The development of controlled-release opioids has greatly facilitated the expansion of opioid analgesic use in the USA. However, concerns about the abuse of prescription opioids and, more recently, opioid overdose deaths related to these products, including deaths involving patients using these products legitimately that may hinder access to them in the future.
The FDA has stated that “there currently are no products with demonstrated or purported reduced abuse liability on the market.” More people die from prescription opioid abuse than from heroin and cocaine combined. Methadone and Buprenorphine are opioid substitution therapies that currently dominate the addiction treatment market. Patients need to have access to safe and effective treatment alternatives to break free of their intractable cycle of abuse and dependence.
Dr. Deborah Mash, Founder of DemeRx, discovered and advanced the science behind the molecule. She spent over twenty years conducting both preclinical and clinical studies working first with Ibogaine in FDA approved clinical trials. NorIbogaine is a long-acting metabolite that may mediate some of the beneficial aftereffects of Ibogaine treatment.
Our review of clinical data from over 250 patients who used Ibogaine for drug detoxification supports the safety, efficacy, and our plan to conduct a Phase 2 proof of concept clinical study.
DemeRx has advanced NorIbogaine in first in human clinical trials. Since clinical trials take many years to gain regulatory approval, we plan to work with regulatory health authorities to obtain fast track review of Ibogaine for medically-assisted detoxification of opioid dependent patients, including heroin and other prescription drugs.
DemeRx has secured GMP drug supplies of Ibogaine and NorIbogaine and the company stands ready to work with government and industry partners to address the current opioid abuse crisis in North America.
NorIbogaine is an indole alkaloid with an atypical opioid pharmacology that may offer unique opportunities to improve the treatment of opioid addiction and to limit tolerance to opioid pain medications. We also plan to develop NorIbogaine as a subchronic adjunct therapy to support patients after Ibogaine detoxification who are in early recovery.
Ibogaine was originally developed and studied in France, where it was marketed from 1939 – 1970 under the tradename Lamberene in low dose 8 mg tablets. We demonstrated in our early US FDA clinical trials conducted at the University of Miami that low doses of Ibogaine are totally converted by the liver to NorIbogaine.
Noribogaine has pharmacologic properties that distinguish it from methadone, buprenorphine and the major opioid analgesics in clinical use today. In animal models of addiction, noribogaine blocks opioid, cocaine, nicotine and alcohol self-administration suggesting that low dose Noribogaine may prove effective as an abstinence-based therapy for opioid and possibly other drug addictions.
Our business development strategy for Ibogaine and Noribogaine is focused on the following indications:
Products for Substance Dependence:
Products for Pain Management:
*Fast Track designation for Subpart H approval with REMS Program
Deborah C. Mash, Ph.D. email@example.com
CEO and Founder DemeRx, Inc.
Professor of Neurology (Emeritus) and
Molecular and Cellular Pharmacology
Miller School of Medicine
University of Miami