North Liberty-based Steel Therapeutics, an early stage pharmarceutical company focused on increasing access to compounded drug therapies, announced Sept. 12 it has completed pre-investigational New Drug Application (pre-IND) communications with the U.S. Food and Drug Administration for its first product candidate, the Fizurex wipe.
Fizurex is a single use, disposable wipe that utilizes combination therapy commonly compounded by pharmacists in cream form. Research shows this chemical combination increases blood flow and can lead to healing rates of nearly 90% for those that suffer from anal fissures, according to their website.
Pre-IND engagements provide an opportunity for companies and the FDA to discuss a drug’s development plan and to obtain the agency’s guidance for studies of the company’s drug candidates.
“The FDA did not object to our proposed development path and otherwise offered feedback that is aligned our vision and desired timeline,” said Steel CEO and Founder Matt Stahl. “The correspondence gives us confidence in our approach to bringing the Fizurex wipe to patients at scale.”
FDA feedback found the Fizurex wipe “reasonable,” according to the release.
“One of the core value propositions of Steel is that we help get drugs that are seeing high rates of utilization in compounding pharmacy into the hands of patients safely, efficiently and in more user-friendly formats than are available today,” added Mr. Stahl.