KemPharm to Present Data from Pharmacokinetic Trial for Investigational Prodrug Benzhydrocodone at the 2016 International Conference on Opioids

CORALVILLE, Iowa, June 06, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that it will present data from a study (KP201.A03) evaluating the pharmacokinetics and intranasal abuse potential of benzhydrocodone hydrochloride (HCI) (also known as KP201) at the 2016 International Conference on Opioids (ICOO) in Boston, MA. KP201 is a prodrug formed by a covalent bond between hydrocodone and benzoic acid and is designed to be an abuse-deterrent opioid product.

The poster titled, “Pharmacokinetics and Abuse Potential of Benzhydrocodone, a Novel Prodrug of Hydrocodone, After Intranasal Administration in Recreational Drug Users,” (Abstract #38, Monday, June 6, 8:00am ET) provides a review of the full data package from the KP201.A03 trial. Top-line results from KP201.A03 were reported by KemPharm in August 2015 and are included below.

“This study demonstrated both slower hydrocodone onset and decreased peak drug liking of KP201 which is consistent and important,” said Lynn Webster, MD, Vice President of Scientific Affairs at PRA Health Sciences, one of the study’s lead investigators. “The lower hydrocodone exposure seen with KP201 when nasally insufflated is also notable, as reducing the risk of excessive opioid exposure may correspond to reduced abuse potential in individuals at risk for opioid abuse. These findings are significant given that medications containing hydrocodone are both the most prescribed and most commonly abused opioids in the U.S.”

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 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, attention deficit hyperactivity disorder and other central nervous system disorders.

Poster Specifics

“Pharmacokinetics and Abuse Potential of Benzhydrocodone, a Novel Prodrug of Hydrocodone, After Intranasal Administration in Recreational Drug Users”

In KP201.A03, it was observed that peak hydrocodone plasma concentration (Cmax) was 36.0% lower, and total hydrocodone exposures (AUClast and AUCinf) were 20.3% and 19.5% lower, respectively, for intranasal (IN) KP201 compared to IN hydrocodone (HB) (p<0.0001). Reductions in exposure were particularly apparent at early time points after dosing, with a ≥75% reduction in hydrocodone exposure for IN KP201 relative to IN HB at all time intervals up to 1-hour post-dose.

Drug Liking, as expressed on a 100-point Visual Analogue Scale (VAS), mirrored the pharmacokinetic findings, with reductions in Drug Liking for IN KP201 vs. IN HB at early time intervals through 1-hour post-dose. Peak drug liking, as measured by Emax on the Drug Liking -(VAS), was also lower for IN KP201 than IN HB (67.4 vs 73.2, p=0.004). Ease of Insufflation (i.e., snorting) was more difficult with IN KP201 than IN HB, (78.7 vs 65.6 on a 100-point VAS, p=0.0004).

KP201.A03 was a randomized double-blind, two-way crossover study conducted in human subjects to compare the abuse potential of KP201 and hydrocodone following intranasal administration in non-dependent, recreational drug users. Sixty-six (66) subjects entered the treatment phase and 51 subjects completed the study. The primary endpoint of the study was to compare the pharmacokinetics of equimolar doses of IN KP201, 13.34 mg relative to IN HB, 15 mg. A secondary endpoint was the comparison of the Emax of DL-VAS between IN KP201 IN HB. KP201.A03 was one of a series of human abuse liability studies conducted by KemPharm to assess the abuse liability of KP201, with or without acetaminophen (APAP), via various routes of administration.

KP201 is a new molecular entity (NME) built on KemPharm’s proprietary LAT technology, which is intended to confer molecular-level abuse-deterrent properties to the medication. KP201 is designed to remain inactive until it is metabolized in the intestinal tract to release active hydrocodone. KemPharm’s lead drug candidate, Apadaz™, an immediate-release (IR) combination product composed of KP201 and APAP, is currently under review by the U.S. Food and Drug Administration (FDA). The company is also developing KP201/IR as an APAP-free hydrocodone prodrug and expects to submit a New Drug Application (NDA) for this compound in 2017.

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 Apadaz by the FDA or the expected timing of the submission of an NDA for KP201/IR. 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, and in 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 Media Contact: Jim Heins Cooney Waters Unlimited 212-886-2221