Weston, Mass. — Medical technology company Sempresto has received positive written feedback from the U.S. Food and Drug Administration following a Type B Pre-Investigational New Drug meeting request for its investigational smartphone-integrated epinephrine auto-injector.
The company said the FDA’s responses were generally consistent with its proposed development strategy and provided additional clarity on the regulatory path toward a potential New Drug Application submission.
Sempresto submitted a briefing package containing 10 questions focused on key elements of its development and regulatory strategy for the phone-integrated drug delivery platform.
Instead of holding a meeting, the FDA provided written responses to the company’s questions.
“We are extremely encouraged by the FDA’s thoughtful and constructive feedback in the written responses from our Type B Pre-IND Meeting,” said Elizabeth Reczek, PhD, Chief Executive Officer of Sempresto. “We submitted a focused set of questions designed to validate the assumptions underlying our development strategy and to identify any issues that could materially affect our regulatory pathway. The FDA’s comments provided important clarity as we move forward.”
Sempresto is developing a drug-delivery platform designed to integrate rescue medication delivery with smartphones. Its initial product candidate is an investigational epinephrine auto-injector intended to make the medication more readily available during anaphylactic emergencies.
The company said the platform is designed to address behavioral and logistical challenges associated with carrying conventional emergency medication devices while combining drug delivery with smartphone capabilities.
Based on the FDA’s feedback, Sempresto plans to continue its development, regulatory, technical and manufacturing activities.
The company currently expects to pursue a 505(b)(2) NDA submission, subject to completion of required development work and FDA review.
