Consegna Pharma Receives NIH Research Grant to Develop CP216, a Sustained-Release Naloxone Treatment for Opioid Overdose Reversal

Long-acting naloxone can potentially help to prevent renarcotization.

Consegna Pharma Inc. today announced a research grant awarded by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), valued at approximately $218,000 for the continued development of CP216, the company’s sustained-release naloxone formulation for the reversal of opioid overdoses. The award is being made under NIH’s HEAL (Helping to End Addiction Long-termSM) Initiative that was launched in 2018 to improve prevention and treatment strategies for opioid misuse and addiction and enhance pain management. Consegna’s award is one of 375 grant awards across 41 states made by the NIH in fiscal year 2019 to apply scientific solutions to reverse the national opioid crisis.

70,237 drug overdose deaths occurred in the United States in 2017. Opioids—mainly synthetic opioids such as fentanyl—are currently the primary driver of drug overdose deaths. While naloxone has proven invaluable as an opioid overdose antidote, naloxone suffers from a very short duration of action (about 1hr.) and has been found to be less effective against newer, long acting synthetic opioids including fentanyl (about 7-10 hrs.). This leads to a highly lethal and increasingly prevalent phenomenon known as “renarcotization”, wherein an overdose patient revived with naloxone can re-enter an overdose state due to residual fentanyl in the body.

“We are pleased to be among the organizations selected to receive a Phase I award,” said Larry Zana, President and CEO. “Consegna has dedicated itself to the mission of addressing the opioid crisis with novel polymer-based formulations. We believe that CP216 has the potential to save lives by reducing the incidence of renarcotization.”

CP216 is a novel microparticle formulation that provides an immediate release of naloxone to reverse an overdose, followed by a continuous release of naloxone over the next 24hrs to prevent renarcotization. This Phase I STTR award will enable Consegna to conduct non-clinical studies and activities to demonstrate proof-of-concept for CP216.

“It’s clear that a multi-pronged scientific approach is needed to reduce the risks of opioids, accelerate development of effective non-opioid therapies for pain and provide more flexible and effective options for treating addiction to opioids,” said NIH Director Francis S. Collins, M.D., Ph.D., who launched the initiative in early 2018. “This unprecedented investment in the NIH HEAL Initiative demonstrates the commitment to reversing this devastating crisis.”

This grant award is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number R41DA050386. 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 the NIH HEAL Initiative: The National Institutes of Health launched the HEAL (Helping to End Addiction Long-termSM) Initiative in April 2018 to improve prevention and treatment strategies for opioid misuse and addiction and enhance pain management. The NIH HEAL Initiative aims to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose and facilitate long-term recovery from opioid addiction.


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About Consegna Pharma: Consegna Pharma reformulates FDA approved drug products and creates new, long-acting injectable (LAI) medications with improved clinical and economic benefits. Consegna’s product pipeline focuses on therapeutic areas where LAIs offer high therapeutic and economic value, such as addressing high non-adherence, improving efficacy, reducing side effects, or solving specific drug delivery challenges. The company uses its artificial intelligence-based Computational Drug Delivery™ technology, called ADSR™, to design LAIs significantly faster than legacy practice and with reduced clinical and technical risk.