KemPharm’s Commercial Partner for APADAZ®, KVK-Tech, Enters into Collaboration Agreement with Sure M
Thursday, September 10, 2020
Partner for APADAZ®, KVK-Tech, Enters into Collaboration Agreement with
Sure Med Compliance Focused on Improving Prescribing Education and
Compliance for Pain Therapies
Pilot program initially launching in Alabama aligns APADAZ with Sure Med’s Care Continuity Program® to collect data and create a more informed opioid prescribing environment
Fla., Sept. 10, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB:
KMPH), a specialty pharmaceutical company engaged in the discovery and
development of proprietary prodrugs, today announced that its commercial
partner for APADAZ®, KVK-Tech, Inc. (KVK), has entered a
collaboration agreement with Sure Med Compliance (Sure Med), a
mission-based organization focused on supporting physicians in combating
the opioid epidemic through greater prescribing education and
compliance. The program aligns APADAZ (benzhydrocodone and
acetaminophen tablets, CII) with Sure Med’s Care Continuity Program®
(CCP) in a new study program to generate anonymized patient outcome and
utilization data that will measure the impact of switching patients
from other hydrocodone/acetaminophen products to APADAZ, where
appropriate. KVK and Sure Med Compliance will initially launch the
program in Alabama with additional states expected to follow.
is a proprietary software as a service (SaaS) platform that informs
opioid prescribers of patient risks and therapy benefits in order to
identify and document a patient’s suitability for opioid therapy.
APADAZ is a combination of benzhydrocodone, a prodrug of hydrocodone,
and acetaminophen that has been approved by the U.S. Food and Drug
Administration (FDA) and is intended for the short-term (no more than 14
days) management of acute pain.
collaboration agreement, Sure Med and KVK will develop a patient and
provider support program to provide education to physicians, pharmacies,
and patients regarding responsible opioid therapy. Participating
physician groups and pharmacies will utilize Sure Med’s compliance tools
to document consideration of legitimate medical purpose for opioid
therapy. The program will also introduce APADAZ as a responsible
alternative for opioid therapy, where appropriate, and collect
utilization and patient outcome data related to the use of APADAZ as a
replacement for branded and generic prescription opioid products.
David Herrick, Founder of The Center for Pain, former President of the
Alabama Medical Association and Sure Med’s Chief Medical Officer, said,
“The joint effort between Sure Med Compliance, KVK Tech and KemPharm
will give our doctors greater access to opioid-specific education and to
the Care Continuity Program, which has been a proven tool to help
mitigate the risks associated with opioid prescribing.”
collaboration between KVK and Sure Med is an exciting development in
the ongoing commercialization efforts for APADAZ. This new
collaboration represents an innovative opportunity to gather relevant
data needed to assess the effectiveness of APADAZ in improving patient
outcomes while also raising awareness for responsible prescription
opioid administration through physician education and the use of
compliance software,” said Travis C. Mickle, Ph.D., President and Chief
Executive Officer of KemPharm. “By aligning APADAZ with Sure Med’s
Care Continuity Program, participating physicians will gain access to a
full prescribing suite that is focused on delivering the optimal course
of treatment for each individual patient based on his or her specific
“At Sure Med Compliance, our
primary objective is to support physicians by providing the tools and
resources needed to fight the opioid epidemic. In pursuit of this
mission, we seek to align ourselves with forward-thinking companies,
such as KVK and KemPharm, that believe prescription opioids remain a
valuable pain therapy when administered responsibly,” said John Bowman,
Chief Executive Officer of Sure Med Compliance. “Data from this program
will help determine if programs like these can lead prescribing
decisions toward more responsible use of controlled substances.”
welcomes the opportunity to partner with Sure Med and leverage its
expertise in prescription opioid compliance as we work to bring APADAZ
to patients who may benefit most from mitigating the risks associated
with prescription opioid use,” said Anthony Tabasso, Chief Executive
Officer of KVK. “We believe the state of Alabama is an ideal geography
to launch the pilot for this program given the level of payor access for
the authorized generic of APADAZ in the state, the network of
physicians already established by Sure Med, and the desire of the
leading physician groups and associations within the state to forge
innovation in the responsible usage of prescription opioids.”
is a specialty pharmaceutical company focused on the discovery and
development of proprietary prodrugs to treat serious medical conditions
through its proprietary LAT® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT®
technology to generate improved prodrug versions of FDA-approved drugs
as well as to generate prodrug versions of existing compounds that may
have applications for new disease indications. KemPharm’s prodrug
product candidate pipeline is focused on the high need areas of
attention deficit hyperactivity disorder, or ADHD, and stimulant use
disorder. KemPharm’s co-lead clinical development candidates for the
treatment of ADHD, KP415 and KP484, are both based on a prodrug of
d-methylphenidate, but have differing duration/effect profiles. In
addition, KemPharm has received FDA approval for APADAZ®, an
immediate-release combination product containing benzhydrocodone, a
prodrug of hydrocodone, and acetaminophen. For more information on
KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.
About Sure Med Compliance:
Med Compliance has a vision of ending the opioid epidemic through
greater prescribing compliance. This is achieved through training, chart
auditing, software integration and providing physicians with a written
diversion control plan. In a short period of time, Sure Med Compliance
has made a big impact on prescribing habits in the Southeast United
States and become the market leader in opioid prescribing compliance.
in 2004, KVK-Tech has fast become a trusted leader in generics.
KVK-Tech’s business philosophy is built on a commitment to excellence
with a focus on three core values: Safety, GMP Compliance, and
Productivity. KVK-Tech focuses on sustainable growth through continuous
improvement and respect for its customers, employees, and community.
KVK-Tech is focused on improving the way it does business by listening
to all the people who are involved in making healthcare decisions, from
patients to healthcare providers. KVK-Tech’s dedicated team is
comprised of individuals with the technical, clinical and business
expertise that is necessary for innovation that results in the
development of a diverse range of life-changing medicines for patients
of all socio-economic levels.
All of KVK-Tech’s
products are made in the U.S. in a state-of-the-art facility in Newtown,
PA. Currently, KVK-Tech is building a sterile injectable plant nearby
and is on the verge of completing the initial fit-out of the former
Lockheed-Martin complex in Newtown. KVK-Tech is committed to maintaining
its entire business operations in America, and it continues to build
strong, lasting relationships with the nation’s largest pharmacy chains,
wholesalers and distributors.
was developed from KemPharm’s proprietary LAT™ (Ligand Activated
Therapy) platform technology and is intended for the short-term (no more
than 14 days) management of acute pain severe enough to require an
opioid analgesic and for which alternative treatments are inadequate.
APADAZ is differentiated from other prescription opioids as it is the
first FDA-approved product to contain a prodrug of hydrocodone. A
prodrug is chemically inert, or inactive, on its own. When ingested,
enzymes in the gastrointestinal tract cleave the ligand from the prodrug
(benzhydrocodone) and release the parent drug (hydrocodone), which can
then exert its therapeutic effect. The final approved product labeling
for APADAZ includes these and other data points but concludes that the
overall results of the clinical program did not demonstrate
abuse-deterrence by current measurement standards.
The approval of APADAZ via the 505(b)(2) pathway was based in part on pharmacokinetic studies with Vicoprofen®, Ultracet®, and Norco®
in which APADAZ demonstrated exposure to hydrocodone and acetaminophen
(APAP) that is expected to result in therapeutic effects equivalent to
currently approved immediate-release hydrocodone/APAP combination
products when administered orally as intended.
contains an opioid agonist and acetaminophen and is indicated for the
short-term (no more than 14 days) management of acute pain severe enough
to require an opioid analgesic and for which alternative treatments are
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve APADAZ®
for use in patients for whom alternative treatment options [e.g.,
non-opioid analgesics] have not been or are not expected tolerated, or
have not provided adequate analgesia, or are not expected to provide
Important Safety Information:
is contraindicated in patients with: significant respiratory
depression; acute or severe bronchial asthma in an unmonitored setting
or in absence of resuscitative equipment; known or suspected
gastrointestinal obstruction, including paralytic ileus; and
hypersensitivity to hydrocodone or acetaminophen.
APADAZ® contains benzhydrocodone, a Schedule II controlled substance. APADAZ® can be abused and is subject to misuse, addiction, and criminal diversion.
Potential risks associated with APADAZ®
include addiction, abuse, and misuse, life-threatening respiratory
depression, neonatal opioid withdrawal syndrome, risks of concomitant
use or discontinuation of cytochrome P450 CYP3A4 inhibitors and
inducers, acetaminophen hepatoxicity risks from concomitant use with
benzodiazepines or other central nervous system (CNS) depressants, risk
of life-threatening respiratory depression in patients with chronic
pulmonary disease or in elderly, cachectic, or debilitated patients,
adrenal insufficiency, severe hypotension, serious skin reactions, risks
of use in patients with increased intracranial pressure, brain tumors,
head injury, or impaired consciousness, hypersensitivity/anaphylaxis,
risks of use in patients with gastrointestinal conditions, risk of use
in patients with seizure disorders, and withdrawal, risks of driving and
Potential drug interactions with APADAZ® include:
- Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue APADAZ® if serotonin syndrome is suspected.
- Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with APADAZ® because they may reduce analgesic effect of APADAZ® or precipitate withdrawal symptoms.
- Monoamine Oxidase Inhibitors (MAOIs): Can
potentiate the effects of hydrocodone. Avoid concomitant use in
patients receiving MAOIs or within 14 days of stopping treatment with an
Most common adverse reactions (>5%) are nausea, somnolence, vomiting, constipation, pruritus, dizziness, and headache.
The Full Prescribing Information for APADAZ® contains the following Boxed Warning:
ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY
(REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION;
HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse:
exposes patients and other users to the risks of opioid addiction,
abuse, and misuse, which can lead to overdose and death. Assess each
patient’s risk prior to prescribing APADAZ® and monitor all patients regularly for the development of these behaviors and conditions.
Risk Evaluation and Mitigation Strategy (REMS):
ensure that the benefits of opioid analgesics outweigh the risks of
addiction, abuse, and misuse, the Food and Drug Administration (FDA) has
required a REMS for these products. Under the requirements of the REMS,
drug companies with approved opioid analgesic products must make
REMS-compliant education programs available to healthcare providers.
Healthcare providers are strongly encouraged to
- complete a REMS-compliant education program,
patients and/or their caregivers, with every prescription, on safe use,
serious risks, storage, and disposal of these products,
to patients and their caregivers the importance of reading the
Medication Guide every time it is provided by their pharmacist, and
- consider other tools to improve patient, household, and community safety.
Life-Threatening Respiratory Depression:
Serious, life-threatening, or fatal respiratory depression may occur with use of APADAZ®. Monitor for respiratory depression, especially during initiation of APADAZ® or following a dose increase.
Accidental ingestion of even one dose of APADAZ®, especially by children, can result in a fatal overdose of hydrocodone.
Neonatal Opioid Withdrawal Syndrome:
Prolonged use of APADAZ®
during pregnancy can result in neonatal opioid withdrawal syndrome,
which may be life-threatening if not recognized and treated, and
requires management according to protocols developed by neonatology
experts. If prolonged opioid use is required in a pregnant woman,
advise the patient of the risk of neonatal opioid withdrawal syndrome
and ensure that appropriate treatment will be available.
Cytochrome P450 3A4 Interaction:
The concomitant use of APADAZ®
with all cytochrome P450 3A4 inhibitors may result in an increase in
hydrocodone plasma concentrations, which could increase or prolong
adverse reactions and may cause potentially fatal respiratory
depression. In addition, discontinuation of a concomitantly used
cytochrome P450 3A4 inducer may result in an increase in hydrocodone
plasma concentration. Monitor patients receiving APADAZ® and any CYP3A4 inhibitor or inducer.
contains acetaminophen. Acetaminophen has been associated with cases of
acute liver failure, at times resulting in liver transplant and death.
Most of the cases of liver injury are associated with the use of
acetaminophen at doses that exceed 4000 milligrams per day, and often
involve more than one acetaminophen-containing product.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants:
use of opioids with benzodiazepines or other CNS depressants, including
alcohol, may result in profound sedation, respiratory depression, coma,
- Reserve concomitant prescribing of APADAZ® and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
For Important Safety Information including full prescribing information, visit: www.kempharm.com
Caution Concerning Forward Looking Statements:
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, including
without limitation the Company’s proposed development and commercial
timelines, 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. Forward-looking statements are
not guarantees of future actions or performance. These forward-looking
statements, including the potential clinical benefits of APADAZ, the
potential results of commercialization efforts by KVK, or the potential
success of KVK and Sure Med’s collaboration, 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. Risks concerning KemPharm’s business
are described in detail in KemPharm’s Annual Report on Form 10-K for
the year ended December 31, 2019, 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/Maureen McEnroe
Tiberend Strategic Advisors, Inc.
(212) 375-2665 / 2664