Petros Pharmaceuticals announces top-line results of expanded App Comp study

Petros announces top-line results of its expanded Application Comprehension study, which determines consumer comprehension of its unique messaging within its proprietary Technology. In the study, the Company’s technology facilitated consumer’s understanding of designated critical objectives. There were an additional 17 important objectives designated without a lower bound threshold. The 400 patient-consumer study with 31 objectives in total successfully achieved 4 of 5 among the most critical objectives, 9 of 9 of the next tier critical objectives, and all 17 important objectives exceeding an 84% LB threshold. This study is an extension of the previously announced initial App Comp study, which now incorporates 400 male subjects and showed patients interacting with the Company’s technology achieved 30 out of 31 objectives to the LB thresholds required for it to be meaningful to the FDA. These results closely follow the recently adopted “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” rules by the United States Food and Drug Administration for companies seeking Rx-to-OTC switch for pharmaceutical products. The Company’s development activities, which are currently integrating additional technologies like AI and big data integration position Petros to be a key player in future Rx-to-OTC switch activities within the sector. Petro’s recently announced focus to its primary business strategy was initially developed under guidance of previous iterations of the rule, and the Company believes the final rule will help facilitate the development of its SaMD concept, which is designed to serve the emerging self-care market. Petros has developed a proprietary technology-assisted platform that, based on multiple research studies and key enhancements, could help pharmaceutical companies pursue Rx-to-OTC switches. The Company believes that further advancement of this technology, combined with AI and big data solutions, could provide significant opportunities for future pharma partnerships among companies seeking to extend access and commercial viability of their products through an OTC switch.