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06-01-2016
Phoenix PharmaLabs Releases New Data Confirming That Their Novel Opioid Shows No Signs of Addiction Potential

 

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

 

Salt Lake City, January 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


08-04-2015
Novel Pinkiller with Little or No Signs of Addiction and Other Serious Opioid Side Effects Patented by Phoenix PharmaLabs

 

Novel Painkiller with Little or No Signs of Addiction and Other Serious Opioid Side Effects Patented by Phoenix PharmaLabs

 

Salt Lake City, April 8, 2015 /PRNewswire/ -- Phoenix PharmaLabs, Inc. (“Phoenix”), announced today that the United States Patent Office issued a Composition patent on March 24, 2015 for the Company’s advanced analog known as PPL-103 that belongs to a unique new class of opioids for the treatment of pain as well as opioid addiction.

 

The leading potent opioid analgesics in use today such as Morphine, Oxycodone, Hydrocodone, Methadone, Fentanyl, etc. bind strongly to the mu receptor in the brain and then aggressively agonize that receptor, leading to a number of severe side effects. However, Phoenix has developed a novel family of New Molecular Entity (NME) opioids that have high binding affinity at all three opiate receptors: mu, kappa and delta.  These unique ligands have more balanced receptor activity than morphine and other opioids, with partial activity at mu, somewhat higher, but not full, kappa activity, and moderate delta activity. Thus, PPL-103 derives potent analgesia primarily from mu and kappa, but does not stimulate those receptors so intensely that they trigger the negative side effects of either receptor.  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 [1] demonstrated the following:

 

  • Robust analgesic potency (10-20x stronger than morphine)
  • Little or no euphoric reward (which leads to abuse and addiction)
  • No dysphoria
  • No death from overdose - even at 350x the analgesic dose
  • No constipation – even at 100x dose

 

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.

 

“Eliminating the incentive for pain drug abuse 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 (or at least substantially reduced) 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. Further, PPL-103 has shown that it produces only moderate levels of respiratory depression at highly elevated dosages (150x analgesic dose). “The ability to deliver high-quality pain relief without the threat of death from respiratory depression alone is a major improvement over existing available therapies.” said Bill Crossman, CEO of Phoenix.

 

Recent focus on abuse-deterrent formulations (ADFs):

Recently the focus of pharma companies has been to attempt to reduce opioid abuse and addiction through the development and promotion of extended-release (ER) and/or abuse-deterrent formulations (ADFs). But drug seekers have been reported to actually prefer the ER formulations because tampering with these products provides them with a higher maximum concentration of the drug, and while ADFs can discourage abuse, the drugs are still addicting and they can still be abused. In fact, black-market methods to circumvent some leading ADFs can be found right online. [2] “While the various ADF strategies are helpful, they are really just attacking the abuse and addiction problem from the periphery, whereas Phoenix’s technology goes directly to the core solution to the problem.” said Crossman. “If ADFs are deemed to be a beneficial strategy then why not use those strategies in combination with an Active Pharmaceutical Ingredient (API) like PPL-103 instead of highly addictive opiates like morphine, oxycodone or hydrocodone?”

 

“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 Crossman.

 

[1] 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

 

[2] Fudin J Abuse-Deterrent Opioid Formulations: Purpose, Practicality, and Paradigms [internet]. 2015. [Accessed 2015 March 24]. Available from: http://www.pharmacytimes.com/contributor/jeffrey-fudin/2015/01/abuse-deterrent-opioid-formulations-purpose-practicality-and-paradigms

 

Company Information and Contact:

 

www.phoenixpharmalabs.com

 

Bill Crossman

860-305-6955

bill@phoenixpharmalabs.com


02-23-2011
Patent Awarded
"Use of PPL opiate in the treatment of opiate addiction."

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

 

Phoenix PharmaLabs Releases New Data Confirming That Their <...
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Novel Pinkiller with Little or No Signs of Addiction and Other Serious Opioid Side Effects Patented by Phoenix PharmaLabs

 

Novel Painkiller with Little or No Signs of Addiction and Other Serious Opioi...
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Patent Awarded
"Use of PPL opiate in the treatment of opiate addiction." ...
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