Poster Presentation Highlights Intranasal Abuse Deterrence Technology
CORALVILLE, Iowa, June 09, 2017 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, will present clinical data for its opioid prodrug product candidate, KP511, KemPharm’s prodrug of hydromorphone, at the International Conference on Opioids (ICOO) Annual Meeting, to be held June 11-14, 2017.
“We believe the clinical findings we are presenting at ICOO for KP511 demonstrate the potential of our LATTM (Ligand Activated Therapy) Platform for Prodrug Discovery to provide a deterrent to the non-oral abuse of hydromorphone, a potent mu opioid with high rates of non-oral abuse,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm.
The poster, titled, “Pharmacokinetics and Abuse Potential of KP511, a Novel Prodrug of Hydromorphone, after Intranasal Administration in Recreational Drug Users,” reports the results of a study designed to assess the pharmacokinetics and abuse potential of equimolar doses of KP511 hydrochloride active pharmaceutical ingredient (API) (16.1 mg) compared with hydromorphone (HM) hydrochloride (HCl) API (8 mg) following intranasal administration in the studied non-dependent, recreational opioid users.
In the study, KemPharm observed the following:
Pharmacokinetic findings (PK)
- Intranasal KP511 demonstrated marked reductions in the rate and extent of plasma hydromorphone exposure when compared with intranasal HM HCl. Peak concentration (Cmax) was reduced by approximately 63% and mean overall HM exposure was approximately 58% and 48% lower as measured by AUClast and AUCinf, respectively, with KP511 as compared to HM HCl.
Pharmacodynamic findings (PD)
- Consistent with the PK data, intranasal KP511 demonstrated reductions in FDA-recommended human abuse-related endpoints compared with intranasal HM HCl. “At-the-moment measures” of Drug Liking Emax and Feeling High Emax, and retrospective measures of Take Drug Again and Overall Drug Liking, were all significantly reduced for intranasal KP511 (p<0.0052 for all comparisons).
- KP511 was also associated with significantly higher nasal-related effects with respect to Facial Pain (p=0.007), Nasal Burning (p<0.001), Need to Blow Nose (p=0.011) and Runny Nose (p<0.001)
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its LATTM (Ligand Activated Therapy) platform technology. KemPharm utilizes its LATTM platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, attention deficit hyperactivity disorder (ADHD) and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415, an extended-release prodrug of methylphenidate 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.
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/IR, KP415 and KP511. 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 KP415 or KP511; 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.
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
Daniel L. Cohen
Executive VP, Government and Public Relations