R&D

About

BioCorRx Pharmaceuticals, Inc. is a biopharmaceutical company and a subsidiary of BioCorRx Inc. specializing in developing treatments for substance use disorder.


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
  • Plans to seek FDA approval of naltrexone implant BICX102 and continued product development of BICX101 (injectable)
    • FDA Pre-IND meeting set for January 24, 2018 for BICX102
  • BICX102 has significant advantages over current buprenorphine implant product and current injectable naltrexone product

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 with 6-month version recently developed
  • 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 it's 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 (new version expected to reach 180 days)
  • Easier to remove if required for any reason

Injectable Naltrexone (BICX101)

  • BioCorRx has secured rights and is utilizing TheraKine's patented micro-delivery technology 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