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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), 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

[+1]

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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11

Literatures (Medical) associated with ASP-8062

01 Dec 2024·Alcohol, Clinical and Experimental Research

Effects of a novel GABA‐B positive allosteric modulator, ASP8062, on alcohol cue‐elicited craving and naturalistic alcohol consumption in a multisite randomized, double‐blind, placebo‐controlled trial

Article

Author: Ryan, Megan L. ; Litten, Raye Z. ; Chun, Thomas ; Alsharif, Nour ; Ransom, Janet ; Falk, Daniel E. ; Schacht, Joseph P. ; Ito, Mototsugu ; Miranda, Robert ; Scott, Charles ; Miotto, Karen ; Ray, Lara A. ; Sakai, Joseph T.

Abstract:

Background:

The γ‐aminobutyric acid‐B (GABAB) receptor is a promising target for the development of new medications to treat alcohol use disorder (AUD). The GABAB agonist baclofen has been reported to reduce alcohol consumption but is associated with some undesirable side effects, including sedation. ASP8062 is a novel compound that acts as a positive allosteric modulator at the GABAB receptor and may be more tolerable than baclofen. This proof‐of‐concept human laboratory clinical trial evaluated the safety profile of ASP8062 and tested its effects on cue‐elicited alcohol craving and alcohol use among treatment‐seeking individuals with AUD.

Methods:

This double‐blind, randomized, multisite trial tested the effect of ASP8062 (25 mg once daily), relative to placebo, on alcohol cue‐elicited craving in a laboratory setting and alcohol consumption, craving, mood, sleep, cigarette smoking, and alcohol‐related consequences in the natural environment over a 6‐week treatment period. Participants were 60 individuals (26 females and 34 males) with moderate or severe AUD.

Results:

ASP8062, relative to placebo, was well tolerated, and there were no adverse events (AEs) that significantly differed between treatment groups. Most AEs were mild/moderate, and there were no serious AEs among individuals treated with ASP8062. However, ASP8062 did not attenuate alcohol cue‐elicited craving compared with placebo. Moreover, exploratory analyses indicated that ASP8062, relative to placebo, did not significantly affect alcohol consumption, naturalistic alcohol craving, mood, sleep, cigarette smoking, or alcohol‐related negative consequences during the 6‐week treatment period.

Conclusions:

Although ASP8062 was well tolerated with no serious AEs, the novel compound did not significantly dampen alcohol cue‐elicited craving or improve other AUD‐related outcome measures. These data indicate positive allosteric modulation of the GABAB receptor at the dose evaluated here may not blunt alcohol cue‐elicited craving, and preliminary drinking outcome data suggest it may not be an efficacious treatment strategy for AUD.

16 Mar 2024·Alcohol and alcoholism (Oxford, Oxfordshire)

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

Review

Author: Colombo, Giancarlo

Abstract:

Background:

Positive 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.

Aims:

This 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.

Results:

Acute 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.

Conclusions:

These 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 (Oxford, England)

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

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.

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	United States	Astellas Pharma, Inc.	13 Dec 2021
Opioid abuse	Phase 2	-	Astellas Pharma Global Development, Inc.	08 Nov 2021
Opioid-Related Disorders	Phase 2	United States	Astellas Pharma, Inc.	14 Apr 2021
Fibromyalgia	Phase 2	United States	Astellas Pharma Global Development, Inc.	08 May 2017

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05096117 (CTgov)	Phase 2	Alcohol Use Disorder	60	ASP8062 (ASP8062 (25 mg Once Daily))	fiboxiincr(ruiqhfduvb) = fxdtafakzn utftwilyir (suzjwpqqqb, 1.09) View more	-	03 Dec 2024
				Placebo (Matching Placebo)	fiboxiincr(ruiqhfduvb) = mhdrigdpek utftwilyir (suzjwpqqqb, 1.13) View more
NCT04447287 (CTgov)	Phase 1	Opioid-Related Disorders \| Opioid abuse	23	buprenorphine/naloxone+ASP8062 (ASP8062 in Combination With Buprenorphine/Naloxone)	xohlxxdorl(glntykhuxf) = pijgasfyoc oorwcezuez (efimpddsto, 1750) View more	-	12 Jan 2022
				Placebo ASP8062+buprenorphine/naloxone (Placebo ASP8062 in Combination With Buprenorphine/Naloxone)	wnrgxzyiso(msfwibdzyz) = okslwijeeh iektfixufz (ofmxvqbtbq, 18700) View more
NCT04448561 (CTgov)	Phase 1	Opioid abuse	24	morphine+ASP8082 (ASP8062 in Combination With Morphine)	sbbhzucftj = iaamydswis toncwdtwtc (gocjewyvuk, mpscctxlaj - ebjvaqjhuz) View more	-	29 Sep 2021
				Placebo+morphine (Placebo in Combination With Morphine)	sbbhzucftj = ilvfoypuhd toncwdtwtc (gocjewyvuk, lgpegssjip - svfwdntfhp) View more
NCT03092726 (CTgov)	Phase 2	Fibromyalgia	183	Placebo (Placebo)	nbeclkyuth(zazzfzwurq) = hhydjemfuz cqqonftsjd (uoecommjcg, 0.19) View more	-	28 Mar 2019
				ASP8062 (ASP8062)	nbeclkyuth(zazzfzwurq) = jhqnrwsfbd cqqonftsjd (uoecommjcg, 0.19) View more