Novel methods that restore balance in the endogenous opioid system reduce drug dependence and tolerance | Steven Crain | Pondera Pharmaceuticals, USA |

Pondera Pharmaceuticals, USA

Through more than three decades of preclinical and clinical research, our team has discovered that imbalances in the

endogenous opioid system created by exposure to opioid and other drugs are responsible, at least in part, for the development

of drug tolerance, dependence, and addiction. Specifi cally, even short-term use of these drugs can produce excessive excitatory

opioid receptor signaling as well as diminished endorphin production, as initially revealed in our electrophysiological nerve

tissue culture studies. Moreover, our research has led to the discovery of simple methods to restore balance to the endogenous

opioid system, thereby reducing drug tolerance and dependence. We have extensive evidence that the addition of ultralow-

dose naltrexone (ULDN) dramatically reduces tolerance, withdrawal symptoms, and other noxious side eff ects of opioid

drugs, including an FDA Phase III trial of 700+ lower-back pain patients. More recent research has found that specifi c

nutraceuticals, such as n-acetyl cysteine, can reduce excessive excitatory opioid receptor signaling, which when combined with

endorphin enhancers, such as caff eine, eff ectively reduce cravings for drugs and alcohol as well as food. In addition, these

novel endorphinergic nutraceutical formulations provide remarkable relief from emotional and physical distress, including

anxiety, obsessions, and compulsions. We also have had extensive experience with the challenges of the drug approval process

in the U.S. including working with the FDA, NIDA, and pharmaceutical companies, as well as the potential advantages of

translating pharmaceutical discoveries to nutraceutical formulations, which do not require FDA approval.

Addiction Research & Therapy