Therapy Areas: Devices
First Subjects Dosed in Phase 1 Clinical Trial of Once or Twice-Yearly Naltrexone Implant for Opioid Addiction
28 April 2022 - - US-based biopharmaceutical company Delpor, Inc has initiated and dosed the first subjects in a phase 1 clinical trial of DLP-160, a 6-12-month formulation of naltrexone for the treatment of opioid use disorder, the company said.

This is an open-label study in healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of naltrexone when administered in sequence of Naltrexone HCL, DLP-160 (Naltrexone Implant), followed by Vivitrol (Intramuscular).

This is Delpor's second product to reach the clinical development milestone behind its lead asset, DLP-114, a once-yearly risperidone implant for the treatment of schizophrenia which is currently in phase 1b/2a.

The CDC states that overdoses are the leading injury-related cause of death in the United States and appear to have accelerated during the COVID-19 pandemic.

Naltrexone is one of the three FDA-approved medications used to treat OUD, but its effectiveness can be limited by difficulties with medication adherence.

The longest acting naltrexone formulation currently available is once-monthly.

According to the Centers for Disease Control and Prevention's Drug Overdose "Get the Facts" website, in 2020, nearly 92,000 people died from drug overdoses, a 31% increase from the approximately 71,000 overdose deaths in 2019. 75% of the 2020 overdose deaths involved a prescription or illicit opioid.

In 2020, an estimated 41.1m Americans needed substance use disorder treatment, only 2.6m received treatment.

Delpor's Prozor technology enables the sustained release of drugs from a non-mechanical, matchstick-long, implantable drug delivery device based on a unique formulation.

The device is implanted in the abdomen during a simple, 10-minute in-office procedure, and delivers therapeutic levels of the drug for as long as one year.

Potential benefits include reduced relapses due to complete medication adherence for as long as one year after a single administration, and steady drug release without any adverse event inducing peaks, or sub-therapeutic troughs.

Delpor is a clinical stage biopharmaceutical company that utilizes innovative technologies to develop once-yearly therapeutics for chronic conditions.

The company's lead product is a 6-12-month formulation of Risperidone for the treatment of schizophrenia. Delpor is also pursuing 6-12-month formulations of other drugs targeting CNS conditions including schizophrenia, addiction, spasticity, Parkinson's, Alzheimer's, and other conditions.

DLP-160 is an investigational therapy that employs Delpor's proprietary technology platform. It utilizes a matchstick-long implant device, that is placed sub-dermally to provide continuous and consistent drug therapy of naltrexone lasting for 6-12 months for the treatment of opioid use disorder.

Research for DLP-160 is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number 5UG3DA050306.