Opioid Treatment Launches Proof-Of-Concept Study

TRV734 may have value as an alternative or complement to current treatments for opioid addiction treatments
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(Precision Vaccinations)

A Pennsylvania based biopharmaceutical company announced the initiation of a proof-of-concept study for TRV734, a novel mu-opioid receptor-selective agonist. 

Trevena, Inc. said in a press release published on December 23, 2019,  TRV734 is being evaluated as potential maintenance therapy for Opioid Use Disorder (OUD).

This is important news since opioids, mainly synthetic opioids, are currently the main driver of drug overdose fatalities. On average, 130 Americans die every day from an opioid overdose.

Trevena said it is providing TRV734 to National Institute on Drug Abuse (NIDA) Intramural Research Program scientists, who are conducting this new study. TRV734 is an investigational product not approved for distribution in the USA.

Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc., said in the press release, “A novel mu-opioid receptor-selective agonist such as TRV734, may have value as an alternative or complement to current treatments for opioid addiction, which is effective in some but not all people with opioid use disorder.”

Similar to current standard treatment options, TRV734 targets the mu receptor, but with an optimized mechanism of action that preferentially engages the signaling pathway responsible for therapeutic effect, with reduced activation of the signaling pathway responsible for mu receptor-mediated adverse effects. 

TRV734 is a new chemical entity (NCE) targeting the same novel mechanism of action as Trevena’s intravenous NCE, oliceridine, which selectively stimulates G-protein signaling at the mu-opioid receptor with low beta-arrestin recruitment.

TRV734 was designed to be orally available, and its mechanism of action suggests it may offer valuable benefits for two distinct areas of important unmet medical need: pain and management of opioid dependence associated with opioid use disorder. 

This study is a randomized, double-blind, four-period, placebo- and positive-controlled study that will enroll approximately 50 opioid-dependent patients undergoing stable methadone maintenance therapy.

The Department of Health and Human Services (HHS) has identified the development of effective treatment options as a top priority for addressing the ongoing opioid crisis.

The HHS has developed a 5-point comprehensive strategy

  • better data
  • better pain treatment
  • Increased addiction prevention, treatment, and recovery services
  • more overdose reversers
  • better research

Furthermore, HHS says Naloxone is an opioid antagonist that is used to temporarily reverse the effects of an opioid overdose, namely slowed or stopped breathing. Expanding the awareness and availability of this medication is a key part of the public health response to the opioid epidemic.

The states with the highest rates of death due to drug overdose were West Virginia, Ohio, and Pennsylvania. 

In an effort to expand access to Naloxone, Texas has become the first state to offer the life-saving overdose drug online in May 2019, freeing users of the stigma associated with drug use.

Furthermore, for the purpose of facilitating the prescribing of opioid antagonists to combat the effects of opioid overdose, the Texas Pharmacy Association (TPA) obtained a physician-signed standing order. 

This TPA standing order authorizes a pharmacist that is active and in good standing with the Texas State Board of Pharmacy to dispense an opioid antagonist in certain formulations.

And, a pharmacist may also dispense any other items necessary for the administration of opioid antagonists as determined by the Pharmacist, including, but not limited to, syringes and mucosal atomization devices.

Previously, opioid vaccines were initially proposed in the 1970s. 

Opioid vaccines are intended to elicit antibodies that block opioid distribution to the brain and reduce opioid-induced behavioral effects and toxicity. Most opioid candidate vaccines are currently viewed primarily as adjunctive to other treatment modalities.

Furthermore, because these vaccine candidates specifically target the opioid, rather than the opioid receptor, they should not interfere with OUD treatments or rescue drugs, such as methadone, buprenorphine, and naltrexone; and naloxone.

But, as of October 2019, the Food and Drug Administration has yet to approve any opioid vaccines for use, and clinical trials have thus far failed. 

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This new study is funded by the NIDA, part of the National Institutes of Health. 

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System disorders.

Opioid vaccine news published by Precision Vaccinations