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KemPharm (KMPH) Announces Publication Of Study Of Intranasal Abuse Of Hydrocodone Combination Products In Pharmacoepidemiology & Drug Safety



8/8/2017 8:48:21 AM

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Study Confirms Intranasal Abuse of Hydrocodone/Acetaminophen by Adolescents & Adults may be a
Significant Public Health Issue

CORALVILLE, Iowa, Aug. 08, 2017 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced the publication of the results from a study conducted by Inflexxion, Inc. evaluating the patterns of abuse and how immediate-release hydrocodone acetaminophen combination products are administrated in the peer-reviewed journal Pharmacoepidemiology & Drug Safety.

Titled “Patterns of Abuse and Routes of Administration for Immediate-Release Hydrocodone Combination Products,” by Cassidy, et al., the peer reviewed manuscript examined prevalence of abuse of immediate-release (IR) hydrocodone combination products as compared to other classes of opioids. While prescriptions for hydrocodone combination products have recently decreased, they remain the most widely prescribed opioid products in the United States and are subject to frequent abuse among adults and adolescents. Few data existed to understand the contribution of IR products to the problem of prescription opioid abuse. This epidemiological study sought to better understand abuse patterns for IR hydrocodone combination products among adult and adolescent substance abusers.

“Our findings suggest that frequently prescribed opioids, such as hydrocodone IR combination products, may contribute substantially to the overall problem of prescription opioid abuse,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm and co-author. “The data from this study of the epidemiology of abuse of opioids in the United States confirm a prevalence of intranasal (IN) abuse of IR hydrocodone combination products among about 23% of adults and 43% of adolescents assessed for substance abuse treatment in the sampled from the Addiction Severity Index – Multimedia Version/ Comprehensive Health Assessment for Teens (ASI-MV/CHAT) database. Considering that hydrocodone is the most widely prescribed opioid in the US, these figures translate into a large absolute number of individuals abusing these products intranasally. KemPharm believes this represents a significant public health risk that requires a multimodal mitigation approach, including abuse deterrent technologies.”

“This result adds important substance to the general understanding of IN abuse of hydrocodone/ acetaminophen products among adolescents and adults who misuse prescription opioids,” added Theresa Cassidy, Ph.D., Vice President of Health Analytics at Inflexxion and lead author of the study. “Our study showed in absolute terms, given the approximately 90 million prescriptions issued as recently as 2015, IN abuse of these relatively easily available opioid products equaled or exceeded the abuse of extended release opioid products.”

Study Design & Results

A cross-sectional study examined abuse prevalence (including abuse adjusted for prescription volume and morphine milligram equivalents) and abuse characteristics for IR hydrocodone combination products and other prescription opioids among separate samples of adults and adolescents assessed for substance abuse problems or entering treatment from January 2012 through June 2015.

Results indicated higher abuse for IR hydrocodone combination products than other opioid categories per 100 assessments but lower per prescriptions dispensed. IR hydrocodone combination products had similar abuse prevalence to all extended-release and long-acting opioids when considering abuse measured per morphine milligram equivalents dispensed. An upward trend in IR hydrocodone combination product abuse was observed among adult substance abusers comparing the period prior to and after Drug Enforcement Administration rescheduling from Schedule III to Schedule II of these products in October 2014.

Most individuals reported oral abuse of IR hydrocodone combination products, but snorting, reported by 23% of hydrocodone IR combination product abusers, also appears to be a route of abuse that may have public health relevance.

About KemPharm

KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its LAT™ (Ligand Activated Therapy) 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 central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of methylphenidate, but with differing extended-release profiles for the treatment of ADHD, and KP201/IR, an acetaminophen-free formulation of the company’s immediate release abuse deterrent hydrocodone product candidate, KP201. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com.

About Inflexxion

Inflexxion helps healthcare organizations, provider communities, pharmaceutical companies, and regulatory authorities to improve patient care and inform public policy. Through their strategic approach and depth of expertise, Inflexxion analyzes and disseminates health-related data for surveillance, risk management, epidemiological studies, quality improvement, and outcome measurement. Inflexxion’s unique data collection includes multiple data streams at the point-of-care, Internet Monitoring technology, and web-surveys with hard to reach populations. For more information visit www.inflexxion.com.

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 21E 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 include statements regarding the expected features and characteristics of KP201 and Apadaz™, and the anticipated timelines for any IND or NDA submission or the availability of clinical trial results. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm 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: KemPharm's financial resources and whether they will be sufficient to meet KemPharm'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 KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; obligations to third parties regarding the potential commercialization or sale of KP201 and Apadaz™; and the FDA approval process, including without limitation any timelines for related approval. KemPharm'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 KemPharm's Quarterly Report on Form 10-Q for the period ended March 31, 2017, and KemPharm’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.

Investor Contacts: Jason Rando / Joshua Drumm, Ph.D. Tiberend Strategic Advisors, Inc. 212-375-2665 / 2664 jrando@tiberend.com jdrumm@tiberend.com Contact for Inflexxion: Jeannette Pforr Inflexxion, Inc. 617-614-0425 jpforr@inflexxion.com Media Contact: Daniel L. Cohen Executive VP, Government and Public Relations KemPharm, Inc. 202-329-1825 dcohen@kempharm.com

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