KemPharm to Present Data From Oral Human Abuse Liability Study for Investigational Drug KP201/APAP at the 2016 AAPM Annual Meeting

CORALVILLE, Iowa, Feb. 19, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH) announced that it will present data from an oral human abuse liability, pharmacokinetic and safety study (KP201.A01) of KP201/APAP, today at the 32nd Annual Meeting of the American Academy of Pain Medicine (AAPM) in Palm Springs, CA. KP201/APAP is an immediate release combination of KP201, KemPharm's prodrug of hydrocodone and acetaminophen (APAP) which is being developed as an abuse-deterrent immediate release prodrug of hydrocodone bitartrate/APAP.

The poster titled, “Oral Abuse Potential of Benzhydrocodone, a Novel Prodrug of Hydrocodone,” will provide a review of the full data package from the KP201.A01 trial. Top-line results from KP201.A01 were reported by KemPharm in June 2015.

In the KP201.A01 trial, it was observed that KP201/APAP was associated with lower exposure to hydrocodone at the 8 and 12 tablet doses compared to Norco® (hydrocodone bitartrate/APAP), while exposure at the low-dose (4 tablets) was bioequivalent. Approximately 25% and 34% of subjects demonstrated a 20% or greater reduction in Cmax and AUC0-1 measures of exposure to hydrocodone, respectively, within the first hour at the 12 tablet dose of KP201/APAP as compared to an equivalent dose of Norco. The safety profile of KP201/APAP was comparable to that of Norco. In addition, the 8 and 12 tablet doses of KP201/APAP showed a lower incidence of hypoxia as compared to equivalent doses of Norco. Drug liking, as measured by Emax on the Drug Liking Visual Analogue Scale (DL-VAS), was similar for KP201/APAP and Norco at each equivalent dose. KemPharm believes this may be due to the large amount of APAP acting as a second analgesic.

“These results demonstrate that KP201/APAP may potentially lower exposure to hydrocodone and reduce the incidence of hypoxia at high oral doses, suggesting the potential for improved safety following overconsumption or overdose of KP201/APAP,” explained Sven Guenther, Ph.D., Executive Vice President of Research and Development for KemPharm. "Additional trials are planned to further explore the potential safety benefits of KP201. We are not aware of any other opioid that shows a reduction in relative exposure at high doses."

KP201.A01 was a randomized, double-blind, placebo-controlled, single-dose, 7-way crossover study conducted in human subjects to compare the abuse potential of KP201/APAP, 6.67 mg/325 mg, and Norco, 7.5 mg/325 mg, following oral administration in non-dependent, recreational drug users. Seventy-one (71) subjects entered the treatment phase and 62 subjects completed the study. The endpoints for the study were the comparison of the Emax of DL-VAS between matching dose levels of high- (12 tablets), mid- (8 tablets), and low-dose (4 tablets) of KP201/APAP and Norco, determination of the relative bioavailability of KP201, hydrocodone, hydromorphone, and APAP in plasma from KP201/APAP compared with Norco, and comparison of the incidence and severity of adverse events between the comparator drugs. KP201.A01 was one of a series of human abuse liability studies conducted by KemPharm to assess the abuse liability of KP201, with or without APAP, via various routes of administration.

KP201/APAP is an immediate release (IR) combination of KemPharm’s prodrug of hydrocodone, KP201 (benzhydrocodone hydrochloride), and APAP. It was developed to potentially deter certain common methods of abuse and may also limit excessive opioid exposure in patients and non-medical users compared to currently available hydrocodone combination products. Hydrocodone/APAP products (commonly known by the brand names Vicodin®, Norco and Lortab®) are among the most prescribed and the most widely abused (non-medical use) medications in the United States.i, ii Currently there are no abuse-deterrent IR hydrocodone combination products approved by the FDA.

The New Drug Application for KP201/APAP was recently accepted and granted priority review by the U.S. Food and Drug Administration (FDA). The FDA set a target action date under the Prescription Drug User Fee Act of June 9, 2016.

KemPharm developed KP201/APAP using the Company’s proprietary Ligand Activated Technology (LAT), which creates a new prodrug by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. Once administered, human metabolic processes, such as those in the gastrointestinal tract, separate the ligand from the prodrug and release the parent drug, which can then provide its therapeutic effect.

About KemPharm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of prodrugs to treat serious medical conditions through its 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 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 timing of approval, if at all, of KP201/APAP by the FDA. 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; and the FDA approval process under the Section 505(b)(2) regulatory pathway, 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 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.

i IMS Institute for Healthcare Informatics, Medicine Use and Spending Shifts: A Review of the Use of Medicines in the US. In 2014, April 6, 2015

ii National Survey on Drug Use and Health 2014 , Substance Abuse and Mental Health Services Administration, Table 1.89A

Investor Contacts: Jason Rando / Joshua Drumm, Ph.D. Tiberend Strategic Advisors, Inc. 212-375-2665 / 2664 Media Contact: Jim Heins Cooney Waters Unlimited 212-886-2221