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
BICX102 Sustained Release Depot Naltrexone Opioid and Alcohol Addiction
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
FDA Approval Phase not started
BICX101 Sustained Release Depot Naltrexone Opioid and Alcohol Addiction
Preclinical Phase in progress
Phase 1 Phase not started
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
  • The first candidate BICX102 is a naltrexone implant which addresses both opioid and alcohol use disorders
  • Seeking FDA approval of BICX102 and continued product development of BICX101 (injectable)
    • FDA Pre-IND meeting held January 24, 2018 for BICX102
    • Awarded approximately $5.7 million from National Institute on Drug Abuse (NIDA) in January 2019 for BICX development

Naltrexone Implant (BICX102)

Naltrexone Implant BICX102 - for the treatment of opioid and alcohol use disorders

Acquired North American rights to implant formulations and non-public Prodetoxone™ study data in 2016*

  • Biodegradable extended release implant provides therapeutic naltrexone plasma levels for up to 90 days
  • 3-month product has been licensed in Russia for several years
  • Non-public data acquired for Prodetoxone™, which is the most studied naltrexone implant in the world
  • 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 from its owner.

Advantages of Naltrexone Implant BICX102

Significant 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

Significant advantages over current injectable naltrexone product:

  • Maintains therapeutic plasma levels for up to 90 days (future versions expected to last longer)
  • Easier to remove if required for any reason

Injectable Naltrexone (BICX101)

  • BioCorRx owns a patented micro-delivery technology used to create an alternative product to the only other licensed existing injectable naltrexone on the market
  • Currently the product is in formulation development and pre-clinical phase

Potential Advantages of BICX101

  • Naltrexone in a suspended release injectable
  • Longer drug release than current product
  • Intended administration; IM deltoid injection or subcutaneous
  • Smaller gauge needle
  • Should not require refrigeration
  • Smaller dose volume

Patent Portfolio

1Includes further development of a specific formulation and drug patent
2Includes further relevant patents dependent upon these cited through continuation or division or expansion from PCT into National Phases