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

Published on Feb. 24, 2026

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Consegna Pharma, Inc. 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. 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 and 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.

Why it matters

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.

The details

The FDA's written responses recognize the scientific rigor and innovation of Consegna's modeling‑driven strategy, which 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. 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.

  • The FDA's written responses were received on February 24, 2026.

The players

Consegna Pharma, Inc.

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.

Larry Zana

President and CEO of Consegna Pharma.

Darren Wolfe

Chief Scientific Officer of Consegna Pharma.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States.

National Institute on Drug Abuse

A component of the National Institutes of Health, the primary agency of the United States government responsible for conducting and supporting research on the causes, consequences, prevention, and treatment of drug abuse and addiction.

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What they’re saying

“The Agency's written responses recognize the scientific rigor and innovation of our modeling‑driven strategy.”

— Larry Zana, President and CEO of Consegna Pharma (Consegna Pharma Inc.)

“Our streamlined development program for CP217 systematically addresses key questions of dose, extended exposure profile, safety, drug pharmacokinetics, and renarcotization simulation”

— Darren Wolfe, Chief Scientific Officer (Consegna Pharma Inc.)

What’s next

Consegna Pharma plans to explore strategic partnerships to maximize the impact of CP217 against the synthetic opioid epidemic.

The takeaway

Consegna Pharma's innovative modeling and simulation strategy, which the FDA has recognized as appropriate to guide the clinical development program for CP217, represents a novel and highly efficient approach to pursuing 505(b)(2) approval for a long-acting opioid overdose reversal drug.