Phoenix PharmaLabs Awarded NIH/NIDA Grant to Study Non-Addictive Opioid PPL-103 for Potential use as Cocaine Addiction Therapy Drug

Research will be led by Lawrence Toll, Ph.D., chief neuropharmacologist of Phoenix, Professor, Department of Biomedical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University and president of the International Narcotics Research Conference. The grant will fund additional studies to determine if PPL-103 has potential to be used for treatment of cocaine addiction. Results from earlier in vivo studies conducted by Phoenix with NIDA support have demonstrated that PPL-103 is effective for opioid addiction therapy.

All opioids on the market today bind to the mu receptor and then aggressively stimulate that receptor. It is the mu receptor that produces the euphoria that leads to abuse and addiction of opiates. Phoenix’s drug, PPL-103 is a patented analog that binds strongly to all three opioid receptors in the brain (mu, kappa and delta) and then partially stimulates each of those receptors in a more balanced manner. This partial stimulation derives potent analgesic benefit but is not sufficiently strong to produce the serious opioid side-effects associated with any single receptor.

Dr. Toll commented that in the underlying initial research used to secure this grant, scientists at Phoenix wanted to see if PPL-103 would block relapse in cocaine-seeking rats. “Our initial study has demonstrated that the drug is effective in blocking relapse from cocaine self-administration in rodents. With the funding received, we are studying whether PPL-103 can block other things that induce relapse, such as stress and cues – the same things that induce relapse in people.”

William Crossman, CEO of Phoenix PharmaLabs, said, “Currently there are no medications that are effective for treating cocaine addiction. If we are successful in these studies, we believe this can open another avenue to pursue for the clinical use of PPL-103 along with opioid addiction therapy and treatment of moderate to severe pain.”

The company has already conducted several preclinical in vivo studies of PPL-103 as an opioid pain killer that is not addictive. These published and unpublished studies have demonstrated that PPL-103 is:

• An orally active potent pain killer (10x more potent than morphine)
• Does not cause death from overdose (even when given at 350x dose)
• Does not cause physical dependence or withdrawal
• Does not cause constipation (even at 100x dose)
• Has demonstrated potential in monkeys as an opioid addiction therapy drug replacing currently used treatments that are themselves addictive opioids

Phoenix PharmaLabs is completing additional pre-clinical work on PPL-103 as a non-addictive opioid pain treatment prior to filing an IND within approximately 18 months to commence human clinical trials.

Phoenix PharmaLabs (www.phoenixpharmalabs.com) is a privately held, preclinical drug discovery company focused on the development and commercialization of new potent, non-addictive treatments for pain and new therapies for the treatment of addiction.

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