FDA Grants Priority Review to KemPharm for KP201/APAP NDA
If Approved, KP201/APAP Could Become the First Immediate-Release Hydrocodone Combination Product With Abuse-Deterrent Properties
CORALVILLE, Iowa, Feb. 10, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH) today announced that the New Drug Application (NDA) for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA). In addition, the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.
KP201/APAP, an immediate release (IR) combination of KemPharm’s prodrug of hydrocodone, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP), was developed to potentially deter certain common methods of abuse and may also limit excessive opioid exposure in patients and non-medical users compared to currently available hydrocodone combination products. Hydrocodone/acetaminophen products (commonly known by the brand names Vicodin®, Norco® and Lortab®) are among the most prescribed and the most widely abused (non-medical use) medications in the United States.[i],[ii] Currently there are no abuse-deterrent IR hydrocodone combination products approved by the FDA.
“We believe this milestone brings us one step closer to providing prescribers and patients with a new acute pain treatment option that may deter certain common methods of abuse while providing the same pharmacokinetic and therapeutic effect as currently available immediate-release hydrocodone/APAP medications,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “Equally important, we are pleased that the FDA has agreed to a priority review of the NDA with a target PDUFA date of June 9th, which is sooner than was previously anticipated. We look forward to working closely with the agency over the coming months as it considers this potential new option for physicians who are treating patients with acute pain.”
In the NDA submission, KemPharm requested the FDA to recommend that KP201/APAP be classified as a Schedule III controlled substance. This request is based on what KemPharm believes is the reduced potential for abuse and the potential safety features attributable to lower exposure levels to hydrocodone for KP201/APAP as compared to other hydrocodone/APAP products, which are designated as Schedule II. In addition, based on the results of the human abuse liability program completed for KP201/APAP, as well as feedback from the FDA, KemPharm believes there may be support for Category 1, Category 2 and potentially Category 3 abuse-deterrent language in the KP201/APAP product label, if approved by the FDA.
KemPharm developed KP201/APAP using the Company’s proprietary Ligand-Activated Technology (LAT), which creates a new prodrug by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. Once administered, human metabolic processes, such as those in the gastrointestinal tract, separate the ligand from the prodrug and release the parent drug, which can then provide its therapeutic effect.
Caution Concerning Forward Looking Statements
[i] IMS Institute for Healthcare Informatics, Medicine Use and Spending Shifts: A Review of the Use of Medicines in the US in 2014, April 6, 2015 https://www.imshealth.com/files/web/IMSH%20Institute/Reports/Medicines_Use_and_Spending_Shifts/Medicine-Spending-and-Growth_1995-2014.pdf
[ii] National Survey on Drug Use and Health 2014, Substance Abuse and Mental Health Services Administration, Table 1.89A http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs2014/NSDUH-DetTabs2014.htm#tab1-89a
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