KemPharm is a clinical stage, specialty pharmaceutical company engaged in the development and discovery of proprietary prodrugs that are designed to be improved versions of widely prescribed and FDA approved products.
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
Celebration, FL – September 10, 2020 – 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.
CCP 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.
Per the 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.
Dr. 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.”
“The 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 medical needs.”
“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.”
“KVK 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.”
KemPharm 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:
Sure 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.
Founded 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.
APADAZ® 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.
APADAZ® 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 inadequate.
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 adequate analgesia.
Important Safety Information:
APADAZ® 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 operating machinery.
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 MAOI.
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:
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:
APADAZ® 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):
To 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,
- counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
- emphasize 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.
APADAZ® 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:
Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
- 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:
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, 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.