R&D

About

BioCorRx Pharmaceuticals, Inc. is a biopharmaceutical company and a subsidiary of BioCorRx Inc. specializing in developing treatments for substance use disorder.  However, the BioCorRx, Inc. program does not sell drugs or other compounds, any and all medications are selected and prescribed by the treating physician.


Candidate & Indication Development Stage
Preclinical Phase 1 Phase 2 Phase 3 FDA Approval
Long-acting solid depot naltrexone Opioid and Alcohol Addiction
Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
FDA Approval Phase not started

Overview

  • Focusing on the development and regulatory approval of medications utilizing 505(b)(2) pathway and/or in the addiction treatment industry
  • The lead candidate is a naltrexone pellet implanted subcutaneously being developed to address both opioid and alcohol use disorders
  • Seeking FDA approval of the naltrexone pellet and exploring other products for regulatory approval
    • FDA Pre-IND meeting held January 24, 2018
    • Awarded approximately $5.7 million from National Institute on Drug Abuse (NIDA) in January 2019 for development
    • Preclinical GLP studies commenced March 2020
    • Investigational New Drug (IND) application submitted to FDA in April 2021

Naltrexone Pellet

Naltrexone Pellet - for the treatment of opioid and alcohol use disorders

  • Biodegradable extended release subcutaneous pellet in development expected to deliver therapeutic naltrexone plasma levels for approximately 3 months
  • Similar product has been licensed in Russia for several years under the name ProdetoxoneTM*
  • Prodetoxone™ has been through multiple trials conducted at St. Petersburg Scientific-Research Center of Addictions and Psychopharmacology, Pavlov Medical University, in conjunction with the University of Pennsylvania, Department of Psychiatry, Philadelphia, USA

*BioCorRx did not license the Prodetoxone™ name and has no contractual relationship with the owner.

Potential Advantages of the Naltrexone Pellet

Potential advantages over current buprenorphine implant product:

  • Addresses both alcohol and opioid use disorders
  • Fully biodegrades, eliminating the need to remove and replace
  • Non-addictive active pharmaceutical ingredients

Potential advantages over current injectable naltrexone product:

  • Expected to maintain therapeutic plasma levels for approximately 90 days
  • Expected to be easier to remove if required for any reason