CORALVILLE, Iowa, Sept. 8, 2015 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced today that four posters related to the development of its investigational prodrug of hydrocodone (KP201), combined with acetaminophen (APAP), together referred to as KP201/APAP, will be presented at the PAINWeek 2015 Annual Meeting, September 8-12, 2015, in Las Vegas, Nevada. KP201/APAP is being developed to provide clinicians and patients a novel, abuse-deterrent, immediate release prodrug of hydrocodone/APAP, the most commonly prescribed opioid in the United States.
The four poster presentations at PAINWeek 2015 describe data on the abuse-deterrent and tamper resistant properties of KP201/APAP, the potential of prodrugs for creating abuse-deterrent analgesics, and the abuse prevalence and patterns of abuse for hydrocodone combination products. KemPharm plans to include information from these studies in its New Drug Application (NDA) for KP201/APAP that the Company plans to file with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2015.
Travis C. Mickle, Ph.D., President and CEO of KemPharm, stated, "The studies being presented at PAINWeek 2015 shed light on several compelling issues with respect to lifetime opioid abusers, methods of abuse, and the value that prodrugs, and KP201/APAP in particular, may offer in potentially limiting the abuse of prescription opioids. Several of the studies described in the posters have already been reviewed by the FDA at our pre-NDA meeting and we have received positive feedback regarding abuse patterns of current hydrocodone/APAP products and how KP201 may be able to address this issue."
In a poster titled, "Patterns of abuse of hydrocodone combination products: Results from an Internet survey of recreational drug users" (Poster Board #27), by Theresa Cassidy, MPH; Natasha K. Oyedele, MPH; Jared Beaumont; MPH; and Stephen Butler, Ph.D., all of Inflexxion, Inc., will report data from a survey aimed gaining a better understanding of the patterns and characteristics of abuse among those who report use of hydrocodone combination products (HCPs). The survey revealed that approximately 62% of the 304 respondents indicated that HCPs were the first prescription opioid used in their lifetime, and almost 52% indicated their first use was non-medical and occurred primarily between 14 and 18 years old at first use. Additionally, among the lifetime HCP users (n=288), approximately 60% (n=175) were former HCP users, of which 16% (n=28) moved on to more potent prescription opioids to get a better quality high. This may indicate that these products serve as a gateway drug for some lifetime HCP users who start to progress to greater levels of substance abuse behaviors.
Cassidy and Butler will also present with Eileen Thorley, MPH, and Taryn Dailey, MPH, both of Inflexxion, a second poster, titled, "Abuse prevalence and patterns for immediate-release hydrocodone combination products" (Poster Board #26). This poster will highlight results from an analysis of more than 150,000 high-risk adults assessed for substance abuse treatment at centers throughout the United States during January 2012 through September 2014 using data collected from the Addiction Severity Index – Multimedia Version. This time period was selected to evaluate abuse of HCPs prior to rescheduling. Data from this high-risk population indicate abuse of HCPs impacts a large number of prescription opioid abusers who demonstrate a level of severity as either considerable or extreme in their abuse behavior. For instance, in absolute numbers, snorting of HCPs is similar to other prescription opioids typically reported with high levels of snorting while oral abuse is the most frequent route of administration for HCPs.
In a poster titled, "New Pain Therapies with Low Inherent Abuse Potential: Are Prodrugs an Answer to the Opioid Abuse Epidemic? A Review" (Poster Board #84), Srinivas Nalamachu, M.D., President and Medical Director, International Clinical Research Inst., Overland Park, KS, and Jeffrey Gudin, M.D., Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center, Englewood, NJ, will present research suggesting that prodrug formulations have great potential for creating abuse-deterrent analgesics as they can be inherently tamper-resistant without the need of special formulations. This may result in abuse reduction as evidenced by data showing a reduction in abuse with Vyvanse®, an inactive prodrug of the parent drug dextroamphetmine. Additionally, the findings confirm that prodrugs only activated in the digestive tract should be expected to have low bioavailability if administered intravenously or intranasally. Further, if the activation system can be saturated, the oral bioavailability at high doses could be limited, possibly conferring some overdose protection. Although, this study also indicates that, like all abuse-deterrent analgesics, prodrug formulations will require post-marketing studies to determine whether they result in meaningful reductions of abuse, misuse and related adverse clinical outcomes, including addiction, overdose and death in the post-approval setting.
Dr. Nalamachu and Dr. Gudin will also present a second poster, titled, "The Pharmacokinetics, Bioavailability, Abuse-Deterrent and Tamper-Resistant Properties of KP201/APAP, a Combination Opioid Pain Reliever Containing a Hydrocodone-Based Prodrug, A Review" (Poster Board #85). The poster reviews a series of studies related to KP201/APAP. The study results show that KP201/APAP not only demonstrates abuse-deterrent and tamper resistant properties, but is bioequivalent to Norco®, an immediate-release hydrocodone bitartrate/APAP combination product. Additionally, the study results indicate that KP201 is poorly water soluble, and extraction yields only inactive prodrug. Further, these study results also show that KP201 appears chemically stable and likely only hydrolyzes and/or decomposes only under harsh conditions.
The abstracts for each poster are available on PAINWeek 2015's website at www.painweek.org. The posters will be available for viewing at the PAINWeek Poster Session and Reception being held Thursday, September 10, 2015, from 7:00 p.m. to 9:00 p.m. local time.
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology. KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other CNS disorders.
Caution Concerning Forward Looking Statements
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21 E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as "may," "will," "expect," "project," "estimate," "anticipate," "plan," "believe," "potential," "should," "continue" or the negative versions of those words or other comparable words. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to the Company and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by the Company's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm's business are described in additional detail in the Company's Registration Statement on Form S-1 (Registration No. 333-202660) declared effective April 15, 2015, and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
|For KemPharm, Inc.:||Media / Investor Contacts:|
|Gordon K. "Rusty" Johnson||Jason Rando / Joshua Drumm, Ph.D.|
|319-665-2575||Tiberend Strategic Advisors, Inc.|
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