KemPharm to Present Clinical Data for KP511, an Opioid Prodrug Candidate, at the International Conference on Opioids
June 09 2017 - 7:30AM
Poster Presentation Highlights Intranasal Abuse
Deterrence Technology
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)
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 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
StatementsThis 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.
Investor Contacts:
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com
Media Contact:
Daniel L. Cohen
Executive VP, Government and Public Relations
KemPharm, Inc.
202-329-1825
dcohen@kempharm.com
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