Consegna Pharma Highlights Innovative Modeling and Simulation Strategy as FDA Concurs with Regulatory Pathway for CP217 to Prevent Fentanyl Epidemic Deaths

Prevention of Renarcotization after Rescue from Opioid Overdose is a New Indication and Planned Clinical Studies will be Supported by Pioneering a First-of-Its-Kind, Capital Efficient, Modeling and Simulation-Driven 505(b)(2) Pathway

PITTSBURGH, Feb. 24, 2026 /PRNewswire/ — Consegna Pharma, Inc. (“Consegna” or the “Company”) today announced that it has received written responses from the U.S. Food and Drug Administration (FDA) regarding its Type C meeting for CP217, the Company’s investigational long‑acting naloxone product being developed for the prevention of renarcotization following rescue from opioid overdose.

In its feedback, the FDA concurred that the proprietary modeling and simulation (M&S) framework proposed by Consegna is appropriate to guide the clinical development program for CP217. The Agency recognized the proposed labeling indication, prevention of renarcotization when residual opioid effects extend beyond the duration of initial naloxone rescue, as a distinct and clinically relevant labeling objective. This guidance also concurred that substantial evidence of effectiveness for this new indication can be supported by the combined M&S, bioavailability, and clinical safety package.

“The Agency’s written responses recognize the scientific rigor and innovation of our modeling‑driven strategy,” said Larry Zana, President and CEO of Consegna Pharma. “This approach expands and improves proven in silico mechanistic models of opioid overdose, respiratory depression, and renarcotization to generate evidence of CP217’s effect in vast, virtual patient populations, reducing reliance on large, expensive, and time-consuming clinical efficacy trials. With the FDA’s guidance, we now have a clearly defined, capital‑efficient path to NDA filing and we look forward to exploring strategic partnerships to maximize its impact against the synthetic opioid epidemic.”

“Our streamlined development program for CP217 systematically addresses key questions of dose, extended exposure profile, safety, drug pharmacokinetics, and renarcotization simulation”, said Darren Wolfe, Chief Scientific Officer. “A single, clinical bioavailability and safety study will be central to our accelerated 505(b)(2)approval strategy.”

Consegna’s approach aligns with the FDA’s Model‑Informed Drug Development (MIDD) and Quantitative Medicine initiatives that promote advanced modeling to streamline development, reduce or replace selected animal studies and human clinical trials, and accelerate regulatory decision‑making. The Agency has identified M&S‑driven strategies as important tools for optimizing dose selection and demonstrating therapeutic effect when traditional trials are impractical or duplicative.

In its responses, the FDA confirmed that the 505(b)(2) regulatory pathway appears appropriate for CP217 and outlined expectations for establishing a robust scientific bridge to the listed naloxone drug using comparative pharmacokinetic data collected under standard dosing conditions. This represents a novel and highly innovative application of modeling‑driven, long‑acting drug delivery to pursue 505(b)(2) approval, using an integrated package of advanced M&S, comparative pharmacokinetics, and targeted clinical safety data to support prevention of the new indication of renarcotization.

This work was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number 2R43DA059056. The content of this press release is solely the responsibility of the company and does not necessarily represent the official views of the National Institutes of Health.

About CP217

CP217 is a microencapsulated, long‑acting injectable formulation of naloxone hydrochloride engineered to provide 12-24 hours of sustained opioid receptor antagonism following a single dose. It is being developed for the prevention of renarcotization when residual opioid effects extend beyond the duration of initial naloxone rescue in overdose patients with acute opioid toxicity.

About Consegna Pharma

Consegna Pharma, Inc. is a privately held biopharmaceutical company focused on applying advanced long‑acting drug delivery and quantitative clinical pharmacology to develop differentiated therapeutics in addiction medicine, non-opioid pain, and emergency response. The company’s pipeline includes long‑acting formulations such as CP217 for overdose reversal, CP110 to treat substance use disorder, FP111 for post-surgical pain and several pre-lead drug candidates as long‑acting, non‑opioid pain therapeutics designed to address unmet needs in the prevention and management of acute and chronic pain.

Media Contact:
Larry Zana, President and CEO
Phone: +1-412-213-8788
Email: [email protected]

SOURCE Consegna Pharma Inc.

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