KemPharm, Inc., a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary new molecular entity (NME) prodrugs, announced today that it received a No Objection Letter (NOL) from Health Canada to begin clinical trials in Canada for its lead product candidate KP201 (benzhydrocodone hydrochloride and acetaminophen).
KP201 is KemPharm's hydrocodone prodrug in development for acute moderate to moderately severe pain. The Health Canada NOL certification follows KemPharm's recent initiation of human abuse liability and human gastrointestinal (GI) motility trials of KP201 in the United States.
Separately, KemPharm joined The Center for Lawful Access and Abuse Deterrence (CLAAD) in supporting Health Canada's recently issued Notice of Intent for Interested Parties on Tamper Resistance under the Controlled Drugs and Substances Act. If approved, the proposed legislation would require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties, i.e., properties that resist crushing, cutting, chewing, dissolution or other forms of tampering, in order to be sold in Canada. KemPharm believes its pipeline of opioid-based prodrug therapeutic candidates in development, including KP201, have potential tamper resistant and abuse deterrent properties that are in line with Health Canada's proposed regulations.
Travis C. Mickle, Ph.D., President and CEO of KemPharm, commented, "Prescription opioid abuse is an epidemic, and KemPharm is at the forefront of developing technologies and supporting policy that deter the abuse and misuse of these otherwise beneficial medications. With this in mind, we welcome the opportunity to initiate clinical trials of KP201 in Canada as its government considers legislation that could require prescription opioids to have tamper-resistant properties in order to be sold in the country."
Mickle continued, "The Notice of Intent from Health Canada combined with the U.S. Drug Enforcement Administration's recent decision to move hydrocodone combination products from Schedule III to Schedule II demonstrate that public sentiment and government policy are aligning. KemPharm fully supports these efforts, and we look forward to continuing the development of our pipeline of opioid prodrugs, including KP201."
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