Petros Pharmaceuticals has decided on the way forward for its topical treatment of a connective tissue disorder of the penis. After talking to the FDA, Petros plans to follow the 505(b)(2) pathway, enabling it to leverage data on approved drug products to support its application.
The candidate slated for 505(b)(2) development is H-100, a topical formulation of the calcium channel blocker nicardipine. Petros acquired a license to the candidate from Hybrid Medical in 2020, positioning it to build on earlier work including a 22-subject trial to establish H-100 as a treatment for Peyronie’s disease. The disease is characterized by bent and painful erections.
Petros has previously expressed a desire to develop the candidate via the 505(b)(2) pathway. Recently, those hopes firmed up into a concrete plan, with Petros exiting talks with the FDA with the belief that the candidate is eligible for the pathway. The pathway could cut the time it takes to get H-100 to market.
“We believe that H-100 represents a much needed therapeutic advancement as potentially the first non-invasive treatment for a painful and debilitating condition that currently has few viable options. We look forward to working closely with the FDA as we pursue the 505(b)(2) pathway, significantly shortening the development timeline needed to bring H-100 to men, and to their partners, living with Peyronie’s disease,” Fady Boctor, president and chief commercial officer at Petros, said in a statement.
Other researchers have tested the effects of injecting nicardipine directly into the affected tissue. Petros’ approach is designed to boost permeation of the molecule, thereby enabling the delivery of enough drug to address the inflammatory cascade after topical application of the formulation.
Endo became the first company to win FDA approval for a drug treatment of Peyronie’s in 2013. Sales of the drug, which is also approved in another indication, grew 37% last year to $432 million.