Phoenix PharmaLabs Releases New Data Confirming That Their Novel Opioid Shows No Signs of Addiction Potential

Jan 06, 2016, 11:12 ET from Phoenix PharmaLabs, Inc.

SALT LAKE CITY, Jan. 6, 2016 /PRNewswire/ -- Phoenix PharmaLabs, Inc. ("Phoenix"), announced today that Torrey Pines Institute for Molecular Studies (TPIMS) has now completed studies of the Company's advanced analog known as PPL-103 using the self-administration paradigm in rats. This procedure, in which rats press a lever for delivery of drug, is generally considered to be the gold standard to determine whether a compound induces euphoria - which leads to abuse and addiction. Research has shown that this study has a very high correlation to Human Abuse Liability (HAL) studies and other indications of the potential for abuse and addiction in humans [1].

In this study the rats pressed the lever for morphine very actively, but the level of lever pressing for PPL-103 was consistent with rat pressing for saline - thereby demonstrating no euphoria (and likewise no dysphoria) whatsoever, even at supra-analgesic doses. These results are consistent with previous studies of PPL-103, including Conditioned Place Preference (CPP) / Conditioned Place Aversion (CPA) studies conducted by Stanford Research Institute (SRI). In those studies it was found that PPL-103 did not induce a significant CPP (euphoria) and demonstrated no CPA (dysphoria) whatsoever.

"Eliminating the incentive for abuse of pain drugs has to start with the underlying motivation," said Dr. John Lawson, Founder and CSO of Phoenix. "Any effective pain drug like PPL-103 that has no ability to generate euphoria in users is unlikely to support abuse and addiction. No patients in pain will later abuse such a drug if it doesn't produce a "high" in them", he said.

The leading opioids on the market today such as Morphine, Oxycodone, Hydrocodone, Methadone, Fentanyl, etc. bind to the mu receptor in the brain and then aggressively stimulate that receptor. But the Phoenix New Molecular Entity (NME) compounds bind strongly to all three opioid receptors (mu, kappa and delta) - and then just partially stimulate those receptors in a much more balanced manner. That partial stimulation derives potent analgesic benefit from all three receptors, but it is not sufficiently strong to produce the serious opioid side effects associated with any of the receptors. This profile results in first-ever opiate analgesics that appear to be non-addicting and free of all significant dangerous side effects.

Extensive animal efficacy studies of this family of opioids conducted by prominent scientists at leading institutions [2] also demonstrated the following:

  • Robust analgesic potency (10-20x stronger than morphine)
  • Oral bioavailability
  • Only moderate respiratory depression – even at 150x dose
  • No death from overdose - even at 350x the analgesic dose
  • No constipation – even at 100x dose (and very little even at 350x dose)
  • No physical dependence
  • No withdrawal symptoms

Also, the drugs did not precipitate withdrawal in dependent primates and therefore offer very promising use for addiction therapy as a preferred substitute for addictive opiates such as Methadone and Suboxone.

Recently Phoenix's drug family has also attracted attention for Animal Health applications, primarily due to the lack of respiratory depression and GI tract side effects as well as the likelihood that the drugs would likely be unscheduled (or at most scheduled in a low level class).

"We want to get PPL-103 into human clinical trials as quickly as possible. The predictive validity from animals to humans is quite high for opioids, and therefore we believe that there is a high probability that PPL-103 will be safe, effective and beneficial for humans." said Bill Crossman, CEO of Phoenix.

We will be attending Biotech Showcase 2016 in San Francisco. Here is a link to the Biotech Showcase Press Kit: http://biotechshowcase.vporoom.com/PhoenixPharmaLabs

Further information can be found on our website: www.phoenixpharmalabs.com

About Phoenix PharmaLabs

Phoenix PharmaLabs 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 opiate addiction. The strategic objective of the company is to enter into one or more license agreements with appropriate market leader(s) that have the resources and motivation to further develop, commercialize, and maximize the market potential of Phoenix's family of drugs. Phoenix is currently advancing its lead compound for pain through preclinical studies and then to proof of concept (POC) in humans. At or before that point is reached the company expects to license that compound to a pharma company that meets the criteria.

[1] O'Connor EC, Chapman K, Butler P, Mead AN (2011) The predictive validity of the rat self-administration model for abuse liability Neurosci Biobehav Rev. 35:912-938.

[2] Larry Toll and colleagues at SRI International and Torrey Pines Institute for Molecular Studies, Lou Harris and colleagues at Virginia Commonwealth University (VCU), and Jim Woods and colleagues at the University of Michigan

Company Contact:
Bill Crossman
860-305-6955
bill@phoenixpharmalabs.com

 

SOURCE Phoenix PharmaLabs, Inc.



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