Navigation Links
Abuse Deterrent Hydrocodone / Acetaminophen Leads NDA Pipeline
Date:1/19/2011

PISGAH FOREST, N.C., Jan. 19, 2011 /PRNewswire/ -- As Pisgah Laboratories, Inc. continues development of its lead abuse deterrent opioid product, it will soon begin scale-up of its patent-pending form of hydrocodone. Pisgah has developed a specialized salt form of hydrocodone which imparts abuse deterrent properties to a dosage product. Pisgah will manufacture its hydrocodone salt for clinical trials in their FDA / DEA registered facility. Accordingly, Pisgah's pilot plant has recently undergone appropriate modifications to convert the often, and readily abused, hydrocodone bitartrate currently used by the pharmaceutical industry to Pisgah's abuse deterrent form. Pisgah's approach to the abuse epidemic thwarts attempts by potential abusers to de-formulate hydrocodone products for abuse purposes.

Typically, abusers extract the active ingredient from a formulated dosage product. The principal extraction procedure popularly employed by hydrocodone abusers is the "cold water method." The abuser grinds up the hydrocodone bitartrate / acetaminophen combination tablets and extracts them with a minimum amount of cold water to separate the insoluble and potentially toxic acetaminophen (APAP) from the water soluble hydrocodone bitartrate. The abuser then drinks the water extract and experiences a "high" or "rush." In contrast, Pisgah's hydrocodone salt is not amenable to such an extraction procedure and thus defeats the abusers' attempt to isolate the narcotic component from the dosage product.

Pisgah recently completed an alternate species animal study comparing inhalation properties of hydrocodone bitartrate with their abuse deterrent hydrocodone. The pharmacokinetic study clearly differentiated the two forms thus validating Pisgah's approach in defeating nasal abuse of hydrocodone. Similarly, the study results also confirm proper oral administration allows for the drug to work as intended. These results, coupled with the extraction protection available through Pisgah's technology, provide the first practical solution to hydrocodone drug abuse.

Pisgah's product development program is now focused on clinical trial production. Since hydrocodone is principally used in combination products with other actives such as acetaminophen, Pisgah has selected dosage strengths of hydrocodone / APAP meeting the FDA's new limits for acetaminophen, http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm, and comparable to existing commercial products so that side-by-side abuse deterrent comparisons can be performed. One study in particular, called a likability study, will be performed using known "recreational" users. From results to date, these users will predictably find Pisgah's hydrocodone "un-likable." Indeed, inhalation or other abuse routes of administration -- such as application to the mucosa -- will not yield the desired "high."

Pisgah Laboratories continues to file patent applications covering the broad applicability of their technology to hydrocodone as well as to other narcotic products. At last count, fourteen applications were in various states of prosecution before the US Patent and Trademark Office covering opioids, anti-depressants and the ADHD medications dex-amphetamine and methylphenidate. While hydrocodone has advanced from the laboratory into the development stage, other abuse deterrent products will soon follow an identical and established development template.  

Pisgah's technology provides an integrated approach to solving three principal concerns within the medical community: 1) improving patient care; 2) reducing medical practice liability; and 3) reducing barriers for treating pain. Clearly, abuse deterrent products improve the health of the nation's population by reducing drug abuse. Secondly, the regulatory initiatives to reduce abuse impose liability on the medical community requiring identification and mitigation of patient drug abuse. Without exception, these well-intended actions erect barriers to pain treatment for legitimate patients and enhance the perceived liability of doctors. Pisgah anticipates its new products will be well-received by all stakeholders interested in reducing the nation's drug abuse epidemic.            

For more information on Pisgah's pipeline, visit http://www.pisgahlabs.com or call Todd Stamps, Business and Market Development, 803-212-8224.

This press release was issued through eReleases(R).  For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.


'/>"/>
SOURCE Pisgah Labs, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Fuisz Pharma Releases Clinical Photos of Its Opioid Abuse Detection System
2. IIP Recognition for Substance Abuse Testing Lab Trimega Laboratories
3. Abuse Of Prescription Meds Among Teens Greater Than Most Illegal Drugs
4. Opioid Education Lags as Abuse Climbs
5. National Survey of Physicians Reveals Common Misperceptions Concerning Misuse and Abuse of Opioids in Light of New Government Statistics
6. Survey of Police and Teachers: Alcohol and Marijuana Most Serious Substance Abuse Facing Teens
7. FDA CONSUMER HEALTH INFORMATION - Combating Misuse and Abuse of Prescription Drugs: Q&A with Michael Klein, Ph.D.
8. Fuisz Pharma Announces Acquisition of Key Anti Opiate Abuse Patent to Complement its Anti Opiate Abuse Platform
9. Partnership for a Drug-Free Americas 21st Annual Teen Survey Shows No Significant Increase in Over-the-Counter Medicine Abuse Rates
10. World-Leading Alcohol Abuse Lab Status for Trimega
11. Omeros Announces National Institute on Drug Abuses Support for Phase 2 Clinical Study in Addiction Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
(Date:6/23/2016)... -- Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in ... . ... ... ... Astellas is ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
(Date:6/24/2016)... ... 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida ... their peers for this recognition are considered among the top 2 percent of lawyers ... as members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark ...
(Date:6/24/2016)... ... ... Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair ... hour by 2020 and then adjusting it yearly to increase at the same rate as ... the wage floor does not erode again, and make future increases more predictable. , The ...
Breaking Medicine News(10 mins):