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Petros Pharmaceuticals announces the expansion of the FDA labeling for its oral erectile dysfunction drug, STENDRA, marketed by its subsidiary, Metuchen Pharmaceuticals. The expanded label now includes positive clinical trial data on STENDRA use by men with ED who have undergone radical prostatectomy. The clinical trial included in the new FDA-approved labeling evaluated 286 patients with ED following radical prostatectomy in a randomized, double-blind, parallel, placebo-controlled fixed dose trial of 3 months in duration. For study inclusion, patients had to experience ED following bilateral, nerve-sparing radical prostatectomy. Study subjects received STENDRA 100 mg or 200 mg once daily. A statistically significant improvement in all 3 primary efficacy variables relative to placebo was found for both studied doses.

Petros Pharmaceuticals announces the expansion of the FDA labeling for its oral erectile dysfunction drug, STENDRA avanafil, marketed by its subsidiary, Metuchen Pharmaceuticals. The expanded label now includes positive clinical trial data on STENDRA use by men with ED who have undergone radical prostatectomy. The clinical trial included in the new FDA-approved labeling evaluated 286 patients with ED following radical prostatectomy in a randomized, double-blind, parallel, placebo-controlled fixed dose trial of 3 months in duration. For study inclusion, patients had to experience ED following bilateral, nerve-sparing radical prostatectomy. Study subjects received STENDRA(R) (avanafil) 100 mg or 200 mg once daily. A statistically significant improvement in all 3 primary efficacy variables relative to placebo was found for both studied doses. "Our ongoing goal remains to expand access of STENDRA to as many men who need it as possible," commented Fady Boctor, Petros's President and Chief Commercial Officer. "Whether it is through a label expansion that now includes a significant population of men who were not covered under the previous labeling, or ultimately applying to ensure that STENDRA can be obtained OTC, we believe every opportunity to increase the availability of STENDRA is an opportunity to improve the lives of more men who suffer from ED. We are grateful to the FDA for their ongoing collaboration in this label expansion and will continue to work closely with the Agency moving forward."

Petros Pharmaceuticals 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 tablets in a non-inferiority, head-to-head study compared to sildenafil which was conducted in India. The primary efficacy endpoint was improvement in erectile function based on domain score of the International Index of Erectile Function. Some secondary endpoints included, the percentage of patients reaching a normal IIEF-EF score; percentage of successful vaginal penetrations and successful intercourse in the two groups; and 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. 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, 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 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. 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 score difference of 1.1 between avanafil and sildenafil. Week 8 showed a score difference of 1.4, and Week 12 showed a difference of 2.1. 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 questions to determine successful intercourse. At all three follow-up points, avanafil was compared to sildenafil. Of particular note, at 12 weeks, avanafil was compared to sildenafil in both onset of 15 minutes or less , successful intercourse and vaginal penetration. 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 headache being the most commonly reported. Some limitations to the study include 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 in 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, renal insufficiency and a history of urological pelvic surgery.

Petros Pharmaceuticals confirmed that a press release issued on July 28, 2022 regarding a purported acquisition of the company was fraudulent and not issued by the Company. The Company is not a party to any such acquisition and has reported the fraudulent activity to Nasdaq.