Navigation Links
ADial Pharmaceuticals Announces Agreement With FDA For Phase III Trial Of AD04 For Alcohol Use Disorder In Patients Of Targeted Genotypes
Date:4/18/2013

CHARLOTTESVILLE, Va., April 18, 2013 /PRNewswire/ -- ADial Pharmaceuticals, LLC ("ADial"), announced today that the U.S. Food and Drug Administration ("FDA") has agreed to allow ADial to move forward with its plan to initiate Phase III trials of AD04 as a treatment for alcohol use disorder ("AUD") in certain targeted genotypes population only. Patients will initially be screened for the targeted genotypes and only those with one or more of the targeted genotypes will be enrolled in the trial. Enrolled patients will then be randomized between the active drug and placebo. Performing the Phase III trial in only the targeted genotypes significantly reduces the trial size and associated costs and risk of the trial.

The two endpoints for demonstrating the efficacy of AD04 in the trial are percent of heavy drinking days ("PHDD") and the percent of subjects with no heavy drinking days ("PSNHDD") in the final two months of the trial. For both endpoints, a heavy drinking day is defined as a day with 4 or more drinks for women or 5 or more drinks for men. The European Medicines Authority ("EMA") has accepted PHDD as a primary endpoint for approval of drugs for the treatment of alcohol dependence and the FDA has stated that PSNHDD is an acceptable endpoint for demonstrating efficacy of AD04 in the US.

Two successful Phase III trials will be required for approval of AD04. Each trial will be 24 weeks in duration and will enroll approximately 600 patients.

"The ability to launch the Phase III trials only in subjects having the targeted genotypes represents an important breakthrough for the Company and for this promising new therapy for Alcohol Use Disorder," said William Stilley , Chief Executive Officer. "Planning is underway to commence Phase III trials later this year."

Alcohol Use Disorder (AUD)

According to the National Institute of Alcohol Abuse and Alcoholism ("NIAAA"), as many as 42 million people in the U.S. alone are afflicted by an alcohol disorder. The Centers for Disease Control ("CDC") has reported that alcohol disorders cost the U.S. economy more than $200 billion annually, with heavy drinking accounting for greater than 75% of the social and health related costs. Despite this, fewer than 5% of patients with AUD are estimated to have been diagnosed and significantly fewer receive meaningful treatment. AUD is characterized by an urge to consume alcohol and an inability to control the levels of consumption. Both acute and chronic consumption of high levels of alcohol are associated with negative social and health consequences. In the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) being published in May 2013, AUD replaces the disease states previously defined as alcohol abuse and alcohol dependence.

About AD04

AD04 is being developed as a treatment for alcohol use disorder in patients of select genotypes. AD04 is a serotonin-3 (5HT3) antagonist that is believed to interrupt the reinforcing effects of alcohol, and thus reduces the urge to drink. Such reinforcing effects are thought to be exaggerated in patients that have certain mutations of the genes that control serotonin function in the brain, and these are the patients targeted for treatment with AD04. AD04 contains an ultra-low dose of the active ingredient ondansetron, which is currently marketed as an anti-emetic for post-operative and post-chemotherapy nausea. Doses effective for treating alcohol addiction are well below those used to treat emesis. Clinical and non-clinical experience to date suggest that higher doses like those used for the treatment of emesis may have reduced efficacy for treating addiction and additional safety risks associated with their chronic use as would be required for treatment of addiction.

ADial has patents covering the use of ondansetron in patients with the targeted genotypes for addictions, including alcohol, obesity, and cocaine. Phase II clinical study results of AD04 for AUD have been published in the American Journal of Psychiatry and the Journal of the American Medical Association.

About ADial Pharmaceuticals, LLC

ADial Pharmaceuticals is a privately held pharmaceutical company developing medications for treating addiction diseases and disorders, including alcohol and drug addictions (cocaine, opioids, methamphetamines), as well as other addiction-like behaviors such as those related to obesity and eating disorders. The company's most advanced compound, AD04, specifically targets alcohol use disorder (previously called alcohol abuse and dependence) in patients with selected genotypes. For more information, visit http://www.adialpharma.com.


'/>"/>
SOURCE ADial Pharmaceuticals, LLC
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
2. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
3. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
4. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
5. Icahn Issues Statement Regarding Amylin Pharmaceuticals
6. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
7. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
8. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
9. Jazz Pharmaceuticals Announces First Quarter 2012 Financial Results Conference Call On May 8, 2012
10. Inovio Pharmaceuticals Granted U.S. Patent Protection for Synthetic Vaccine for Cervical Dysplasia and Cancer
11. Avanir Pharmaceuticals To Present at Three Conferences In May
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... Research and Markets has announced the addition of the "Global ... - Forecast to 2025" report to their offering. ... , , ... a CAGR of around 3.2% from 2015 to 2025. Some of ... extracellular microelectrode arrays and intracellular microelectrodes, research in left-to-right shunt detection ...
(Date:12/8/2016)... , Dec. 8, 2016  Valeant Pharmaceuticals ... TSX: VRX) ("Valeant") today announced positive results from ... study to assess the safety and efficacy of ... treatment of plaque psoriasis. Within ... with moderate to severe psoriasis, IDP-118 showed statistical ...
(Date:12/8/2016)... , 8. Dezember 2016 Mederi Therapeutics Inc . hat die ... nicht-operative Behandlungsmethode für gastroösophageale Refluxerkrankung (GERD) – in China ... ... Live Stretta procedure performed ... Liu, Director of Endoscopy at Wuhan Union Hospital ...
Breaking Medicine Technology:
(Date:12/7/2016)... ... 07, 2016 , ... Students attending Envision’s summer 2017 ... get hands-on experience in an emergency medical simulation, When Care is Hours Away. ... real-life medical skills that are critical success in a future career and beyond. ...
(Date:12/7/2016)... ... December 07, 2016 , ... Kenall Manufacturing, a leader in sealed healthcare ... The MPCNGX is a multi-function, sealed, LED luminaire that meets the needs of everyone ... when it’s needed. , A 2’ x 4’ model features four modes: ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... wrinkles and deep lines by smoothing and tightening the skin of the face ... there to address facial aging with very little downtime, Silhouette Instalift is a ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... up with a schizophrenic mother in a unique, personal perspective through animation. ... treating trauma and addictive disorders at her private psychotherapy practice. Sheri’s mother, Pearl, ...
(Date:12/7/2016)... ... ... In the early morning of October 30, Newton County Sheriff’s Deputy Justin ... control of his patrol car. The vehicle overturned into an embankment, causing White to ... Medical Center, where he later succumbed to his injuries. Justin White leaves behind his ...
Breaking Medicine News(10 mins):