Delving into the Latest Updates on ASP-8062 with Synapse

The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

Start Date13 Dec 2021

Sponsor / Collaborator

National Institute on Alcohol Abuse & Alcoholism

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NCT05062577 / WithdrawnPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder

The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone.

Start Date08 Nov 2021

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT04448561 / CompletedPhase 1

A Phase 1 Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants

The primary purpose of this study was to assess the safety and tolerability of multiple doses of ASP8062 or placebo alone and in combination with a single dose of morphine.
This study also assessed the potential for pharmacokinetic interaction between ASP8062 and morphine.

Start Date30 Jun 2020

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

[+1]

100 Clinical Results associated with ASP-8062

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100 Translational Medicine associated with ASP-8062

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100 Patents (Medical) associated with ASP-8062

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10

Literatures (Medical) associated with ASP-8062

16 Mar 2024·Alcohol and Alcoholism

Positive allosteric modulators of the GABAB receptor: a new class of ligands with therapeutic potential for alcohol use disorder

Review

Author: Colombo, Giancarlo

AbstractBackgroundPositive allosteric modulators (PAMs) of the GABAB receptor constitute a new class of GABAB-receptor ligands. GABAB PAMs reproduce several pharmacological effects of the orthosteric GABAB receptor agonist, baclofen, although displaying a better safety profile.AimsThis paper reviews the reducing or, frequently, even suppressing effects of all GABAB PAMs tested to date on multiple alcohol-related behaviours in laboratory rodents exposed to validated experimental models of human alcohol use disorder.ResultsAcute or repeated treatment with CGP7930, GS39783, BHF177, rac-BHFF, ADX71441, CMPPE, COR659, ASP8062, KK-92A, and ORM-27669 reduced excessive alcohol drinking, relapse- and binge-like drinking, operant alcohol self-administration, reinstatement of alcohol seeking, and alcohol-induced conditioned place preference in rats and mice.ConclusionsThese effects closely mirrored those of baclofen; notably, they were associated to remarkably lower levels of tolerance and toxicity. The recent transition of ASP8062 to clinical testing will soon prove whether these highly consistent preclinical data translate to AUD patients.

01 May 2023·Journal of Psychopharmacology

A phase 1 randomized, placebo-controlled study to investigate potential interactions between ASP8062, a positive allosteric modulator of the GABA_B receptor, and morphine in recreational opioid users

Article

Author: Erdman, Jay ; Blauwet, Mary Beth ; Kelsh, Debra ; Walzer, Mark ; Alsharif, Mohamad Nour ; Heo, Nakyo ; Spence, Anna ; Blahunka, Paul ; Marek, Gerard J ; Ito, Mototsugu

Background: Recent increases in opioid use and subsequent opioid use disorder are a major public health crisis in the United States. Aims: This phase 1 randomized, placebo-controlled study investigated the safety, tolerability, and pharmacokinetics (PKs) of ASP8062, a γ-aminobutyric acid B receptor-positive allosteric modulator, with and without administration of morphine in participants who used opioids recreationally. Methods: Participants were randomly assigned (2:1) to daily dosing with ASP8062 25 mg or placebo on days 1–10. On day 10, all participants received morphine as a single oral dose of 45 mg; assessments were performed on days 11–16. The primary end point was safety, evaluated as the nature, frequency, and severity of adverse events, and end-tidal CO2 levels. PK end points were a secondary outcome measure. Results: A total of 24 participants (aged 21–54 years) received ASP8062 ( n = 16) or placebo ( n = 8). There were no deaths or serious adverse events leading to treatment discontinuation during the study. Most adverse events were mild, with numerically lower absolute number of adverse events reported with ASP8062 plus morphine versus placebo plus morphine. ASP8062 plus morphine did not increase respiratory depression, potential drug abuse- or withdrawal-related adverse events. There were no significant PK interactions. Conclusions: In this phase 1 study, we did not observe any unexpected safety signals or notable PK interactions with concomitant morphine administration. These data suggest a potentially low risk for an increase in drug abuse- or withdrawal-related adverse events or respiratory distress in participants exposed to ASP8062 and morphine.

01 Apr 2023·Journal of Pharmacological Sciences

Effect of ASP8062 on morphine self-administration and morphine-induced respiratory suppression in monkeys

Article

Author: Irie, Megumi ; Sato, Yuichiro ; Shirakawa, Takafumi ; Kanki, Masayuki ; Akuzawa, Shinobu

ASP8062 is an orally available GABA_B receptor positive allosteric modulator (PAM). This study assessed the potential of ASP8062 for treating opioid use disorder (OUD). Three rhesus monkeys were pretreated with ASP8062 (0.3, 1 or 3 mg/kg) by oral administration 1 h prior to a 2-h morphine self-administration session (0.03 mg/kg, iv, per injection) under a fixed-ratio 5 schedule. We further examined the potential worsening of morphine-induced respiratory suppression by ASP8062 after coadministration of morphine (10 mg/kg, sc) and ASP8062 (10 mg/kg, po) in cynomolgus monkeys using a custom-made whole-body plethysmograph. Plasma concentrations of ASP8062 (3 or 10 mg/kg, po) were assessed in cynomolgus monkeys using liquid chromatography-tandem mass spectroscopy (LC-MS/MS). ASP8062 at 3 mg/kg, po decreased the morphine self-administrations with significant differences from the vehicle-treated group (IC₅₀ = 0.97 ± 0.36 mg/kg). Exposure levels at 3 mg/kg observed in monkeys were comparable to the clinical exposure levels which positive pharmacodynamic effects were previously shown. Further, ASP8062 did not potentiate morphine-induced respiratory suppression up to exposure levels higher than the clinically relevant dose. ASP8062 may reduce opioid use in OUD patients without affecting respiratory system, providing justification for further ASP8062 development as a potential treatment option for OUD.

100 Deals associated with ASP-8062

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alcohol Use Disorder	Phase 2	US	Astellas Pharma, Inc.	13 Dec 2021
Opioid abuse	Phase 2	-	Astellas Pharma Global Development, Inc.	08 Nov 2021
Opioid-Related Disorders	Phase 2	US	Astellas Pharma, Inc.	14 Apr 2021
Opioid abuse	Preclinical	-	Astellas Pharma Global Development, Inc.	08 Nov 2021
Opioid-Related Disorders	Preclinical	US	Astellas Pharma, Inc.	14 Apr 2021
Fibromyalgia	Preclinical	US	Astellas Pharma Global Development, Inc.	08 May 2017

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Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04447287 (CTgov)	Phase 1	Opioid abuse	23	buprenorphine/naloxone+ASP8062 (ASP8062 in Combination With Buprenorphine/Naloxone)	jvkroloxdg(xgpdrntmkf) = phxtmpuzyb qcpnmnemiu (tacmnmeeat, qyrgwmhvsl - iqcozmhsmk) View more	-	12 Jan 2022
				Placebo ASP8062+buprenorphine/naloxone (Placebo ASP8062 in Combination With Buprenorphine/Naloxone)	yxqxwifsws(lgerbhhpdo) = eypaijkgdd oxzdlyidlr (kvzwfppdsl, ymrcnbavoh - tehedsjzeg) View more
NCT04448561 (CTgov)	Phase 1	Opioid abuse	24	morphine+ASP8082 (ASP8062 in Combination With Morphine)	(szmikqyeva) = ldqxrnblsu uknzivubmj (hfgmcopyco, ybviqazqmf - mutjsannhi) View more	-	29 Sep 2021
				Placebo+morphine (Placebo in Combination With Morphine)	(szmikqyeva) = rqwxblfutr uknzivubmj (hfgmcopyco, xqthmdzwde - oyghznaubi) View more
NCT03092726 (CTgov)	Phase 2	Fibromyalgia	183	Placebo (Placebo)	ffhoeipubb(qxjygfebjp) = zwqyyficdd cqgwpnutml (bohayfabte, bccbomcffa - uhpddcidvk) View more	-	28 Mar 2019
				ASP8062 (ASP8062)	ffhoeipubb(qxjygfebjp) = sidsxfjsgu cqgwpnutml (bohayfabte, mufifixuit - azicqnixwc) View more