady Boctor, Petros Pharmaceuticals' President and Chief Commercial Officer. "We believe that this study provides reason to approach Zydus Healthcare and the FDA to explore additional options. At a minimum, this study aligns with and continues to confirm the results of the pivotal, clinical trials, demonstrating that STENDRA® provides significant therapeutic value-- particularly regarding satisfactory sexual function and onset of action within 15 minutes (100mg). This is critical reinforcement for STENDRA as a prescription therapy today, but also for its relevance as a potential Over the Counter (OTC) therapy in the future."
In the prospective, randomized, double-blind, two-arm, active-controlled parallel, multicenter, non-inferiority clinical study, 220 men diagnosed with erectile dysfunction for at least three months and an IIEF domain score of less than 26, the majority were considered moderate to severe with their ED. The mean age of patients was 36.4 with a history of ED for about 8 months, and they were randomized to receive either STENDRA® (avanafil) 100 mg, or sildenafil 50 mg in a 1:1 ratio for 12 weeks. The number of doses and attempts at sexual intercourse ranged from four to 20 in the avanafil group and four to 16 in the sildenafil group during any 4-week interval between the visits. Both groups required dose escalation after four weeks of study treatment (41 of 108 avanafil patients, or 40% compared to 47 of 103 sildenafil patients, or 47%). In terms of efficacy, IIEF-EF scores increased compared to baseline for both groups, with a marked difference beginning at week 4. Erectile function scores from baseline changed from week four, where there was a score difference of 1.1 (0.2 to 2.5,) between avanafil and sildenafil. Week 8 showed a score difference of 1.4 (0.1 to 2.7), and Week 12 showed a difference of 2.1 (0.8 to 3.5,). In addition, after 12 weeks of treatment, 64.8% of avanafil patients scored "normal" for erectile function on the IIEF compared to 36.9% of sildenafil patients.
Consistent with pivotal trials for the class, the study also utilized the standard sexual encounter profile (SEP) questions to determine successful intercourse. At all three follow-up points, avanafil was compared to sildenafil (modified SEP 1 some erection within 15 minutes; SEP 2 successful vaginal penetration; SEP 3 successful intercourse). Of particular note, at 12 weeks, avanafil was compared to sildenafil in both onset of 15 minutes or less (84.8% vs. 28.2%), successful intercourse (75.1% vs. 68%), and vaginal penetration (87% vs. 81.4%).
Both compounds were well tolerated by all patients in the study, with a total of 13 adverse events reported in 11 patients in the avanafil group, and 13 adverse events in 12 patients in the sildenafil group. Most adverse events in both groups were reported as "mild," with headaches being the most commonly reported.
Some limitations to the study include a small sample size and insufficient powering to detect significant differences in safety profiles in addition to using subjective parameters to compare the efficacy of the two drugs. It is important to note the non-inferiority trial design is not intended to show one product is better than another. The study was also conducted on Indian patients and had a patient population that was younger than what was included in the pivotal trials. The authors recommend carrying out further studies to compare the efficacy of avanafil with other PDE inhibitors in patients with ED and also compare its effect with other PDE5 inhibitors in patients associated with comorbidities, such as diabetes, hypertension, cardiovascular disease, neurological disorders (such as spinal cord injury, multiple sclerosis), renal insufficiency and a history of urological pelvic surgery.
